Xtalks Life Science Podcast

In this episode, Ayesha spoke with Kirk Brown, PhD, Vice President of Research at Alnylam Pharmaceuticals.

Alnylam is focused on developing RNAi medicines to transform the way diseases like cardiovascular and neurological diseases are treated.

Dr. Brown’s preclinical work combining stable siRNA designs with alternative conjugation strategies has enabled potent, long-lasting silencing across the CNS following a single intrathecal administration. 

In addition to driving RNAi platform innovations, Dr. Brown leads a team of CNS target biologists at Alnylam and serves as the research lead for ALN-APP, the first clinical CNS RNAi program.

In this episode, Dr. Brown discusses the promise and evolving landscape of RNAi therapeutics across various therapeutic areas and Alnylam’s approach to developing innovative RNAi medicines.

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In this episode, Ayesha spoke with Jennifer Gudeman, Pharm D, Senior Vice President, Medical and Clinical Affairs, Avadel Pharmaceuticals plc, a biopharmaceutical company working on innovative solutions to the development of medications that disrupt treatment paradigms and address unmet needs. The company is currently focused on developing treatments for narcolepsy, a complex chronic neurological sleep disorder.

Dr. Gudeman joined Avadel in 2020. This was a critical time for the company as the team had submitted an NDA for a treatment that had the potential to improve the standard of care in narcolepsy. Dr. Gudeman helped continue the clinical development of Lumryz (sodium oxybate) through to its approval, which was approved last May and is the first and only FDA approved once-at-bedtime oxybate for individuals living with narcolepsy.

Narcolepsy affects the brain’s ability to regulate sleep-wake cycles. People with narcolepsy experience excessive daytime sleepiness (EDS) and sudden episodes of falling asleep during the day, which can be uncontrollable and occur at inappropriate times.

Tune into the episode to learn more about the unmet needs in narcolepsy, the clinical development and approval of Lumryz and where the science is heading in the sleep disorder space.

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In this episode, Ayesha spoke with Steffen-Sebastian Bolz, MD, PhD, a scientist, physician and entrepreneur. He is a Co-Founder of Aphaia Pharma AG and Founder and Chief Scientific and Medical Officer at Qanatpharma AG. Dr. Bolz holds a full professorship at the University of Toronto, is a Principal Investigator at the Ted Rogers Centre for Heart Research and Director of the Toronto Centre for Microvascular Medicine.

Aphaia Pharma is developing innovative, non-hormonal treatments for metabolic conditions like diabetes and obesity. The company is focused on restoring a normal metabolic food response through natural and safe treatment alternatives that can be applied to broad populations and enable long-term use.

To learn more about Aphaia’s innovative approach to treating metabolic conditions like obesity by turning to the body’s natural physiology, tune into the episode with Dr. Bolz.

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In this episode, Ayesha spoke with Alessio Travaglia, PhD, neuroscientist and Director Neuroscience at the Foundation for the National Institutes of Health (FNIH) and Suzanne Schindler, MD, PhD, Associate Professor of Neurology at Washington University.

Results from a head-to-head study led by the FNIH Biomarkers Consortium, with data analysis led by Dr. Schindler, have shown that some commercial diagnostic blood tests are accurate enough for clinical use and could replace cerebrospinal fluid (CSF) tests and PET scans in the near future for the diagnosis of Alzheimer’s disease. This would save patients the cost and pain associated with these traditional diagnostic approaches. The findings were presented at the Alzheimer’s Association International Conference (AAIC) in Philadelphia recently.

The findings could improve clinical diagnosis and speed future drug development by helping researchers select optimal clinical trial participants.

Tune into the episode to hear from Dr. Schindler and Dr. Travaglia about the promise of the blood tests for Alzheimer’s diagnosis.

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In this episode, Ayesha spoke with Matthew Martinez, MD, a board-certified cardiologist and nationally recognized expert in hypertrophic cardiomyopathy (HCM). He serves as director of Atlantic Health System Sports Cardiology and the director of the Chanin T. Mast Center for Hypertrophic Cardiomyopathy.

Dr. Martinez is the Chair of ACC online “LEARNHCM” platform, which educates clinicians about HCM patient care. Dr. Martinez also serves as a cardiology consultant for elite and professional athletes including acting as the League cardiologist for Major League Soccer, team cardiologist for the New York Jets and cardiac consultant for the NFL and NHL.

The American Heart Association (AHA)/American College of Cardiology (ACC) Joint Committee on Clinical Practice Guidelines recently published a new clinical guideline for the evaluation and management of people with hypertrophic cardiomyopathy (HCM), which Dr. Martinez co-authored.

The guidelines now recommend CAMZYOS (mavacamten), the first and only FDA approved cardiac myosin inhibitor, as a Class 1 Level B-R therapy for the treatment of adults with obstructive HCM who have persistent symptoms after first-line therapy.

Tune into the episode to hear Dr. Martinez’s expert insights on the significance of the updated guidelines, the firsthand and real-world application of CAMZYOS in clinical practice and HCM care for everyday individuals to high level athletes.

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In this episode, Ayesha spoke with Lawreen Asuncion, a patient advocate who works to raise awareness for the rare disease Usher syndrome.

Lawreen has worked professionally in the biotech and life science markets for over 25 years. She provides input and perspectives for rare genetic disease programs and clinical trials sponsored by biotech and pharma companies.

Lawreen is a dedicated patient advocate for Usher syndrome, a rare genetic disorder that causes both hearing and vision loss in most individuals, and also balance for some. As someone living with Usher syndrome type 2c, Lawreen brings a deeply personal perspective to her advocacy work, sharing her experiences and challenges to raise awareness and educate others about the condition. Her advocacy extends to supporting research initiatives and promoting accessibility and inclusion for individuals with sensory impairments.

Tune into the episode to hear Lawreen’s perspectives as both a life sciences professional and rare disease patient advocate.

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In this episode, Ayesha spoke with Moreno Perugini, President of Active & Medical Nutrition, US & President of Global Pharmaceutical Therapies at Nestlé Health Science US.

As President of Global Pharmaceutical Therapies, Moreno and his team actively shape the healthcare system through innovative approaches and a strong commitment to delivering pharmaceutical products with a human-centered focus.

Throughout his career spanning over two decades, he has held leadership positions at pharmaceutical companies like AbbVie and Novartis. Notably, he has been instrumental in bringing multiple pharmaceutical technologies to market, across different therapeutic areas guided by his unwavering commitment to prioritizing patients and expanding access to treatment.

Moreno holds a master's degree in Pharmacoeconomics/Pharmaceutical Economics from Universität Pompeu Fabra – IDEC and an MBA from Bocconi.

Last year, Nestlé Health Science won FDA approval for Vowst (Ser-109) for the prevention of recurrent C. difficile infections. Moreno discusses the significance of the approval given the difficulty of treating the recurrent infections, which are usually acquired during hospital stays.

Tune into the episode to hear more about the work Moreno is leading at Nestlé Health Science, which includes both nutrition- and pharmaceutical-based treatments for GI conditions and gut health.

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In this episode, Ayesha spoke with Jerry McLaughlin, chief executive officer and board member of Life Biosciences, a company advancing innovative cellular rejuvenation platforms to reverse diseases of aging.

Life Biosciences is developing a gene therapy for primary open-angle glaucoma (POAG) and non-arteritic anterior ischemic optic neuropathy (NAION), two types of optic neuropathies with significant unmet needs. The company is developing innovative therapies for these indications that are based on innovative partial epigenetic reprogramming and chaperone-mediated autophagy technologies.

Jerry McLaughlin has over 30 years of experience in the biopharmaceutical industry and has been involved in the discovery, clinical development and global commercialization of more than a dozen FDA-approved drugs with multiple successful exits. Jerry began his career at Merck and was extensively involved in multiple blockbuster product launches. Most recently, Jerry was President and CEO for Neos Therapeutics, Inc., a commercial stage pharmaceutical company. He holds a BA in economics from Dickinson College and an MBA from the Villanova School of Business.

Tune into the episode to learn more about the work Jerry is leading at Life Biosciences to better understand and target the biology of aging through innovative therapeutics for aging-related diseases with critical unmet medical needs.

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In this episode, Ayesha spoke with Karen S. Ho, PhD, Vice President, Translational Medicine at Clene Nanomedicine, a biopharmaceutical company focused on developing treatments for neurodegenerative diseases to restore and protect neuronal health and function.

Clene Nanomedicine is developing nanotherapeutics that target cellular energy impairments common to neurodegenerative and many other diseases. Specifically, the company’s lead asset is based on leveraging the catalytic therapeutic activities of gold when engineered as clean-surfaced faceted nanocrystals.

At Clene Nanomedicine, Dr. Ho directs the translation of preclinical successes of Clene’s lead drug assets into high clinical value with applicability to multiple disease areas. Dr. Ho has a PhD in Developmental Biology from Stanford and completed her postdoctoral training as a National Sleep Foundation Pickwick Scholar and Howard Hughes Medical Institute Postdoctoral Fellow at University of Pennsylvania in the Department of Neuroscience. Dr. Ho serves on several rare disease group Scientific Advisory Boards and holds a concurrent position as adjunct faculty at the University of Utah School of Medicine in the Department of Pediatrics, Division of Medical Genetics.

Tune into the episode to learn about Clene Nanomedicines’ innovative gold nanocrystal technology and how Dr. Ho is leading its development in diseases like ALS and Multiple Sclerosis. Also hear about Dr. Ho’s journey in the biopharmaceutical industry, including a touching personal story.

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In this episode, Ayesha spoke with Marci English, Vice President and Head of BioPharma Development at Astellas Pharma about a groundbreaking new treatment that addresses the underlying mechanisms of menopause symptoms.

In May 2023, Astellas received FDA approval for fezolinetant (commercial name Veozah) for the treatment of moderate to severe vasomotor symptoms due to menopause. The therapy is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat vasomotor symptoms associated with menopause, which include hot flashes and night sweats.

Tune into the episode to learn about the latest on fezolinetant one year after its approval, including its reception from healthcare providers and patients.

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In this episode, Ayesha spoke with Lawrence Blatt, PhD, MBA, Chairman and CEO of Aligos Therapeutics, a company developing targeted therapies for liver diseases like MASH (metabolic dysfunction-associated steatohepatitis) and viral diseases to address important unmet medical needs.

Prior to co-founding Aligos Therapeutics, Dr. Blatt served as the Global Head of Infectious Diseases and Vaccines at Janssen Pharmaceutical Companies of Johnson & Johnson from 2014 to 2018. He also co-founded several biotech companies, including Alios BioPharma, which was acquired by Janssen in November 2014. Dr. Blatt previously served on the board of directors of companies including ReViral Ltd. and Alveo Technologies, Inc., which he co-founded in 2014, and Meissa Vaccines, Inc. Dr. Blatt received an MBA from California State University, Northridge, and a PhD in Public Health Administration from the University of La Verne.

In March, Aligos announced the dosing of its first patient in its Phase IIa trial for a novel thyroid hormone receptor-beta agonist (ALG-055009) designed to address the root fibrosis of MASH. The drug is in the same class as Rezdiffra, which was approved this year as the first treatment for MASH.

Aligos also shared positive data at the European Association for the Study of the Liver (EASL) Congress last month in Milan, Italy for one of its candidate therapeutics for chronic hepatitis B (CHB).

Tune into the episode to learn more about the work Dr. Blatt is leading at Aligos Therapeutics in chronic liver disease and viral diseases.

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In this episode, Ayesha spoke with Alessio Travaglia, PhD, Director Neuroscience at the Foundation for the National Institutes of Health (FNIH) who also manages FNIH’s new Accelerating Medicines Partnership in Amyotrophic Lateral Sclerosis (AMP ALS) program, and Nadia Sethi, DDS, an ALS patient advocate who formerly served as Director of Community Outreach and Engagement at the ALS Therapy Development Institute.

Dr. Travaglia has 15 years of experience in basic and translational neuroscience in academia, non-profit, management consulting and venture philanthropy. Dr. Sethi is a patient advocate with strong leadership skills, experienced in patient outreach and representing advocacy organizations. She was a caregiver to her late husband who had ALS.

Last month, the FNIH launched a new AMP ALS research program designed to accelerate the discovery and development of treatment and diagnostics for ALS. The goals of the initiative include the faster identification of biomarkers and clinical outcome assessments that will may aid in earlier diagnosis and help accelerate drug development.

ALS is a neurologic disease with severely limited treatment options, none of which halt or reverse the progression of the fatal condition.

To learn more about the FNIH’s new AMP ALS program, including the continuing importance of patient advocacy and inclusion of the patient and caregiver voice in ALS research, tune into the discussion with Dr. Travaglia and Dr. Sethi.

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In this episode, Ayesha spoke with Joshua Cohen and Justin Klee, co-CEOs and co-founders of Amylyx Pharmaceuticals, a company developing therapeutics for neurodegenerative diseases like amyotrophic lateral sclerosis (ALS).

Josh and Justin co-founded Amylyx Pharmaceuticals in 2013. Josh co-invented the oral, fixed-dose combination AMX0035 (known commercially as Albrioza in Canada and Relyvrio in the US), which is being explored for the potential treatment of neurodegenerative diseases. With a background in biomedical engineering, Josh is passionate about improving outcomes where there is a significant unmet need by pursuing research into novel drug candidates for ALS and other neurodegenerative diseases.

Justin previously conducted research in neural systems in the Moore lab at Brown University and in neurophysiology and Alzheimer’s disease under Dr. Rudolph Tanzi, founding member of Amylyx’ Scientific Advisory Board, at Harvard Medical School to explore new approaches to treating relentlessly progressive neurodegenerative diseases.

In 2020, Josh and Justin were named to Business Insider’s 30 Under 40 in Healthcare list and PM360’s ELITE in the Drug Researchers and Developers category among the many other awards they have won throughout their careers thus far.

Josh and Justin have overseen the growth of Amylyx from its start as a concept dreamed up in a dorm room at Brown University to a global, commercial stage and publicly traded pharmaceutical company hundreds of employees and headquarters in the US, Canada and the Netherlands to support Amylyx’s global operations.

Josh and Justin led the global regulatory approvals of AMX0035 for the treatment of ALS in Canada and the US. In April, Amylyx decided to remove the drug from the US and Canadian markets based on data from a confirmatory trial.

Tune into the episode to learn more about Amylyx’s plans for AMX0035, which include investigations in progressive supranuclear palsy (PSP) and Wolfram syndrome.

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In this episode, Ayesha spoke with Howard McLeod, PharmD, Director of the Center for Precision Medicine and Functional Genomics, Professor of Pharmacy and Medicine at Utah Tech University and Precision Medicine Advisor at the Geriatric Oncology Consortium; and Sharmeen Roy, PharmD, Chief Strategy and Science Officer at DoseMe, which is the world’s first and largest Bayesian dosing platform designed for clinical practice.

Precision dosing, also known as personalized dosing, aims to tailor drug dosages to the individual characteristics of each patient to achieve optimal therapeutic outcomes while minimizing adverse effects. It leverages various patient-specific factors, including genetics, age, weight, organ function and even lifestyle, to determine the most appropriate dosage for each individual. 

Dr. McLeod is an internationally recognized expert in precision medicine, who has made novel contributions at the discovery, translation, implementation and policy levels. Dr. McLeod received his Doctorate in Pharmacy from the Philadelphia College of Pharmacy and Science and completed his Post-Doctoral Training at St Jude Children’s Research Hospital and the University of Glasgow. 

Dr. Roy is passionate about leveraging technology to amplify the impact of the pharmacist. Her career spans pediatric clinical pharmacy, clinical research and pharmacogenomics with leadership roles at University of Chicago Medical Center and PipelineRx. She received her Doctor of Pharmacy degree from the University of Illinois at Chicago, is a Board-Certified Pharmacotherapy Specialist and completed a Pediatric Specialty Pharmacotherapy Residency at Texas Children’s Hospital.

Tune into the episode to learn more about the current landscape of precision dosing, including the latest technologies and tools designed to help optimize drug dosages.

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In this episode, Ayesha spoke with Brian Atwood, Chairman and CEO of CERo Therapeutics, a company pioneering a new generation of autologous T-cell-based therapies for both hematologic and solid tumor cancers. 

Prior to joining CERo, Brian Atwood served as Chairman of the board of directors of Phoenix Biotech Acquisition Corp., which merged with CERo Therapeutics to form CERo Therapeutics Holdings, Inc. Mr. Atwood has founded and co-founded several biotechnology and healthcare-focused companies throughout his career, including Cell Design Labs Inc. where he served as President and Chief Executive Officer until 2018 when it was acquired by Gilead Sciences. He has also served as chairman on the board of directors of numerous biotech companies, including Immune Design Corp. (which was acquired by Merck in 2019), Veracyte and Five Prime Therapeutics among others. Mr. Atwood holds a BS in Biological Sciences from the University of California, Irvine, a MS in Ecology from the University of California, Davis and an MBA from Harvard Business School.

Tune into the episode to learn about CERo’s next-gen T-cell technology and its lead therapeutic candidate, a CER T cell product that contains a phagocyte receptor component. Hear about how it is being employed for AML, a blood cancer that remains among the most challenging cancers to treat.

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In this episode, Ayesha spoke with Sam Lee, PhD, Co-Chief Executive Officer and President of Cocrystal Pharma, a company developing novel antiviral therapeutics against COVID-19 and other coronaviruses, influenza viruses and noroviruses.

Cocrystal Pharma leverages a unique structure-based drug discovery platform, complemented by Nobel Prize-winning expertise, to develop leading-edge antiviral drugs that are both first-in-class and best-in-class. Their antivirals specifically target the viral replication process and are designed for safety, broad-spectrum effectiveness, resistance management and ease of administration.

Dr. Lee brings over 25 years of experience in anti-infective drug discovery research to his role. Before joining Cocrystal, he spent eight years overseeing anti-infective drug discovery initiatives at Icos Corporation. During his tenure at Icos, Dr. Lee integrated protein crystallography and structural screening technologies into the company's research programs and was instrumental in the development of phosphoinositide 3-kinase (PI3K) delta inhibitors, leading to an FDA-approved product. 

Dr. Lee earned his PhD in Biological Sciences from the University of Notre Dame and completed his postdoctoral training in viral biochemistry at Stanford University. While at Stanford, he also established Viral Assays in Cupertino, CA, where he served as CEO.

Tune in to the episode to learn about Cocrystal Pharma’s structure-based drug discovery approach to developing next-gen antiviral treatments.

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In this episode, Ayesha spoke with John Finn, PhD, Chief Scientific Officer at Tome Biosciences, a company developing programmable gene insertion (PGI) technology.

PGI is a cutting-edge gene editing technology that allows for the insertion of large sequences of DNA with site-specific precision. PGI is a revolutionary approach for the development of potentially curative cell and integrative gene therapies. The technology underlies Tome’s investigational candidate therapeutics for autoimmune diseases and the rare metabolic disorder phenylketonuria (PKU) among other conditions.

Dr. Finn has over 20 years of experience in the gene therapy space with a focus on genome editing and delivery technologies. He was most recently Vice President of Discovery Research at Codiak Biosciences, where he led the development of a new class of therapeutics based on engineered exosomes. Prior to Codiak, Dr. Finn was Executive Director of Platform Biology and Liver Discovery at Intellia Therapeutics, where he was responsible for the development of viral and non-viral delivery systems and demonstrated the first in vivo systemic administration of CRISPR-based therapeutics. He has served as an American Society of Gene and Cell Therapy (ASGCT) Committee Member for multiple committees. Dr. Finn trained with Pieter Cullis and Ian MacLachlan and received his PhD in Biochemistry and Molecular Biology from the University of British Columbia.

Tune in to the episode to learn about Tome Biosciences’ innovative gene editing technology and lead therapeutic assets.

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In this episode, Ayesha spoke with Jeremy Levin, D. Phil, MB BChir, CEO and Chairman of Ovid Therapeutics Inc., and Meg Alexander, Chief Strategy Officer at Ovid.

Ovid Therapeutics is a biopharmaceutical company focused on the development of medicines for epilepsies and seizure-related neurological disorders.

Prior to founding Ovid, Dr. Levin was president and CEO of Teva Pharmaceutical Industries and a member of the executive committee at Bristol-Myers Squibb (BMS) Company where he was the architect, lead and implementer of the String of Pearls Strategy, which transformed BMS and facilitated the initiation and massive growth of the immuno-oncology revolution in the biopharmaceutical industry. 

Dr. Levin also serves on the board and executive committee of the Biotechnology Innovation Organization (BIO) as the immediate past chairman. Dr. Levin was voted as one of the 25 most influential biotechnology leaders by Fierce Biotech, one of the top three biotechnology CEOs by The Healthcare Technology Report and one of the PharmaVoice100 CEOs in 2020 and 2021. He was selected by Endpoints in 2021 as one of the 60 living pioneers of the industry, and has received several awards throughout his career. Dr. Levin has practiced medicine at university hospitals in England, South Africa and Switzerland. 

Meg Alexander serves as Ovid’s chief strategy officer, a role in which she oversees and supports the company’s corporate strategy and planning, performance measurement and risk mitigation. She also oversees the company’s corporate affairs function with a focus on engaging Ovid’s stakeholders across patient and caregiver communities, policymakers, press and investors.

Ms. Alexander has worked in the biopharmaceutical industry for two decades and has played a key role in launching more than 25 new medicines for many conditions including rare epilepsies, ALS, HIV, multiple sclerosis, Batten’s disease, cardiovascular disease and cancer. She has advised and led campaigns for large healthcare organizations, including Pfizer, Novartis, Amgen, Eli Lilly, Nestle and Coca-Cola among many others. Prior to Ovid, she founded and led the Reputation & Risk Management Group, a consultancy within Syneos Health, one of the world’s largest clinical research organizations. Ms. Alexander was named a “Disruptor” and a “Rising Star” in her industry by PM360 and the Healthcare Business Women’s Association, respectively.

This year, OVID is expecting several CNS data readouts, including one for its lead product candidate soticlestat, which is currently in Phase III trials for the treatment of refractory seizures in Lennox-Gastaut syndrome and Dravet syndrome, a rare epilepsy with high unmet need.

Tune in to the episode to learn more about Ovid Therapeutics’ developmental pipeline featuring treatments for epilepsies and seizures associated with rare brain conditions. 

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In this episode, Ayesha spoke with William Schaffner, MD, Professor of Preventive Medicine Health Policy and Professor in the Division of Infectious Diseases at Vanderbilt University; and Kelly Moore, MD, MPH, President and CEO at Immunize.org and Associate Professor of Health Policy at Vanderbilt University.

Dr. Schaffner and Dr. Moore discussed the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommendation of a trivalent influenza vaccine strain selection, as opposed to a typical quadrivalent vaccine, with the 2024/2025 influenza season reflecting the removal of the B/Yamagata strain. 

A renowned infectious disease expert, having appeared on numerous media outlets including CNN particularly during the COVID-19 pandemic, Dr. Schaffner’s primary interest has been the prevention of infectious diseases domestically and globally in both pediatric and adult populations. After residency training and a fellowship in infectious diseases at Vanderbilt University, Dr. Schaffner served in the US Public Health Service as an epidemic intelligence service officer with the Centers for Disease Control and Prevention (CDC) in Atlanta. After that tour of duty, Dr. Schaffner joined the faculty at Vanderbilt, establishing a long collaboration with the Tennessee Department of Health. Dr. Schaffner has been a member of numerous expert advisory committees that established national vaccine policy. Dr. Schaffner is also the current medical director and past president of the National Foundation for Infectious Diseases and has served on the executive board for the Infectious Diseases Society of America. 

Prominent infectious disease expert Dr. Moore served for 14 years as the director of the Tennessee Immunization Program and later founded her own consulting company, The Vaccine Advisor, to advise public health and industry before her current role as president and CEO of immunize.org, a leading nonprofit organization focused on national and global vaccine policy and immunization program implementation. Dr. Moore has served in a variety of immunization policy advisory roles with the World Health Organization (WHO) since 2016, including as chair of its Immunization Practices Advisory Committee. Dr. Moore is a graduate of the Vanderbilt School of Medicine and the Harvard School of Public Health. She completed her public health leadership training as an epidemic intelligence service and preventive me

In this episode, Ayesha spoke with Robert Barrow, CEO and Board Director at MindMed, a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders. 

The company is developing innovative psychedelic-based product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.

Mr. Barrow is an accomplished pharmaceutical executive and clinical pharmacologist with over a decade of experience leading drug development programs in a variety of disease areas. After joining MindMed as Chief Development Officer in January 2021, he was named CEO in June 2021. Mr. Barrow has a Masters degree in Pharmacology from The Ohio State University and a Bachelor of Science degree from Wake Forest University, where he graduated summa cum laude and is a CFA charterholder.

Last month, MindMed received FDA Breakthrough Therapy Designation for its MM120 (lysergide d-tartrate) program for the treatment of generalized anxiety disorder (GAD).

The company also announced that a Phase IIb study of MM120 in GAD met its key secondary endpoint, and 12-week topline data demonstrated clinically and statistically significant durability of activity.

 For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/
 
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In this episode, Ayesha spoke with John K. Celebi, MBA, President & Chief Executive Officer, Sensei Bio, a clinical-stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients.

Sensei Biotherapeutics specializes in creating conditionally active antibodies. These are engineered to operate specifically within the tumor microenvironment, enhancing the immune system's ability to combat cancer.

John Celebi, MBA, has over 25 years of experience building innovative entrepreneurial biotechnology companies.

Mr. Celebi currently serves on the Board of Directors of Egle Therapeutics SAS, a biotechnology company developing first-in-class immunotherapies targeting immune suppressor regulatory T cells (Tregs) for oncology and autoimmune diseases.

Mr. Celebi received an MBA from Carnegie Mellon University and a BS in biophysics from the University of California, San Diego.

Tune into the episode to learn more about Sensei Bio’s mission and therapeutic approach.
 
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In this episode, Ayesha spoke with Howard Berman, PhD, Founder and CEO of Coya Therapeutics, a clinical-stage biotech company developing regulatory T cell (Treg) therapies targeting neurodegenerative, autoimmune and metabolic diseases. Dr. Berman founded Coya Therapeutics in 2021. 

Dr. Berman has over 18 years of entrepreneurial and industry experience working at the interplay of science and business. His experience offers him a unique combination of business acumen and scientific credibility with the ability to assess, quantify and bridge both disciplines.

Dr. Berman gained corporate experience with increasing responsibilities and positions as a Medical Science Liaison at AbbVie where he spent 7.5 years launching Venetoclax in CLL and later, supporting numerous solid tumor assets. He also served in leadership roles at Novartis Pharmaceuticals and Eli Lilly.

Dr. Berman received a Bachelor in Biology from the University of Michigan and a Masters and PhD in Neuroscience and Pharmacology from Weill Cornell Medical School.

Tune into the episode to learn more about Coya Therapeutics and its Treg-targeted therapies program. The company’s current pipeline includes its lead candidate product COYA 302, which is currently being evaluated in a clinical study for the treatment of amyotrophic lateral sclerosis (ALS).

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In this episode, Ayesha spoke with Margaret Froh, President of the Métis Nation of Ontario (MNO). Margaret is also a lawyer by training.
 
 The Métis are a distinct Indigenous people recognized in s.35 of Canada’s Constitution. Métis communities have their own shared customs, traditions and collective identities that are rooted in kinship, their special aboriginal relationship to the land and a distinctive Indigenous culture and way of life that persists to the present day.
 
 Cancer is a significant concern among Métis people in Ontario and across the Métis Nation Homeland, including women, as they experience higher cancer rates and lower cancer screening uptake than the non-Indigenous population.
 
 Cancer Prevention Action Week, which took place during the third week of February, focuses on supporting and empowering people to make changes to their lifestyle and promoting routine cancer screening to reduce the risk of preventable cancers.
 
 To help uncover and address cancer disparities among the Métis, Margaret has helped lead Métis-specific health research in collaboration with organizations like Ontario Health (formerly Cancer Care Ontario) and the Sunnybrook Research Institute.
 
 Margaret is also a recent breast cancer survivor and by sharing her personal cancer story, is helping raise awareness about the importance of routine cancer screening among the Métis.
 
 Tune into the episode to learn about the disproportionate impact of cancer on Métis communities and how Margaret’s leadership at the MNO is helping to drive changes to help improve cancer screening rates and better health outcomes.
 
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This episode features an interview with Bruce Culleton, MD, CEO, ProKidney, a late clinical-stage biotech company focused on the development of a pioneering cell therapy candidate that aims to transform the treatment landscape for chronic kidney disease.

Prior to joining ProKidney in 2023, Dr. Culleton served as Vice President and General Manager at CVS Kidney Care and also worked in leadership roles at Becton Dickinson and Baxter healthcare. Before beginning his career in industry in 2007, Dr. Culleton was a Clinical Associate Professor in the Department of Medicine at the University of Calgary.

ProKidney’s lead product candidate, REACT, is an investigational cell therapy designed to stabilize or improve kidney function in patients with chronic kidney disease with diabetes as the primary cause. The candidate is currently being evaluated in Phase II and Phase III clinical trials.

To hear more about ProKidney’s cell therapy for chronic kidney disease, including developmental, manufacturing and regulatory considerations, tune into the episode.

For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/

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In marking National Kidney Month, this episode features an interview with Robert Perkins, MD, Vice President, US Medical Affairs (Renal) at Bayer who spoke about kidney health and diabetes-inflicted chronic kidney disease.

National Kidney Month is observed every March in the US to raise awareness about kidney health and promote preventive action. It aims to educate the public about the importance of kidneys to overall health and the risk factors for kidney disease, a major one being diabetes.

At Bayer, Dr. Perkins is the strategic lead for a team of 8 HQ-based medical directors and a 40-member field medical team. He is responsible for evidence portfolio across two therapeutic indications, chronic kidney disease and heart failure, encompassing seven active trials and studies and more than 3,000 US patients. Dr. Perkins has also led the development and implementation of innovative digital educational outreach campaigns for primary care physicians. In previous roles, Dr. Perkins helped build and develop medical teams at Novartis and AstraZeneca.

Last year, the American Diabetes Association (ADA) updated their standards of care guidelines for 2024, which outline strategies for diagnosing and treating diabetes (both type 1 and type 2) and outline methods of preventing and delaying type 2 diabetes as well as associated comorbidities like cardiovascular disease and chronic kidney disease.

Tune into the episode to hear Dr. Perkins’ insights about current advancements and challenges in tackling chronic kidney disease, the updated ADA guidelines and how a comprehensive approach to treating diabetes is necessary for reducing the risk of kidney complications.

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In this featured episode of Xtalks People in Life Sciences, Ayesha spoke with Ashish Jain, Senior Director of Clinical Safety and Pharmacovigilance (PV) at Curis, a pioneering biotech company specializing in cutting-edge cancer therapies.

Jain shared his journey into clinical safety and PV, highlighting key milestones along the way. Delving into his daily routine at Curis, he revealed his strategies for prioritizing tasks and staying informed of the latest developments in PV.

Throughout the interview, Jain offered invaluable insights into career advancement in clinical safety and PV. He emphasized the indispensable skills and competencies vital for success in the field. Jain also discussed common challenges faced by PV professionals and suggested practical solutions.

Aspiring professionals seeking to kickstart their careers in clinical safety and PV will find Jain’s insights informative. He provides actionable recommendations for gaining hands-on experience and navigating the PV landscape.

Furthermore, Jain shares his expertise in establishing a PV department, particularly for emerging biotech firms. He outlines critical considerations for setting up an efficient PV system, especially in resource-limited environments.

Listeners can also hear Jain’s thoughts on emerging trends in PV and his insights on how PV professionals can proactively prepare for the future.

Tune in to this episode for a glimpse into the field of clinical safety and PV with Ashish Jain.

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In this episode, Ayesha spoke with Jordyn Playne, President of the Métis Nation of Ontario Youth Council, a group of youth representatives from across Ontario who advocate on behalf of the concerns and interests of Métis youth at the provincial level.

Jordyn is also a Clinical Consultant and Trainer at Waypoint Centre for Mental Health Care, as well as an advocate for cancer prevention. Jordyn has a Master’s degree in social work and licenses/certifications in cognitive behavioral therapy.

To mark Cancer Prevention Action Week, which took place during the third week of February, Jordyn also shared a personal story to help raise awareness about the importance of cancer prevention, particularly among Indigenous communities like the Métis.

Cancer is a significant concern among Métis people, including women, as they face higher cancer rates than the non-Indigenous population. Jordyn describes herself as a cancer “previvor,” as she took preventative action to reduce her risk of breast cancer.

Tune into the episode to learn more about Jordyn’s story and her work in helping to improve health awareness and health outcomes among Métis youth and the greater Métis Nation.

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In this episode, Ayesha spoke with H. B. Pierre Simon Jr., MBA, Vice President, Global Head of Marketing, Sight Sciences, about the evolving field of eye care. Sight Sciences is focused on developing and commercializing innovative solutions for eye diseases like glaucoma and dry eye disease to transform care and improve patients’ lives.

Among some of Sight Sciences devices and technologies include the OMNI® Surgical System, a minimally invasive glaucoma surgery (MIGS) device indicated to reduce intraocular pressure in adult patients with primary open-angle glaucoma (POAG), the world’s leading cause of irreversible blindness. The company’s other notable product is the TearCare® System, which has FDA clearance for localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), the leading cause of dry eye disease.

Pierre has been in the eye care industry for almost two decades. Prior to Sight Sciences, he was at Alcon for 15 years in roles with increasing responsibility, including Senior Product Manager, Global Franchise. Pierre is also a life influencer and two-time best-selling author. His latest book is entitled ‘Down Thru Love,’ a story about the journey of a young man born with Down syndrome.

In the episode, Pierre discusses some important considerations in the development of innovative new treatments for eye conditions like glaucoma and dry eye, such as working with patients and doctors and having an awareness of both current and future needs. Hear more about Pierre’s work at Sight Sciences and also as an author and speaker.

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In this episode, Ayesha talked about Rare Disease Day 2024, a global movement held on the last day of February each year that focuses on raising awareness about rare diseases including their impact on patients’ lives. This year, Rare Disease Day falls on February 29, the rarest day in a leap year, making it even more special.

Ayesha spoke about how the Rare Disease Day campaign helps increase awareness about rare diseases, promotes research and development, supports advocacy for policies supporting patients and their families and brings together a global rare disease community.

Advancements in rare disease research are leading to innovative new treatments for various rare conditions, including genetic disorders, which make up just over 70 percent of all rare diseases.

Hear more about new rare disease drugs approved by the FDA in the past couple of years. Also hear about some of the latest trends in rare disease research, including innovative trial designs, patient-centric approaches, the use of cutting-edge technologies like AI and international collaborations.

Read the full articles here:

Rare Disease Day 2024: Highlighting Statistics and Patient Stories
New Rare Disease Drugs and Research Advancements

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This episode features an interview with Amir Reichman, CEO of Scinai Immunotherapeutics, a biopharma company focused on developing, manufacturing and commercializing cutting-edge biological treatments within the inflammation and immunology (I&I) sector, with a primary focus on addressing autoimmune and infectious diseases.

Scinai Immunotherapeutics is working on developing nanosized antibodies from alpacas, known as VHH-antibodies or NanoAbs, which show promise as improved biological therapies for various illnesses. These NanoAbs are being tailored to treat conditions with significant unmet medical requirements and promising market prospects, including psoriasis and asthma.

Prior to being appointed as Scinai’s CEO in 2021, Mr. Reichman recently held the position of Head of Global Vaccines Engineering Core Technologies and Asset Management at the GSK Vaccines headquarters in Belgium. Before that, he was the Senior Director of the Global GSK Vaccines Supply Chain. He became part of GSK in 2015 following its acquisition of Novartis Vaccines, where he had various leadership positions with growing responsibilities within the Global Vaccines Supply Chain Management team, based in Holly Springs, NC, USA.

Tune into the episode to hear more about the development of new, cutting-edge inflammation and immunology therapies. Mr. Reichman also shares insights into the most significant trends currently shaping the inflammation and immunology sector.

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This episode features an interview with Yang Liu, PhD, founder, chairman, CEO and chief scientific officer; and Abid Ansari, MBA, chief financial officer at OncoC4, a clinical-stage biopharmaceutical company focused on developing novel treatments for cancer. This includes first-in-class immunotherapy products such as novel antibodies and CAR T-cell treatments targeting CTLA-4.

OncoC4 is a spinout of OncoImmune, which was acquired by Merck in December 2020. OncoImmune was founded in 2000 based on the scientific discoveries of the company’s founders who moved their lead product from a basic concept into clinical trials for multiple indications.

Dr. Liu is recognized internationally for his research on immune recognition of cancer and activation of lymphocytes. He has received several academic and research awards including the Snyder Award for Cancer Research in 2015, and was elected to the rank of fellow at the American Association for Advancement of Science (AAAS) in 2004 for his pioneering contribution to innate immunity, T cell costimulation and cancer immunology. Prior to serving full-time as OncoC4’s CEO, Dr. Liu was a faculty member at multiple academic institutions, including New York University and the Ohio State University.

Abid Ansari is a finance executive with a more 20-year track record in the life sciences industry encompassing corporate finance, fundraising, business development and investor relations experiences for public and private life science companies. Previously, he served as CFO of Artios, a UK-based DNA damage response company where he led the company’s $153 million Series C fundraising. Earlier in his career, Abid held positions at GlaxoSmithKline (GSK) in deal finance and portfolio management.

Tune into the episode to hear more about the development of new, cutting-edge cancer treatments, including current challenges in oncology and immunotherapies. Also hear about OncoC4’s collaborations including a co-development commercialization partnership with BioNTech on its lead product and a collaboration with Merck.

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This episode features an interview with Carlos Doti, MD, Vice President, US Medical Affairs Oncology, AstraZeneca, about new breast cancer treatments.

Dr. Doti is a hematologist by training and is passionate about developing treatments that have a real impact for people living with cancer across every aspect of their disease. Dr. Doti has worked in industry for the last 14 years, including seven years at AstraZeneca in various roles, and in small markets like Argentina as well as larger global markets. Since 2022, Dr. Doti has been focusing on the US market in hematology and oncology, working in breast, lung, GI and gynecological cancers among others.

Dr. Doti has previously served in medical affairs roles at Novo Nordisk A/S and Pfizer. His work is supported by more than 70 congress presentations and several peer-reviewed publications. He has also served as an investigator in more than 25 clinical trials in hemostasis, onco-hematology and infectious disease.

Recently, AstraZeneca won approval for the company’s AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for the treatment of hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1, or PTEN). The approval of Truqap was the first-in-class approval for AstraZeneca.

Tune into the episode to hear more about the milestone approval of the new combination breast cancer treatment, which has been a much-needed treatment option for the nearly 50 percent of patients with advanced HR-positive breast cancer who have PIK3CA and AKT1 mutations or PTEN alterations, and experience resistance to first-line treatments such as endocrine therapies and CDK 4/6 inhibitors.

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This episode features an interview with Punit Dhillon, Chairman & CEO of Skye Bioscience, a pharmaceutical company developing proprietary molecules to treat diseases involving inflammatory, fibrotic and metabolic conditions. Skye Bioscience is at the forefront of exploring the endocannabinoid system for drug development.

Punit brings two decades of experience as a leader and investor within the life sciences sector. During the interview, he shared his journey leading up to his role at Skye Bioscience and how his previous experiences have shaped his vision for the company.

During the interview, Punit discussed Skye Bioscience’s mission and therapeutic approach. The company is aiming to unlock the medicinal possibilities of the endocannabinoid system for addressing diseases that lack adequate treatments for patients globally.

At the end of the interview, Punit shared some advice for those looking to venture into the biotech and pharmaceutical industry.

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In this episode, Ayesha talked about some of the trends in the life sciences to watch out for in 2024. From the increasing integration of artificial intelligence (AI) and machine learning (ML) tools in drug development to medically accurate health wearables, hear about the trends and innovations that will be shaping the life sciences this year.

Ayesha spoke to industry experts and innovators in the pharmaceutical, biotechnology and medical device spaces to learn more about these trends and more. Hear about the latest technologies and approaches that will help drive innovations in drug discovery, clinical research and medical device design this year.

Read the full article here:

Life Science Trends to Look Out for in 2024

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This episode features an interview with Ben Sexson, CFA, Co-Founder, CEO, Monogram Orthopedics at Monogram Orthopedics, a company dedicated to revolutionizing orthopedic joint replacement through surgical robotics. Monogram is focused on developing patient-optimized orthopedic implants at scale by linking 3D printing and robotics with advanced pre-operative imaging.

Ben is an engineer by training and prior to joining Monogram, he served as the Director of Business Development at Pro-Dex, an OEM manufacturer of Orthopedic Robotic End-Effectors. At Pro-Dex, Ben was responsible for the development, management and launch of a proprietary product solution, helping to negate a distribution agreement with a major strategic partner.

Monogram is working to develop tailored orthopedic solutions that can help reduce complications associated with orthopedic procedures such as knee replacement surgery. In this episode, hear about Monogram Orthopedics’ customized implants, which facilitate minimal processing and coordination time for orthopedic joint replacements, and how the company is going up against big industry names like Stryker and its market-leading Mako robot as well as Zimmer Biomet.

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This episode features an interview with Adam Kaplin, MD, PhD, Cofounder, President and Chief Scientific Officer at MIRA Pharmaceuticals, a preclinical-stage pharmaceutical company focused on the development and commercialization of new molecular synthetic cannabinoid analogs for the treatment of anxiety and cognitive decline typically associated with early-stage dementia.

Dr. Kaplin is a neuropsychiatrist whose research focuses on the investigation of the biological basis of immune-mediated depression and cognitive impairment by using multiple sclerosis as the model. Dr. Kaplin transitioned into industry by joining MIRA Pharmaceuticals to help lead drug development in the space.

Prior to joining MIRA Pharmaceuticals, Dr. Kaplin served in a number of positions at Johns Hopkins University, including Principal Neuro-Psychiatric Consultant to the Johns Hopkins Multiple Sclerosis Center of Excellence, among others. He also served as Co-Founder of numerous healthcare related startups, including, from 2018 to present, REWARD Pathways, a company devoted to addiction treatment focused on a combined eHealth and medicine approach.

Dr. Kaplin’s original research has been published over 70 times in peer-reviewed publications in key areas in neuroscience and immunology, with a particular focus on the intersection of neurology and psychiatry.

In this episode, hear about drug development for conditions like dementia, cognitive decline and anxiety, and how MIRA Pharmaceuticals’ synthetic cannabinoid-based drug candidate could serve as a significant treatment advancement for these conditions.

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This episode features an interview with vaccine scientists and executives from Vaccines Global Clinical Development at Merck, Dr. Heather Platt, MD, Distinguished Scientist and Pneumococcal Vaccine Lead; and Dr. Ulrike Buchwald, MD, Scientific Associate Vice President, Global Clinical Research and Pneumococcal Vaccine Section Head.

Over the past ten years, Dr. Platt has worked across both infectious disease and vaccines products in both early- and late-stage clinical research. In her current role at Merck, she leads the product development team for V116, an investigational pneumococcal conjugate vaccine. Dr. Platt completed her training in Internal Medicine at Rutgers/Robert Wood Johnson Medical School, and Infectious Diseases Fellowship at New York Presbyterian/Columbia University Medical Center.

Dr. Buchwald applies her experience in public health and basic science research to expand Merck’s pneumococcal vaccine franchise and the development of next generation adult and pediatric pneumococcal conjugate vaccines. Since 2017, Dr. Buchwald has focused on pneumococcal disease prevention in various roles at Merck. Dr. Buchwald received her MD and Dr. med degree from the Freie University in Berlin, Germany, and completed her Internal Medicine residency and Infectious Diseases fellowship at New York University. She continues to see patients at Johns Hopkins University.

Merck recently announced results from STRIDE-3, a Phase III trial evaluating the immunogenicity, tolerability and safety of V116, the company’s investigational 21-valent pneumococcal conjugate vaccine, which is specifically designed for the protection of adults against pneumococcal infection.

In this episode, hear more about V116, pneumococcal infection, Merck’s vaccine development program and the company’s approach to addressing the specific needs of different populations, including infants and children, adults and at-risk subgroups.

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This episode features an interview with Fady Boctor, MBA, President and Chief Commercial Officer at Petros Pharmaceuticals, a Men’s Health pharmaceutical company that aims to develop complementary therapeutics designed for a man’s journey. The company focuses on therapeutics that promote medication adherence, tolerability and preservation of male organic function.

Fady has over 20 years of experience in the pharmaceutical industry, and has worked for companies such as Novartis, Forest Pharmaceuticals, Auxilium Pharmaceuticals, Endo Pharmaceuticals and Adapt Pharmaceuticals (Emergent Biosolutions).

In the episode, Fady discussed Petros Pharma’s lead ED therapeutic and its potential to be transitioned to OTC status. He also discussed the overarching challenges in men’s health today and how Petros is positioned to tackle them.

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This episode features an interview with Wa'el Hashad, CEO of Longeveron.

Hashad discussed Longeveron’s mission and the therapeutic areas the company is investigating. He discussed the mechanism of action of the company’s lead program, Lomecel-B.

Lomecel-B is an “allogeneic” (donor-derived) cell therapy product. Lomecel-B is a cellular therapy currently under clinical investigation as a potential treatment for various aging-related chronic diseases and life-threatening conditions. These studies are conducted under the approval of the FDA’s Investigational New Drug (IND) Applications.

Lomecel-B is under clinical investigation for pediatric hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and aging frailty.

Longeveron is based in Miami, Florida, with its corporate headquarters and manufacturing operations situated in the Converge Miami Building.

Hashad also shared the next steps for Longeveron’s programs.

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This episode features an interview with Attorney Temitope (Tope) Leyimu, a toxic exposure attorney at Motley Rice  who is leading a lawsuit over hair relaxing products that contain harmful chemicals.
 
Hair relaxing products are used for straightening/smoothening hair and many contain harmful formaldehyde, formaldehyde-releasing and other toxic chemicals. The FDA recently issued a recommendation for the recall of chemical hair relaxers containing harmful chemicals. While the agency has initiated its rule-making process, a ban hasn’t been implemented yet.

The products, which have historically been targeted primarily at black and brown women of African descent, have drawn major concern due to their links with reproductive-related cancers such as ovarian, cervical and uterine cancer. An October 2022 study by the National Institutes of Health, revealed that women using chemical straighteners face a 150 percent increased risk of uterine cancer.

Attorneys leading the hair relaxer lawsuit including Leyimu say the FDA proposal is a significant step in advancing public health for women, particularly black and brown women, who are disproportionately impacted by many of these products that are alleged to be harmful.

Tune into the episode to learn more about the litigation, including the historic racialized marketing of harmful hair relaxing products to women of African descent in the US.

If you or anyone you know may have been affected by these products, you can complete the webform to contact Motley Rice if you would like to talk to someone about the lawsuit.

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This episode features an interview with Dr. Lahar Mehta, Head of Global Clinical Development at Amylyx Pharmaceuticals, who spoke to Xtalks about Amylyx’s clinical trial design of ORION, a Phase III Global Study of AMX0035 (Relyvrio) in Progressive Supranuclear Palsy (PSP).

The company presented details about the trial at the Neuro2023 PSP and CBD International Research Symposium that took place in London last month in October. The ORION study will evaluate the safety, efficacy, and tolerability of AMX0035 in PSP patients. The drug was approved by the FDA last year for the treatment of ALS.

PSP is a rare, progressive, adult-onset neurological disorder that affects body movements, walking and balance, eye movement, swallowing, and speech. There are currently no approved medicines to treat PSP.

Hear more about the details of the trial, which is set to begin in December this year.

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In this episode, Ayesha talked about the FDA’s acceptance of AstraZeneca’s supplemental biologics license application (sBLA) for a self-administered option of its nasal influenza vaccine FluMist Quadrivalent. While FluMist has been in the market since 2003, AstraZeneca is now seeking FDA authorization for a self-administered option of the vaccine. By offering a more accessible and flexible self-administered option, the company and experts in the field hope it will help increase uptake of the flu vaccine, especially as flu vaccinations have been on the decline in recent years.

Ayesha and the editorial team also talked about a new ad from GSK Canada that features Wayne Gretzky, as well as a younger, AI-generated Gretzky, raising awareness about RSV vaccination among older adults. The ad features young Gretzky reminding his older self to get his RSV vaccine as older adults are at a greater risk of developing complications from RSV infection. Hear more about the ad featuring the Canadian hockey icon.

Read the full articles here:

FluMist Nasal Flu Vaccine Gets FDA Consideration for Self-Administration
GSK Canada’s New RSV Vaccine Ad Features Wayne Gretzky, Young and Old

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Visit clinicaledge.xtalks.com/issue1 to dive into the first issue of Xtalks Clinical Edge magazine and be a part of the conversation shaping the next era of clinical trials. Xtalks Clinical Edge — "where innovation meets expertise!"

This episode features an interview with Dr. Stephanie Manson Brown, VP & Head of Clinical Development & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. Allergan Aesthetics is focused on creating products and technologies that drive the advancement of aesthetic medicine.

Dr. Manson Brown’s Clinical Development and Scientific Innovation team are responsible for global clinical trial development strategy for the Aesthetic Medicine portfolio, covering pharmaceuticals and device. Dr. Brown is co-chair of the Aesthetics Pharmaceutical Governance Board at AbbVie and is the co-founder of the Science of Aging. She was honored as a 2023 Healthcare Business Women’s (HBA) Luminary. Prior to joining industry, Dr. Manson Brown was trained to be a Plastic Surgeon and is a board-certified surgeon (MRCS).

Dr. Manson Brown spoke about the innovations in the medical aesthetics space, including breast reconstruction for breast cancer patients. She spoke about clinical trials in the space, including Allergan Aesthetics' commitment to increasing diversity in trials and developing products that do not cater to any one beauty standard.

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This episode features an interview with Dr. Genevieve Neal-Perry, MD, PhD, professor and chair at the UNC School of Medicine Department of Obstetrics and Gynecology, and lead investigator on a study investigating Astellas Pharma’s fezolinetant (Veozah), which received FDA approval in May this year for the treatment of moderate to severe vasomotor symptoms due to menopause.

It’s the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat vasomotor symptoms, which include hot flashes and night sweats, associated with menopause.

Dr. Neal-Perry spoke about some of the latest trial data for fezolinetant that was presented at the recent Annual Meeting of The Menopause Society. This includes the effect of the drug on moderate-to-severe vasomotor symptoms in subgroups based on hormone therapy history from pooled data from two randomized Phase III studies. It also included safety data over a period of 52 weeks from three randomized Phase III studies (SKYLIGHT 1, 2 and 4).

It is estimated that around 60 to 80 percent of women experience vasomotor symptoms during or after the menopausal transition. They can have a significant impact on daily activities and overall quality of life.

Tune into the episode to hear from Dr. Neal-Perry about vasomotor symptoms associated with menopause and the new trial data for fezolinetant.

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In this episode, Ayesha talked about a lawsuit that Johnson & Johnson and IBM are facing over a data breach that occurred at Janssen’s CarePath, Johnson & Johnson’s patient assistance program, the portal for which is run by IBM. The lawsuit was filed with the federal court in the Southern District of New York by a Florida resident who claims the companies failed to adequately protect patients’ personal identity and health information as per the Health Insurance Portability and Accountability Act. Hear more about the data breach and the risk and repercussions of cyberattacks in pharma and healthcare.

Ayesha also talked about a new contactless, at home sleep monitoring device that measures vital signs which received clearance from the FDA. The device, developed by Zürich-based med tech startup Sleepiz AG and called Sleepiz One+, offers short- and long-term monitoring of heart rate and respiration during sleep to provide insights into a patient’s physiological status. The company says the device helps monitor disease progression or remission and also helps in the diagnosis of sleep disorders such as sleep apnea. Hear more about the device in this episode.

Read the full articles here:

Johnson & Johnson and IBM Hit with Class Action Lawsuit Over Patient Data Breach

Sleepiz’s At Home Sleep Monitoring Device Wins FDA Clearance

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This episode features an interview with Dr. Paul Rennert, co-founder, CEO and CSO of Aleta Biotherapeutics, an immuno-oncology company focused on multi-antigen targeting solutions designed to enhance the action of CAR T cell therapies in B cell lymphoma, B cell leukemia and multiple myeloma, as well as non-B cell cancers such as acute myeloid leukemia (AML) and solid tumors such as breast cancer, gastric cancer and pediatric brain tumors.

Dr. Rennert spoke to Xtalks about CAR T cell engagers that Aleta is developing for both B-cell and non-B cell cancers. The company was recently granted clinical trial authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its investigational biologic CAR T-Cell engager ALETA-001. It will be evaluated in a Phase 1/2 clinical trial for the treatment of patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T-cell therapy. 

Dr. Paul Rennert is a noted research scientist and biotechnology executive with extensive strategic and leadership experience. After launching successful new biotech companies from 2012 to 2016, he co-founded Aleta Biotherapeutics. Dr. Rennet’s ability to work broadly across the industry grew from his outstanding early career at Repligen and Biogen, highlighted by multiple successful drug-development campaigns, over 50 patents filed and granted, and approximately 100 peer-reviewed publications.

Tune into the episode to hear more about Dr. Rennert’s work in advancing CAR T cell therapies in oncology.

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This episode features an interview with Dr. Elmar Joura, Associate Professor of Gynecology in the Department of Obstetrics and Gynecology at the Medical University of Vienna, who spoke to Xtalks about exciting new long-term Gardasil vaccine data from a study he led as principal investigator that showed the long-term impact of HPV vaccination.

Merck recently announced new, 10-year long-term follow-up data published in the journal, Pediatrics, for girls and boys who received a three-dose regimen of the HPV vaccine Gardasil 9 at the ages of nine to 15 years old.

Immunogenicity data from the study showed sustained HPV-antibody responses ten years after administration of the third dose in both boys and girls. Results also showed no cases of certain HPV-related high-grade disease or certain studied cancers or genital warts. Additionally, no GARDASIL 9-related serious adverse events or deaths were reported.

HPV-related cancers and diseases remain a significant public health issue with the CDC estimating that tens of thousands of people were diagnosed with certain HPV-related cancers each year from 2015 to 2019.

Hear more about the new long-term HPV vaccine data and the importance of increasing vaccine coverage, particularly in the developing world, in the prevention of HPV-related cancers.

For more life science and medical device content, visit the Xtalks Vitals homepage.

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In this episode, Vera interviews Dr. Kristin Yarema, President of Cell Therapy at Poseida Therapeutics, about Poseida’s cell therapy approach and technologies.

In April 2023, Dr. Yarema became the President of Cell Therapy at Poseida. She brings a wealth of knowledge from the biopharmaceutical realm, with expertise in oncology and allogeneic T-cell immunotherapy.

Poseida is a clinical-stage biopharmaceutical firm that utilizes its unique non-viral gene engineering methods to develop innovative cell and gene therapies. With their extensive genetic engineering capabilities, they are paving the way for potentially better and safer treatments for conditions including blood cancers such as multiple myeloma, solid tumors like breast and ovarian cancer, and rare genetic liver diseases.

In this episode, Dr. Yarema talks about the advantages of “off the shelf” or allogeneic CAR-T cell therapy vs. autologous cell therapy — and what makes Poseida’s approach unique.

Dr. Yarema discusses Poseida’s two Phase I programs in collaboration with Roche, highlighting the strategic partnership's significance for Poseida.

She shares what Poseida is looking forward to with the Investigational New Drug (IND) clearance for the first dual CAR program targeting CD19 and CD20 for the treatment of B-cell malignancies.

Dr. Yarema also discusses how the recent $50 million strategic investment from Astellas Pharma in Poseida signifies a notable endorsement and potential growth trajectory for the company.

The episode concludes with Dr. Yarema sharing her thoughts about the promise of allogeneic CAR-T cell therapy for patients.

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This episode features an interview with Dr. Tania Kamphaus and Tony Villiotti about new research on the utility and promise of blood-based biomarker tests for the diagnosis of liver diseases like non-alcoholic steatohepatitis (NASH).

The research is particularly timely because the American Diabetes Association (ADA) recently called for liver disease screening for all adults with type 2 diabetes.

The research, published in Nature Medicine, presents results from a study that evaluated blood-based biomarker tests for the diagnosis of NASH.

The study’s co-author, Dr. Tania Kamphaus, Director of Translational Science, Metabolic Disorders, as well as Director of Patient Engagement, at the Foundation for the National Institutes of Health (FNIH), shared results from the study in this podcast episode. She discussed the potential of non-invasive tests to become the standard of care for liver disease diagnosis and the ongoing work her group is doing in this area.

Tony Villiotti is the founder of the nonprofit, NASH Knowledge, and a patient whose NASH led to liver cancer and subsequent liver transplant. He spoke about the impact this research will have on the patient community. Tony believes that his liver cancer could have been prevented had a non-invasive test for NASH been available to him.

Hear more about Dr. Kamphaus' group’s research in liver disease and Tony’s patient advocacy work to help improve awareness around NASH and help bring new diagnostics and treatments to light.

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This episode features an interview with Ram Mukunda and Claudia Grimaldi from IGC Pharma, a clinical-stage pharmaceutical company focused on improving the health and well-being of patients affected by Alzheimer’s disease and bringing therapies for it to market.

The company is currently conducting a Phase II study with IGC-AD1, an investigational low-dose tetrahydrocannabinol-(THC) based formulation that reduces neuropsychiatric symptoms such as agitation in dementia due to Alzheimer’s. The drug is the only natural THC-based investigational drug undergoing FDA trials. Ram and Claudia spoke about the compound, including clinical data from the ongoing trials evaluating it.

Ram Mukunda is the founder and CEO of IGC Pharma. Previously, he served as Chairman and CEO of Startec Global Communications Corp., Council Member at Harvard Kennedy School of Government and Council Member at Belfer Center for Science & International Affairs. Ram Mukunda has an undergraduate and a graduate degree in biomedical engineering from the University of Maryland.

Claudia Grimaldi is currently Vice President, Principal Finance Officer, and Chief Compliance Officer at IGC. She has been with the company for almost 12 years with increasing responsibilities including managing SEC and NYSE filings, regulatory compliance and disclosures. She is also the Managing Director of IGC Pharma Columbia, a director of the company’s subsidiary in India and a director of the board at IGC. Ms. Grimaldi is a psychologist by training, is certified as a public director by the NACD and has an MBA from Meredith College in North Carolina.

Tune into this episode to hear from the team at IGC about the company’s commitment to discovering new treatments for Alzheimer’s to help improve the lives of patients and their caregivers.

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This episode features an interview with Dr. David Young, founder and President R&D at Processa Pharmaceuticals, a clinical-stage pharmaceutical company developing personalized approaches to cancer treatments with a focus on next generation chemotherapy drugs with improved safety and efficacy. Processa recently released an update on its clinical cancer program, which Dr. Young discussed with Xtalks in this podcast episode.

Dr. Young is Processa’s initial founder, President of R&D and former President and CEO. He has over 30 years of pharmaceutical research, drug development and corporate experience. He served on the Board of Directors and as Chief Scientific Officer of Questcor Pharmaceuticals from 2009 to 2014. He has also served on FDA Advisory Committees and has been a key team member on more than 30 NDA/supplemental NDA approvals. Dr. Young received his Pharm D-PhD with emphasis in Pharmacokinetics and Pharmaceutical Sciences from the University of Southern California.

Tune into this episode to hear from Dr. Young about Processa’s developmental pipeline and the promise of personalized, next generation chemotherapies. Learn about Processa’s regulatory science approach to drug development and the changing landscape of cancer treatment.

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In this episode, Ayesha talked about how three more US states have filed a lawsuit against Eli Lilly over its proposed $13.5 million insulin pricing settlement. The states join six others who have been fighting Eli Lilly in court since 2017, claiming that the company hiked prices of its insulin product Humalog. The states say the $13.5 million settlement offer from Eli Lilly doesn’t come close to the $1 billion worth of claims the company is facing. Hear more about the insulin pricing controversy in this episode.

Ayesha also talked about the FDA approval of Regeneron’s high dose Eylea (HD Eylea) for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). Hear about how high dose Eylea offers less frequent dosing regiments, and how it will be facing Roche’s blockbuster eye injection Vabysmo.

Read the full articles here:

More US States Take on Eli Lilly in Court Over Proposed $13.5 Million Insulin Pricing Settlement

Regeneron’s High Dose Eylea Gets FDA Nod for Wet AMD and DME

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This episode features an interview with Dr. William Williams, CEO of Briacell Therapeutics, a biotech company based in Philadelphia that is dedicated to developing novel immunotherapies to fight cancer and improve patient lives.

Dr. Williams is a seasoned biopharmaceutical executive with over 35 years of industry and academic expertise, including significant clinical management in multinational pharmaceutical companies like Incyte Corporation and GlaxoSmithKline. Dr. Williams has facilitated the entry of over 20 compounds into the clinic, including approvals for ruxolitinib (Jakafi) and baricitinib (Olumiant).

BriaCell is developing cell therapies for the treatment of advanced breast cancer and has promising compounds, including Bria-IMT, that are currently being evaluated in clinical trials. BriaCell recently received FDA approval for its Bria-IMT Combination pivotal study design in advanced metastatic breast cancer.

Tune into this episode to hear from Dr. Williams about BriaCell’s novel cell therapies for cancer and what the future of immunotherapy and personalized treatments may look like.

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In this episode, Ayesha talked about the FDA approval of Zurzuvae (zuranolone) the first oral tablet for the treatment of postpartum depression (PPD). While the approval is a major win in PPD, as current treatments involve administration by infusion or use of general antidepressants, Zurzuvae developers Biogen and Sage Biotech were banking on getting approval for it in major depressive disorder (MDD). However, the FDA rejected it in MDD and only handed the approval in PPD. Hear more about the drug and the approval/rejection in this episode.

Ayesha also talked about Johnson & Johnson’s latest bankruptcy attempt related to its talc baby powder cases that was shot down by a US Bankruptcy Court. The company said it will appeal the decision as it continues to offer talc claimants a $8.9 billion settlement, which it says is the best way to resolve the cases in a timely and financially equitable manner. This is the company’s second bankruptcy attempt, both of which have been turned down so far. Listen to the full episode to learn more about Johnson & Johnson’s ongoing legal saga.

Read the full articles here:

Zurzuvae Earns Win for Postpartum Depression, Faces Challenges in MDDTalc Litigation Saga Continues: Court Rejects J&J’s Latest Bankruptcy Attempt

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In this episode, Ayesha talked about the FDA clearance of the world’s smallest insulin pump from Tandem Diabetes Care. The insulin pump, called the Tandem Mobi, features an automated insulin delivery system with options for manual delivery as well. The device is small enough to fit into the coin pocket of a pair of jeans and offers several wearable options. It can be operated through an app and also features technology compatible with continuous glucose monitoring systems. 

Ayesha and the team also discussed the FDA clearance of the first FDA cleared NMR-based test from Numares Health. The company’s AXINON test system measures levels of low density lipoprotein particle (LDL-p), which the company touts as being a more robust biomarker than LDL-cholesterol (LDL-c) for evaluating cardiovascular disease risk. Hear more about the test, including some of its other disease applications, in this episode.  

Read the full articles here:

Tandem Mobi Becomes World’s Smallest Insulin Pump with FDA Clearance

New Cardiac Biomarker Test Gets FDA Clearance

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This episode features an interview with Dr. Lawrence Eichenfield, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego, and professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine. 

Dr. Eichenfield serves on Verrica Pharmaceuticals’ Board of Directors and spoke to Xtalks about the company’s recent approval of YCANTH (cantharidin) topical solution as the first FDA approved treatment for pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection that primarily affects children. Dr. Eichenfield was also the principal investigator on clinical trials evaluating YCANTH.

Verrica Pharmaceuticals is a dermatology therapeutics company developing medications for skin diseases that require medical interventions. 

Tune into this episode to learn more about YCANTH and its approval, as well as the changing landscape of dermatology, from Dr. Eichenfield.

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This episode features an interview with Jeremy Stackawitz, CEO at Senzo, a London-based MedTech company that has developed a new lateral flow technology for infectious diseases with the same accuracy as central labs testing.

Jeremy, who was formerly at companies like Quotient and Johnson & Johnson, discussed how the development of this technology can unlock new models of care such as personalized, preventative and remote healthcare.

Senzo’s products and systems bring testing to the patient, allowing for the generation of results that are as accurate as traditional central-lab testing, but faster and at the point-of-care. Senzo says it has started off by targeting diseases with some of the highest global impacts, such as TB, HIV, Flu, Covid, Hep-C and C. diff and plans to move to other viruses and biomarkers.

Hear more about how Senzo is working towards its goal to make lab testing accuracy readily available at the point-of-care, real-time, accessible and affordable. Insights generated at the point-of-care will allow patients and healthcare professionals to make better and faster decisions, improving treatment outcomes and saving lives.

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Uptake of biosimilars is lagging in the US, but why? In this episode, Sarah interviews Juliana M. Reed, Executive Director of the Biosimilars Forum, to find out the real barriers to widespread access to biosimilars, and how these problems could be addressed.

Julie discusses the role of pharmacy benefit managers (PBMs) and the incentives that keep them from listing most biosimilars on their formularies. She applauds the recent launch of multiple new biosimilars for the blockbuster biologic Humira and explains why this moment is pivotal for the biosimilars industry and the US healthcare system as a whole. 

Mentioned during this episode:

Interview with Dr. Gillian Woollett, VP, Head of Regulatory Strategy and Policy at Samsung Bioepis – Xtalks Life Science Podcast Ep. 110

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In this episode, Sarah interviews Dr. Joshua Cohen, Chief Medical Officer at Braeburn, who talks about the stigma associated with opioid use disorder (OUD), and how our treatment of this condition is changing.

Dr. Cohen talks about the recent FDA approval of Brixadi, the first long-acting buprenorphine treatment for opioid use disorder that has both weekly and monthly dosing options, and explains the technology behind its extended-release formula.

Read the full article here:

Brixadi Is a New Long-Acting Buprenorphine Treatment Against OUD 

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In this episode, Vera interviews two experts from CytoMed Therapeutics: Mr. Choo Chee Kong, Chairman and Director; and Dr. Tan Wee Kiat, PhD, Chief Operating Officer.

Established in 2018, CytoMed is a biotechnology firm that originated from the Agency for Science, Technology and Research (A*STAR), Singapore's premier public sector research and development agency. The goal of CytoMed is to develop efficient and cost-effective cellular immunotherapy solutions for solid tumors and hematologic cancers.

On April 14, 2023, CytoMed’s shares began trading on the Nasdaq Capital Market under the ticker symbol "GDTC".

In this episode, Mr. Choo and Dr. Tan share insights about how CytoMed Therapeutics is aiming to engineer more affordable cellular cancer therapies. Dr. Tan discusses the advantages of “off-the-shelf” cell-based cancer immunotherapies. Mr. Choo describes the cellular therapies that are currently in CytoMed’s pipeline. 

The episode concludes with Mr. Choo and Dr. Tan sharing their thoughts about how the company’s initial public offering (IPO) will help them in their mission of developing off-the-shelf cell-based cancer immunotherapies.

Read the full article that mentions CytoMed Therapeutics here:

Biotech IPOs in 2023: Shaping the Future of Innovation

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This episode features an interview with Marci English, Vice President and Head of BioPharma Development at Astellas Pharma, about the recent FDA approval of the company’s drug Veozah (fezolinetant) for the treatment of moderate to severe hot flashes and night sweats due to menopause. 

Hormone replacement therapy (HRT) has been the conventional treatment for menopause-associated vasomotor symptoms, otherwise known as hot flashes and night sweats; however, not all women can receive hormone therapies. Apart from HRT, treatment options have been limited for the vasomotor symptoms of menopause and therefore, the approval of Veozah addresses a significant unmet need in the space. 

Hear more about Veozah, including its mechanism of action and the pathways to its approval.

Read more at: Veozah (Fezolinetant) Is a New Type of Drug for Menopausal Hot Flashes

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In this episode, Vera interviews Dr. Grayson Zulauf, CEO and Co-Founder of Resonant Link, about the state of wireless charging for medical device implants today. Dr. Zulauf shares why improvements are needed for faster wireless charging.  

Dr. Zulauf also shared insights into Resonant Link’s latest and the world’s fastest charger for titanium can-based medical device implants. He discussed the impact of this charger on patient care and quality of life. In addition, Vera and Dr. Zulauf discussed the work Resonant Link is doing in other industries, such as electric vehicles and consumer electronics. The episode concluded with Dr. Lulauf sharing what’s next for Resonant Link.

Read the full article here:

Resonant Link Develops Fastest Wireless Charger for Implantable Devices

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This episode features an interview with Dr. Courtney Silverthorn who is an Associate Vice President at the Foundation for the National Institutes of Health (FNIH) and the Director of the Accelerating Medicines Partnership (AMP) program including the Bespoke Gene Therapy Consortium. 

The FNIH recently announced that the AMP Bespoke Gene Therapy Consortium has selected eight rare diseases for its clinical trial portfolio. Xtalks spoke with Dr. Silverthorm about the consortium’s new rare disease clinical trial portfolio.

Hear more about the diseases that were selected and the consortium’s goal of accelerating the path of new therapies for rare diseases to clinical trials.

The Bespoke Gene Therapy Consortium was jointly launched by the NIH and US Food and Drug Administration (FDA) in 2021 to help address common issues that gene therapy developers face. It included formulating a standardized therapeutic development model that would help accelerate clinical trial processes for new treatments.

Read more at: Bespoke Gene Therapy Consortium Selects 8 Rare Diseases for Clinical Trial Portfolio

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In this episode, Vera interviews Carm Huntress, CEO and Founder of Credo Health, about the challenges that the US healthcare industry is facing today with medical record management. Carm discusses why medical records should be digitized and the improvements needed for the retrieval and analysis of digital medical records.

Vera and Carm also discussed how Credo Health’s new AI platform for medical records, PreDX, works and how it makes the tasks of healthcare providers easier. Carm also shared his thoughts about privacy concerns regarding the use of AI to scan medical records. The episode concluded with Carm sharing what’s next for Credo Health.

Read the full article here:

Advancing Medical Record Management: The Power of AI/ChatGPT

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In this episode, Ayesha talked about the FDA approval of the first topical gene therapy for the treatment of a rare skin condition. Krystal Biotech’s Vyjuvek is a topical gene therapy that has been approved for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB). It’s the first treatment for the rare disease. Hear more about DEB and Vyjuvek in this episode.

Ayesha and the team also discussed the FDA approval of Bausch + Lomb’s first prescription drug for the treatment of dry eye disease. The drug, called Miebo, is also the first treatment that targets tear evaporation, which is a leading cause of dry eye disease. Hear more about the drug and its approval in the show.

Read the full articles here:

Vyjuvek Gets FDA Nod as First Topical Gene Therapy for Rare Skin Disease

Miebo Approved as First Dry Eye Disease Treatment to Target Tear Evaporation

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In this episode, Vera talked about the US Food and Drug Administration’s (FDA) approval of Veozah (fezolinetant), the new type of drug for menopausal hot flashes and night sweats. It is estimated that around 60 to 80 percent of women experience vasomotor symptoms (hot flashes, night sweats, etc.) during or after the menopausal transition. Importantly, vasomotor symptoms can have a substantial impact on daily activities and overall quality of life. The team discussed Veozah and the benefits of this drug for women’s health.

Vera and the team also discussed the recent FDA approval of Allergan Aesthetics’ new hyaluronic acid product, SkinVive by Juvéderm, for achieving skin smoothness. SkinVive will be the first and only intradermal microdroplet injection of hyaluronic acid available in the US, representing a significant milestone in skincare innovation. The team discussed the benefits and novelty of the product, as well as their personal opinions of hyaluronic acid products for skincare and the costs of such treatments.  

Read the full articles here:

Veozah (Fezolinetant) Is a New Type of Drug for Menopausal Hot Flashes

SkinVive by Juvéderm: The New Dermal Filler Coming to the US

See the related webinars here:

Hot Flashes, Brain Fog and the Blues: Frontiers in Menopause Treatments

Innovations in Skin Care Ingredients: Beauty from Within, Wellness Throughout

For more life science and medical device content, visit the Xtalks Vitals homepage.

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In this episode, Sarah interviews Dr. Gillian Woollett, VP, Head of Regulatory Strategy and Policy at Samsung Bioepis, about the challenges of bring biosimilars to market. Dr. Woollett clears up some common misconceptions about achieving interchangeable status and addresses the issues with differences in global regulatory standards for biologics medicines. 

Sarah and Dr. Woollett also discuss Samsung Bioepis’ first US Biosimilar Market Report (linked below) and some of its key findings on biosimilar cost savings, uptake and market share. She also shares the way forward to help biosimilars see broader use both in the US and Europe.

Read about the publications mentioned in this episode here:

Samsung Bioepis’ First US Biosimilar Market Report

A 'Global Reference' Comparator for Biosimilar Development

An Efficient Development Paradigm for Biosimilars

Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance

Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One

The Role of PD Biomarkers in Biosimilar Development - To Get the Right Answer One Must First Ask the Right Question

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In this episode, Ayesha talked about the FDA approval of the world’s first vaccine for respiratory syncytial virus (RSV). The vaccine is approved for adults 60 years of age and older. RSV is a respiratory virus that causes mild to moderate cold and flu-like symptoms, but it can cause complications like lower respiratory tract disease (LRTD) and pneumonia in older adults and young children. Read more about the vaccine, including clinical trial results on its efficacy and safety. 

Ayesha and the team also discussed the FDA approval of Qalsody (tofersen), a novel, first-of-its-kind treatment for ALS. The treatment, an antisense oligonucleotide developed by Biogen, targets abnormal proteins arising from SOD1 mutations, which are associated with the development of ALS in some patients. Even though these mutations only account for two percent of ALS cases worldwide, the treatment is an important milestone that sets the stage for the development of more ALS therapies.

Read the full articles here:

Arexvy Becomes World’s First RSV Vaccine

Qalsody (Tofersen) Becomes First-of-Its-Kind Treatment for ALS

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In this episode, Vera talked about how a couple of direct-to-consumer TV commercials have helped a medical device company, Axonics, establish its reputation in the non-drug incontinence therapy space. Around 87 million adults in the US and Europe have overactive bladder and it is estimated that an additional 40 million adults have fecal incontinence. Axonics offers innovative sacral neuromodulation (SNM) systems that are approved by the US Food and Drug Administration (FDA) for the treatment of bladder and bowel dysfunction. The team discussed Axonics Therapy and the occurrence of non-drug (medical device) TV ads.

Vera and the team also discussed how two companies, Cerner Enviza and John Snow Labs, are teaming up with the FDA to use AI tools to better understand the side effects of drugs. This project is part of the FDA’s Sentinel Initiative to evaluate the effects of medicines on real-world populations. Hear more about how Cerner Enviza and John Snow Labs will use AI to explore the mental health side effects of a commonly prescribed asthma drug, Singulair (montelukast)

Read the full articles here:

Axonics Touts Non-Drug Incontinence Therapy in TV Ads

How Cerner Enviza Will Use AI To Study the Mental Health Side Effects of Montelukast

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This episode features an interview with Cody Simmons, CEO of DermaSensor, a health technology company that aims to launch the world’s first point-and-click skin cancer detection tool for primary care providers.

The skin cancer evaluation tool, also called DermaSensor*, is a point-and-click device that can provide health care practitioners with a skin evaluation in seconds. 

As a bioengineer and entrepreneur, Cody has spent all of his career bringing new health technologies to physicians and patients. Prior to joining DermaSensor, Cody led commercial efforts for a Silicon Valley medical device screening and monitoring startup. He began his career in business development and commercial strategy roles at Genentech.

Hear more about the innovative technology and application of DermaSensor in this episode. And view a video excerpt of the device in action here: https://youtu.be/4-NnRcyOFHc

Read more at: Clinical Studies Support DermaSensor’s Skin Cancer Detection Device

*FDA submission pending review. DermaSensor is currently not for sale in the United States.

References

1. Merry SP, Croghan I, McCormick B, Chatha K, Leffell D. Clinical Performance of Novel Elastic Scattering Spectroscopy (ESS) in Detection of Skin Cancer: A Blinded, Prospective, Multi-Center Clinical Trial [Initial Results]. Poster Presentation, Innovations in Dermatology Conference, Las Vegas, NV, November 3-5, 2022.

2. Carli P, Nardini P, Crocetti E, De Giorgi V, Giannotti B. Frequency and characteristics of melanomas missed at a pigmented lesion clinic: a registry-based study. Melanoma Res 2004;14(5):403-407.

3. Soyer H, Argenziano G, Zalaudek I, Corona R, Sera F, Talamini R, et al. Three-point checklist of dermoscopy. A new screening method for early detection of melanoma. Dermatology. 2004;208:27-31.

4. Stanganelli I, Serafini M, Bucch L. A cancer-registry-assisted evaluation of the accuracy of digital epiluminescence microscopy associated with clinical examination of pigmented skin lesions. Dermatology. 2000;200(1):11-16.

5. Dinnes J, Deeks JJ, Grainge MJ, et al. Visual inspection for diagnosing cutaneous melanoma in adults. Cochrane Database of Systematic Reviews. 2018;12:CD013194.

6. Data on File, DermaSensor Inc.

7. Seiverling EV, Agresta T, Cyr P, Caines L, Nguyen VL, Chatha K, Siegel DM. Clinical Utility of an Elastic Scattering Spectroscopy Device in Assisting Primary Care Physician’s Detection of Skin Cancers. Poster Presentation, Maui Derm Hawaii Conference, Wailea, HI, January 24-28, 2023.

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In this episode, Ayesha talked about new rules that the US Environmental Protection Agency (EPA is proposing for curbing ethylene oxide emissions from sterilization facilities. The agency says the new guidelines would help reduce emissions by 80 percent, which is particularly important for communities that live near sterilization plants and workers who work at them. Ethylene oxide is a known carcinogenic, with long-term exposure to the odorless, colorless gas being associated with cancers including breast cancer and myeloma among others. The gas is used to sterilize medical equipment as well as spices. Hear about the new proposed rules and industry reactions to them.

Ayesha and the team also discussed Johnson & Johnson’s latest offer of $8.9 billion to settle the mountain of talc lawsuits it continues to face. The claimants maintain that the company’s talc-based baby powder had high amounts of asbestos contamination, which the company has known about since the 1970s. One plaintiff group has said Johnson & Johnson’s latest offer is not enough and criticized the company’s strategic bankruptcy plans. A US Court of Appeals rejected the plan earlier this month but Johnson & Johnson said it will take its case to Supreme Court. Hear more about the company’s latest settlement offer in this episode.

Read the full articles here:
EPA Wants Tougher Restrictions on Ethylene Oxide Emissions from Sterilization Facilities
Johnson & Johnson Offers $8.9 Billion in Talc Lawsuits But Not Enough Says a Plaintiff Group

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This episode features an interview with Wei-Li Shao, President of Omada Health.

Omada Health is a provider of virtual care solutions focused on common chronic conditions, including both type 1 and type 2 diabetes, hypertension and musculoskeletal. As a virtual-first chronic care provider, the company helps members make lasting changes to improve health and reduce care costs for organizations.

Wei-Li is a global executive leader with over 20 years of experience building and leading biopharmaceutical and diagnostic imaging businesses in the United States, New Zealand, China and Taiwan. He joined Omada Health in 2019 following an 18-year career as an executive at Eli Lilly and Company.

Hear more about Omada Health and its commitment to quality virtual care in this episode.

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In this episode, Xtalks’ senior editorial staff discuss how the pharmaceutical industry has changed – and stayed the same – in the last 2 decades. Sarah talks about the global value of the pharmaceutical industry in 2002 versus today and which companies made the top 3 based on revenue.

Sarah also shared the top-selling drugs in 2002, 2012 and 2022, and how much the industry as a whole has invested in R&D in those years. The team discusses the number of new drugs and biologics approved by the FDA each year, and debates whether the regulator will be able to keep up with growing submission numbers and the expectation of speedy approval decisions. 

The team also talked about the role of Xtalks in knowledge dissemination and facilitating meaningful conversations in the pharma industry through webinars, written content, videos and, of course, this podcast!

To read more, visit Pharma By The Numbers: A Retrospective Look at the Industry and 20 Years of Xtalks History. For a closer look at the stats discussed in this episode, check out this infographic.

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This episode features an interview with Manu Garg, VP, Head of Healthcare Consulting at Definitive Healthcare. Sarah and Manu discussed the transformative role of healthcare commercial intelligence in the industry today, and how machine learning (ML) and artificial intelligence (AI) are changing care delivery for patients. 

As new drug development is increasingly focused on targeted therapies for rare diseases and other indications with limited patient pools, healthcare commercial intelligence can help companies find their target market and help direct resources. Manu explained how both large and small pharmas, biotechs and medtechs can benefit from Definitive Healthcare’s SaaS-based tools.

Manu explained how AI is helping to predict tumor mutations so that cell and gene therapies can be targeted to individual patient’s needs, realizing the true promise of “personalized medicine.” He also discussed why the healthcare sector needs to adopt new ways of using patient-generated device-based health data to bring care to patients when and where they need it.

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This episode features an interview with Howard Look, CEO and co-founder of Tidepool, a non-profit organization that has a range of software tools for people with diabetes and the clinics that serve them. 

Tidepool recently received US Food and Drug Administration (FDA) clearance of Tidepool Loop, an automated insulin dosing app meant for the management of type 1 diabetes in patients who are six years of age and older. Howard spoke about the FDA clearance and discussed how Tidepool Loop addresses an unmet need in the type 1 diabetes space.

Howard shared his story about his personal connection to diabetes and what prompted him to start Tidepool. He discussed his strategy for engaging stakeholders — the patients, health care providers, caregivers and payers — to pave the way for individuals with type 1 diabetes to access Tidepool Loop.

Hear more about Tidepool Loop and Tidepool’s continuing work in the diabetes management space.

Read more here:

Tidepool Loop Is FDA Cleared as an Automated Insulin Dosing App for Type 1 Diabetes

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This episode features an interview with Diarmuid Flavin, Chief Operating Officer (COO) of Neuromod, a Dublin-based medical device company specializing in the treatment of tinnitus, a condition known as “ringing in the ears.” Tinnitus is believed to impact between 10 to 15 percent of adults worldwide.

The company recently received De Novo approval from the FDA for its tinnitus treatment Lenire. Lenire is the first of its kind, non-invasive, bimodal neuromodulation device that stimulates nerves to treat tinnitus. Diarmuid spoke about the approval and how Lenire helps address a significant unmet need in the tinnitus space.

Diarmuid brings more than 25 years of global leadership experience in a range of medical device, technology, and pharmaceutical companies to Neuromod, where he assumes responsibility for the company’s strategic operational execution, Regulatory Affairs, Engineering & Technology, Manufacturing Operations and Supply Chain teams.

Hear more about Lenire and Neuromod’s continuing work in biomodal neuromodulation technologies.

Read more here:

Lenire Bimodal Neuromodulation Device by Neuromod Improves Tinnitus Symptoms in Clinical Trial

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In this episode, Ayesha talked about the FDA approval of Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) for the treatment of geographic atrophy, a leading cause of blindness. The condition is an advanced form of dry age-related macular degeneration (AMD) for which there have been no treatment options up until this recent approval. Hear more about the drug, including some questions about its clinical benefit.

Ayesha also talked about the FDA’s emergency use authorization (EUA) of Lucira Health’s over-the-counter (OTC) combination COVID-19 and flu diagnostic that can be administered at-home. The molecular PCR test is the first at-home combination test that can differentiate and detect the Influenza A, B and SARS-CoV-2 viruses in 30 minutes or less. The editorial team discussed the utility of the test, including settings in which they may be useful in and whether they may even be needed at all.

Read the full articles here:

Apellis’ Syfovre Approved as First Treatment for Geographic Atrophy Despite Uncertain Clinical Benefit

FDA Authorizes First At-Home Combination COVID and Flu Test

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In this week’s Xtalks Life Science podcast episode, Sarah spoke with Doug Biehn, Chief Commercial Officer at Cala Health, a bioelectronic medicine company that develops wearable neuromodulation therapies.

The company’s lead product, Cala Trio, was approved by the US Food and Drug Administration (FDA) in 2018 for transient relief of hand tremors in adults with essential tremor (ET).

Tune into the episode to learn more about Cala Health’s individualized prescription neuromodulation therapy. Doug discussed the day-to-day struggles of patients with ET and the challenges they face when seeking medication for their condition. Doug also shared the benefits of Cala Trio for the relief of hand tremors and how company is committed to ensuring all patients have access to this life-changing neuromodulation therapy.

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In this episode, Ayesha talked about the FDA clearance of a new at-home sleep apnea test developed by Belgium-based scale-up Sunrise. The wireless, AI-powered device is placed on a user’s chin, making it non-invasive and easy to use. The test has been clinically validated against traditional polysomnography testing and can help provide an accurate sleep apnea diagnosis. Hear more about the device in this episode.

Ayesha also talked about the teaming up of basketball legend Kareem Abdul-Jabbar and the Bristol Myers Squibb/Pfizer Alliance for a new ad campaign to help raise awareness about atrial fibrillation (AFib). The basketball Hall of Famer was diagnosed with the condition and in a video for the campaign, he describes how he initially dismissed his symptoms. He encourages others to learn from his experience and seek medical attention as soon as any symptoms appear. February is also American Heart Month, which is marked every year to help promote awareness about cardiovascular health. 

Read the full articles here:

Sunrise’s At-Home Sleep Apnea Test Gets FDA Clearance 

‘No Time to Wait’ Ad Campaign from BMS-Pfizer Features Basketball Legend Kareem Abdul-Jabbar for AFib Awareness 

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In this week’s Xtalks Life Science podcast episode, Ayesha and the editorial team spoke with Dr. Bastiaan Driehuys, Founder and Chief Technology Officer at Polarean Imaging. 

Polarean is a medical imaging company focused on improving the state of lung imaging. The company recently received FDA approval for its drug device combination product, Xenoview. Xenoview is a hyperpolarized contrast agent, prepared from the Xenon 129 Gas Blend, that is indicated for use with MRI to evaluate lung ventilation in adults and pediatric patients 12 years of age and older. 

Tune into the episode to learn more about the FDA approval of Xenoview, including the journey to its approval. Hear about Dr. Driehuys’ extensive research career developing hyperpolarized Xenon 129 as an MRI contrast agent and how that led him to co-found Polarean with the goal of improving the state of lung imaging.

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In this episode, Ayesha talked about the launch of Amgen’s Amjevita, the first Humira biosimilar to hit the market. Amjevita received FDA approval in 2016 and after a legal settlement with Humira maker AbbVie, has finally reached market launch. AbbVie has been embroiled in legal battles over accusations of overpatenting and price hiking to block Humira biosimilar competition. Hear more about Amjevita and how 2023 is a big year for Humira biosimilars with over half a dozen more launching this year.

Ayesha also discussed new Alzheimer’s research from Kings College London that could lead to the development of a blood test for the early detection of the disease. The research found that certain biomarkers in the blood of patients with mild cognitive impairment (MCI), which some Alzheimer’s patients develop before being diagnosed with the disease, could predict the onset of Alzheimer’s up to 3.5 years before a clinical diagnosis is made. Learn more about the new research in this episode.

Read the full articles here:

Amgen’s Amjevita Enters Market as First Humira Biosimilar, But at Two Different Price Points

Early Detection of Alzheimer’s Disease: New Research Shows How a Blood Test Could Lead to Earlier Diagnosis

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In this week’s Xtalks Life Science podcast episode, Ayesha and the editorial team spoke with Susan Benton, Country Manager at Thea Pharma, an eye care company that focuses on developing innovative eye care treatments to help further the future of ophthalmic treatment.

Thea Pharma recently won FDA approval for its latest eye care product Iyuzeh for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Iyuzeh is the first and only preservative-free formulation of the medication latanoprost in the US. 

To talk more about the new FDA approval for Iyuzeh and about the great work being done at Thea Pharma, tune in to hear this informative and insightful interview with Susan Benton, who has more than 25 years of global commercial and business development experience in ophthalmic pharmaceuticals, and has been responsible for the launch and commercialization of more than 15 products over the course of her career.

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In this week’s episode, Ayesha discussed the new Omicron subvariant XBB.1.5, also known as Kraken, which is rapidly circulating in parts of the US. It is the most transmissible variant yet and is highly immune evasive. COVID-19 cases have been on the rise in the country, including significant increases in hospitalizations and deaths. While XBB.1.5 has been found in dozens of other countries now, cases remain low around the world. Hear more about the new subvariant and why scientists are keeping a close eye on it.

Ayesha also talked about the FDA approval of AstraZeneca’s asthma inhaler Airsupra, the first-in-class drug that contains both a beta agonist and corticosteroid. The inhaler is approved as a rescue medication for adults with asthma to help treat bronchoconstriction and asthma attacks. It’s the first inhaler that both treats symptoms and the underlying causes of an attack by targeting inflammation of the airways.

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XBB.1.5 Omicron Subvariant Being Closely Watched as Most Transmissible Variant Yet

AstraZeneca’s Airsupra Approved as First-In-Class Combo Asthma Treatment

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In this week’s Xtalks Life Science podcast episode, Ayesha and the editorial team spoke with Dr. Monique Gary, or Dr. Mo, a breast surgical oncologist, researcher, advocate and expert on cancer and healthcare disparities.

Dr. Mo is passionate about developing integrative, holistic and innovative approaches to cancer treatment, prevention and survivorship both locally and throughout the world. She serves on the board of several community organizations and was recognized as a Leading Physicians of the World and Top Breast Surgeon in Pennsylvania for 2017, 2018 and 2019. 

On the show, Dr. Mo spoke about disparities in breast cancer treatment and care. particularly among minorities, including Black women. She shared ways in which patients can advocate for themselves; discussed some of the advancements in breast cancer screening and prevention; improving clinical trial participation; and the importance of strengthening relationships and communication between patient and physician communities. Hear the informative and insightful conversation in this episode.

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In this episode, Ayesha talked about some of the trends to look out for in the life sciences in 2023. With a handful of significant gene therapy approvals in 2022, the cell and gene therapy space continues to rapidly expand, and hence we can expect more ground-breaking gene therapy approvals in the coming year, particularly for rare diseases. As our world becomes increasingly digitized, this includes greater implementation of digital health in healthcare. What are the roadblocks and potential burdens of digital health, and can healthcare go completely digital? Also hear about the issue of drug shortages and how pharma companies hope to tackle it in 2023. 

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4 Life Sciences Trends for 2023

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In this week’s Xtalks Life Science podcast episode, Ayesha and the team spoke with the co-founders and co-CEOs of Amylyx, Joshua Cohen and Justin Klee, and Amylyx’s General Manager of Canada Chris Aiello.

Amylyx is a pharmaceutical company focused on the development of therapies for neurodegenerative diseases. On September 29th this year, Amylyx received FDA approval for its oral, fixed dose medication Relyvrio for the treatment of adults with amyotrophic lateral sclerosis (ALS). A few months earlier, the medication had received conditional approval in Canada, where it is marketed under the brand name Albrioza. To hear more about Relyvrio’s approval, including how the Ice Bucket Challenge for ALS helped in the drug’s development, and Amylyx’s continuing work in neurodegenerative diseases, tune into the episode.

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Relyvrio Approved as ALS Treatment by the FDA

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In this episode, Ayesha talked about the FDA approval of Ferring Pharmaceuticals’ fecal matter-based therapy Rebyota for the treatment of recurrent C. difficile infections. While fecal matter transplants (FMT) have been a standard of care for recurrent CDIs, despite not having formal approval, Rebyota has become the first FDA approved FMT-based treatment for CDIs. Hear more about the drug and its approval in this episode. 

Ayesha also discussed a new CBD oral capsule being developed by PureTech Health for the treatment of epilepsy and potentially other indications as well. The drug will be going up against Jazz Pharma’s Epidiolex, which was first approved in 2018 for the treatment of seizures associated with rare types of epilepsy. Hear about the advantages of an oral capsule formulation of CBD, including lower costs and not requiring the use of sesame oil.

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FDA Approves Rebyota as First Fecal Microbiome Therapy for Recurrent C. Difficile Infection

PureTech Reveals New CBD Pill to Rival Jazz’s Epidiolex

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In this episode, Ayesha shared news about the FDA approval of the first gene therapy for the rare blood disorder Hemophilia B. The approval was awarded to CSL Behring’s Hemgenix, a single-dose gene therapy that delivers a working copy of the gene that codes for the Factor IX protein that is deficient, or made in insufficient amounts, in patients with Hemophilia B. The therapy is now officially the world’s most expensive drug at $3.5 million per dose. Hear more about the therapy and how the high price tag of the new drug is actually lower than the cost of treating Hemophilia B patients over their lifetimes with current conventional treatment.

Ayesha also talked about World Antimicrobial Resistance (AMR) Awareness Week, which is led by the World Health Organization (WHO) to improve awareness and take measures to combat the global health threat of AMR. The theme of this year’s awareness week was “Preventing AMR Together,” highlighting the need for multi-disciplinary and collective action against AMR. Ayesha spoke to experts from bioMérieux Canada and One Health to learn more about the global efforts against AMR and shared their insights in this episode.

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Hemgenix Approved as First Gene Therapy for Hemophilia B

World Antimicrobial Resistance (AMR) Awareness Week: Preventing AMR Together

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In this episode, Ayesha talked about the breakthrough FDA approval of Provention Bio’s Tzield for delaying the onset of type 1 diabetes in adult and pediatric patients. It’s the first approved treatment for slowing the progression of stage 2 type 1 diabetes to stage 3, the stage at which a clinical diagnosis is made. Tzield is an immunotherapy that was in development for over three decades. Find out more about the drug and how it may be a gamechanger for type 1 diabetes.

Ayesha also talked about the latest positive Phase III trial data that Pfizer recently shared for its maternal RSV vaccine candidate. The data showed that the vaccine led to a significant reduction in the rate of severe medically attended lower respiratory tract illness (MA-LRTI) in newborns, a complication that can result from respiratory syncytial virus (RSV) infection. Hear more about the vaccine trial data, based on which an independent data monitoring committee has recommended that Pfizer file with the FDA for approval.

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Tzield Gets FDA Nod to Become First Approved Drug to Delay Onset of Type 1 Diabetes

Pfizer Shares Positive Phase III Data for Maternal RSV Vaccine Candidate

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In this episode, Ayesha discussed Novo Nordisk’s Ozempic (semaglutide) shortage, largely attributed to off-label prescribing for weight loss and viral TikTok videos. The GLP-1 agonist is indicated as a type 2 diabetes treatment but has weight loss as a side effect. The shortage could give competitor Eli Lilly’s new dual GIP/GLP-1 agonist Mounjaro added market advantage, but can the company meet the unprecedented demand?

Ayesha also talked about Eli Lilly falling victim to a fake Twitter account that tweeted the company was offering free insulin. The fraudulent account has a blue check, which users can purchase through a $8 per month subscription for the revamped Twitter Blue program introduced by Elon Musk. Lilly clarified the fake message, but the tweet has re-ignited debate about the cost of insulin in the US.

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Novo Nordisk’s Ozempic Shortage Spurs Demand for Eli Lilly’s Diabetes Injection Mounjaro

Fraudulent Eli Lilly Twitter Account Announces Free Insulin

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In this episode, Ayesha and the editorial team spoke with Peter Sallstig, MD, MBA, Global Head of Product Development Division and Chief Medical Officer (CMO) at Santen Pharmaceuticals, a biotech company focused on leveraging key, innovative technologies to develop solutions for eye-related problems worldwide. Recently, Santen received FDA approval for the company’s OMLONTI eye drops for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. In this interview, Dr. Sallstig spoke about OMLONTI, what makes his work and team at Santen so special and the company’s commitment to innovations in eye health. 

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In this episode, Ayesha discussed the FDA approval of two new immunotherapies, including Janssen/Johnson & Johnson’s bispecific antibody Tecvayli for the treatment of relapsed or refractory multiple myeloma. The drug is the first bispecific T cell antibody to be approved in the US. It is indicated as a fifth line treatment for multiple myeloma patients who have received four or more prior treatments. Find out more about the bispecific antibody and about trials evaluating it in combination with other drugs to potentially move up its treatment line.

Ayesha also talked about the FDA approval of AstraZeneca’s immunotherapy Imjudo for hepatocellular carcinoma (HCC), which is the most common type of liver cancer. The drug is indicated for use in combination with AstraZeneca’s PD-L1 inhibitor Imfinzi in adult patients with unresectable HCC. The new drug combination will be going up against Roche’s combo of Tecentriq and Avastin, which recently became the standard of care for HCC. Despite this, the Imjudo and Imfinzi approval offers another promising treatment option for HCC patients and is the first dual immunotherapy treatment regimen for this indication.

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Multiple Myeloma Drug Tecvayli Becomes First FDA-Approved Bispecific T Cell Antibody

AstraZeneca’s Immunotherapy Imjudo (tremelimumab) Wins FDA Approval for Liver Cancer

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In this episode, Ayesha and the editorial team spoke with prominent cystic fibrosis and rare disease patient leader Gunnar Esiason to learn more about his advocacy work, including his work in clinical trials and developing patient-facing technologies. Gunnar has consulted on clinical trial development, a real-world evidence population health study and a cystic fibrosis-specific mental health and wellness screening tool. He has been the face of fundraising efforts for the Boomer Esiason Foundation, which has raised more than $160 million for the fight against cystic fibrosis since he was diagnosed with the condition in 1993. He also has a successful blog and has co-hosted and hosted podcasts, with his most recent one called The State of Health with Gunnar Esiason, which has featured sitting US senators, governors and health industry leaders. Hear more about Gunnar’s work and his passion for patient advocacy and improving rare disease clinical research in this episode of the Xtalks Life Science podcast.

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In this episode, Ayesha discussed Elon Musk’s recent revelation that in addition to fasting, he also used Novo Nordisk’s weight loss drug Wegovy to help him get “lean and fit.” In response to a question on Twitter, Musk disclosed that both fasting and Wegovy were his secrets to his recent weight loss. Musk is not affiliated with Novo so his endorsement of the drug came as a surprise, and is also problematic according to some. Hear more about the story in this episode.

The editorial team also learned about the FDA approval of Nevro Corp’s AI-based spinal cord stimulation (SCS) system for the treatment of chronic pain. Nevro says its Senza HFX iQ system is the first and only AI-based SCS system that personalizes care by “learning from patients.” The implantable device delivers neurostimulation via the company’s proprietary high frequency pulse technology that has been evaluated in more than 90,000 patients. 

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Elon Musk Reveals Weight Loss Injection Wegovy Helped Him Get Lean and Fit

Nevro’s AI-Based Spinal Cord Stimulation Device for Chronic Pain Receives FDA Approval

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In this episode, Ayesha and the editorial team spoke with Caroline Hamilton, Clinical Director of Neuromod Devices, a medical technology company that specializes in the design and development of neuromodulation technologies. The company is committed to addressing the clinical needs of underserved patient populations who live with chronic and debilitating conditions globally. Caroline spoke to Xtalks about Neuromod’s proprietary, patented bimodal neuromodulation technology that it is evaluating for neurological disorders. The lead application of Neuromod's technology is the Lenire device for the treatment of tinnitus, frequently referred to as “ringing in the ears.” Tinnitus is believed to impact between 10 to 15 percent of adults worldwide. Hear more about Neuromod’s Lenire device, including clinical and real-world data showing its effectiveness in improving symptoms of tinnitus.

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In this episode, Ayesha and the editorial team spoke with Pierre Bertrand, CEO of vision care biotech Neurolens, developer of innovative new technology to address digital vision syndrome. The syndrome is caused by extended computer or digital device use that can result in eyestrain as well as neck and shoulder pain. Hear more about the company’s Neurolenses, which are designed to alleviate and even prevent symptoms of digital vision syndrome. Learn about the proprietary technology behind Neurolenses and recent results from clinical studies that show its effectiveness in improving eye function and comfort.

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In this episode, Ayesha discussed the FDA approval of bluebird bio’s Skysona for slowing the progression of neurologic dysfunction associated with the rare neurological disorder cerebral adrenoleukodystrophy (CALD) in boys four to 17 years of age with early, active CALD. The one-time administered gene therapy has also taken the title of being the world’s most expensive drug at $3 million. Hear more about the treatment and how the high prices of gene therapies can be alarming, but reimbursement programs are designed to pick up the costs.

Ayesha also talked about the emergence of a new COVID-19 variant called BF.7 that the CDC is closely watching. The new strain of the coronavirus is a subvariant of the BA.5 Omicron variant. It appears to be more transmissible than other variants and subvariants and its incidence has doubled in just two weeks according to the latest CDC data. Find out more about BF.7 including how it could drive the new anticipated wave of COVID infections this fall.

Read the full articles here:

Bluebird Bio’s Skysona Receives FDA Approval and Becomes World’s Most Expensive Drug

CDC Expresses Concern Over New COVID-19 Variant BF.7

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In this episode, Ayesha shared new research about how scientists at the Francis Crick Institute and University College London have found a mechanism of action to explain how air pollution may cause lung cancer in non-smokers. The research findings revealed that people who live in polluted areas have a higher risk of lung cancer, and that particulate matter smaller than 2.5 micrometers (PM2.5) can act on existing genetic mutations to trigger inflammation and the development of cancer. Hear more about the research findings in this episode.

Ayesha also talked about how a woman with a unique ability to smell Parkinson’s disease has helped scientists develop a new test that may aid in the early diagnosis of the condition. The Scottish woman was able to detect something was off with her husband’s body odor more than a decade before he was diagnosed with Parkinson’s disease. Find out more about how researchers leveraged her powerful sense of smell to develop the new test.

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New Research Reveals How Air Pollution May Trigger Lung Cancer

Scientists Develop Test for Parkinson’s Based on Woman’s Ability to Smell the Disease

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In this episode, Ayesha discussed the FDA approval of Sanofi’s enzyme replacement therapy Xenpozyme for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare genetic lysosomal storage disease, in adults and pediatric patients. The drug is administered intravenously every two weeks and in clinical trials, demonstrated significant improvements in lung function as well as reductions in spleen and liver sizes. Hear more about the rare, fatal disease and the new drug approval for it.

Ayesha also talked about Medtronic’s new partnership with former Disney star Jennifer Stone on a new ad campaign for its diabetes tech, including the smart insulin injector InPen. Hear about Jennifer’s story as a type 1 diabetes patient and how the InPen helps patients like her simplify their diabetes management. Through the ad campaign, Medtronic is hoping to increase awareness about advanced diabetes tech like the InPen. The company is also working on new connected tech to integrate its different diabetes device offerings.

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Sanofi’s Enzyme Replacement Therapy Xenpozyme Wins FDA Approval for Rare Disease ASMD

Medtronic’s InPen Gets Backing from Disney Star Jennifer Stone in Diabetes Tech Campaign

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In this episode, Ayesha discussed Fitbit’s new lineup of smartwatches that is set to release this fall, including the Sense 2 which has a sensor for the detection of atrial fibrillation (AFib). Fitbit said the Sense 2 is its most advanced health-focused smartwatch to date. The device has a sensor that can identify signs of AFib through the company’s electrocardiogram (ECG) app and photoplethysmography (PPG) algorithm. Hear more about the AFib detection feature as well as the smartwatch’s new Body Response sensor for stress management. 

Ayesha also discussed the FDA approval of Imbruvica (ibrutinib) for pediatric patients one year of age and older with chronic graft-versus-host disease (cGVHD). This is the BTK inhibitor’s first approval for a pediatric indication, and the first approved liquid form of the drug. The approval addresses an unmeet need in this indication, as treatment options for cGVHD in younger children are limited. Learn more about the approval in this episode of the Xtalks Life Science Podcast.

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Fitbit Sense 2 Smartwatch with AFib Detection to Launch This Fall

Imbruvica Wins Milestone Approval for Children as Young as 1 With Chronic GVHD

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In this episode, Ayesha discussed the FDA approval of Axsome Therapeutics’ rapid-acting oral treatment Auvelity for the treatment of major depressive disorder (MDD). The approval makes Auvelity the first and only rapid-acting oral medication for depression, and the first and only oral NMDA receptor antagonist approved for MDD. Hear more about the approval, including clinical trial data showing the treatment can take effect in as little as one week, and how it is the first antidepressant approved in over 60 years that has a new mechanism of action.

Ayesha shared news about another significant FDA approval for a gene therapy to treat transfusion-dependent beta thalassemia. Bluebird bio was awarded the approval for its gene therapy Zynteglo (beti-cel), which is a one-time treatment for the rare blood disorder. Hear more about the therapy, some of the setbacks bluebird has had to face on the road to its approval and why the treatment has a steep price tag.

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Axsome’s Auvelity Wins FDA Approval as First Rapid-Acting Oral Treatment for Depression

Bluebird’s $2.8M Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia

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This episode features an interview with Dr. Asaf Zviran, CEO and co-founder of C2i Genomics, a biotech company focused on improving cancer detection and monitoring using genomics- and AI-based approaches. Hear about the company’s proprietary cancer surveillance technology, how Dr. Zviran’s founded C2i Genomics, including a personal story, and how the company is focused on truly personalizing cancer treatments.

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In this episode, Ayesha discussed the UK’s approval of Moderna’s next generation COVID-19 vaccine that targets both the original strain of SARS-CoV-2 and the Omicron variant of concern. Hear more about the bivalent booster shot, including clinical trial data that led to its approval. Also, hear what Moderna officials have to say about the administration schedule of the new shot.

Ayesha also talked about National Immunization Awareness Month, which is marked every August in the US. Health agencies like the FDA and CDC are not only on the regulatory side of vaccines, but are also committed to helping raise awareness about the importance of vaccines among the public. As part of this, the health agencies suggest healthcare providers should 'strongly recommend' vaccines. Vaccine 'catch up' campaigns are also important now since other non-COVID vaccinations, including routine childhood vaccinations, have lagged during the pandemic. 

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 UK Approves First Omicron-Targeting COVID-19 Booster

National Immunization Awareness Month: Vaccines Work and Catching Up

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In this episode, Ayesha discussed a new COVID-19 test technology that Innova Medical Group, world leader in at-home COVID-19 tests, has reached a licensing deal for with the University of Birmingham where the technology was developed. The new test is as sensitive and accurate as PCR tests and faster than lateral flow (rapid antigen) tests. Hear about the innovative new technology underlying the molecular test, and how the test is also being developed for the detection of other viruses. 

Ayesha also talked about the FDA approval of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. The approval makes Enhertu the first approved drug for this indication. Find out about the trial data that led to the approval and its effectiveness in HER2-low breast cancer, which is a newer subtype of the cancer.

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Innova Secures Licensing Rights for U of Birmingham’s New COVID-19 Test Technology RTF-EXPAR

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In this episode, Ayesha discussed the FDA approval of Azurity Pharmaceutical’s Zonisade (zonisamide oral suspension) as an adjunct therapy for the treatment of seizures in adults and pediatric patients 16 years of age and older with epilepsy. The drug is the first FDA approved oral suspension form of zonisamide. Hear about how the drug could help increase accessibility and flexibility for epilepsy patients and improve treatment adherence.

Ayesha also talked about biopharmaceutical company Incyte’s new vitiligo drug Opzelura that recently received FDA approval for the treatment of nonsegmental vitiligo. The topical medication is the first approved treatment for repigmentation in vitiligo and also the first approved topical JAK inhibitor in the US. Hear more about raising awareness about rare diseases like vitiligo and how it can help foster the development of new treatments. 

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Zonisamide Liquid Form Gets FDA Approved for Epilepsy Treatment

Opzelura Vitiligo Med Wins FDA Approval as First Treatment for Repigmentation

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In this episode, the editorial team spoke with the President and CEO of regenerative medicine biotech Sernova Corp Dr. Philip Toleikis to learn more about how the company is developing a ‘functional cure’ for diabetes. The team heard from Dr. Toleikis about Sernova’s proprietary Cell Pouch System that is designed to house therapeutic cells. Dr. Toleikis spoke about the latest clinical trial data for the medical device, and also about the company’s new partnership with Evotec to integrate its insulin-producing cells in the Cell Pouch System.

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In this episode, Ayesha discussed the FDA authorization of Novavax’s COVID-19 vaccine, making it the fourth authorized/approved COVID vaccine in the US. It is also the first protein-based COVID-19 vaccine to be authorized in the country. While the vaccine offers an alternate option to people who may still be hesitant about mRNA vaccines, hear why some experts think it won’t have much of an impact on those who are choosing to remain unvaccinated. 

Ayesha also talked about the expanded label approval of Horizon Therapeutics’ gout medication Krystexxa to include its co-administration with arthritis and chemotherapy drug methotrexate. The new approved combination is indicated for the treatment of uncontrolled gout, a rare condition in which patients fail to respond to conventional treatments due to problems including drug resistance. Hear more about gout and the rare condition of uncontrolled gout in this episode.

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Novavax Vaccine Becomes First FDA-Authorized Protein Vaccine for COVID-19

Krystexxa Chronic Gout Medication Gets Expanded FDA Approval

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In this episode, Ayesha talked about a safety warning issued by the US Food and Drug Administration (FDA) for Secura Bio’s Copiktra (duvelisib), which is a drug used to treat adults with relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL). The FDA flagged the drug after evaluating long-term survival data, which showed that the drug was associated with a higher risk of serious side effects and a possibly increased risk of death. 

Ayesha also talked about a new nuclear magnetic resonance (NMR)-based molecular research tool for the assessment of the risk of Long COVID, including multi-organ damage and cardiovascular disease risk. The phenomics tool is being developed by Bruker for research purposes and is based on well-characterized metabolic and proteomic biomarkers associated with Long COVID. Hear more about the tool and how it can help patients receive appropriate treatment interventions early for Long COVID.

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Copiktra Blood Cancer Drug Gets FDA Warning Due to Increased Risk of Serious Side Effects and Death

Bruker Develops New Tool for Assessing Long COVID Risk

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In this episode, Ayesha discussed a new collaboration between leading medical technology company Becton Dickinson (BD) and CerTest Biotec who will work together to develop a molecular diagnostic test for the detection of the monkeypox virus. Learn about how BD will leverage its BD MAX platform to develop and validate CerTest’s under development monkeypox test amid an anticipated growing demand for testing given increasing cases of monkeypox infection around the world.

Ayesha also talked about the US Food and Drug Administration (FDA)’s amended authorizations for Pfizer-BioNTech’s and Moderna’s COVID-19 vaccines to include children as young as six months old. The authorizations were based on the FDA’s analysis of efficacy and safety data in pediatric populations. Hear about the vaccine trials and parents’ attitudes towards vaccinating younger children.

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Monkeypox Test Kit in Development by Becton Dickinson in Partnership with CerTest Biotec

FDA Authorizes Pfizer and Moderna COVID-19 Vaccines for Children Under Five After Unanimous Advisory Panel Support

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In this episode, Ayesha and the team talked about the FDA approval of Eli Lilly’s JAK inhibitor Olumiant for the treatment of alopecia areata, also commonly just known as alopecia. The drug has become the first approved systemic treatment for the autoimmune disorder that causes patchy hair loss. Hear about how alopecia has received mainstream recognition because of a recent infamous Hollywood incident and the importance of raising awareness about rare diseases like alopecia.

Ayesha also discussed the FDA approval of Alnylam’s RNAi therapeutic Amvuttra for the treatment of polyneuropathy associated with a rare protein disorder called hereditary transthyretin-mediated (ATTR) amyloidosis. Hear about how the drug is also being evaluated for another type of (ATTR cardiomyopathy) and the other big players in the ATTR space including Pfizer and AstraZeneca.

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Eli Lilly’s Olumiant Wins FDA Approval as First Systemic Treatment for Alopecia Areata

Amvuttra RNAi Therapeutic Wins FDA Approval for Rare Genetic Protein Disorder

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In this episode, Ayesha discussed new data shared by Eli Lilly for its weight loss injection tirzepatide. The drug was recently approved (under the brand name Mounjaro) by the US Food and Drug Administration (FDA) for the treatment of type 2 diabetes. The dual GIP/GLP-1 receptor agonist also has weight loss effects and recent analyses presented at the American Diabetes Association’s 82nd Scientific Sessions showed that almost 40 percent of participants lost a quarter of their body weight. Hear more about the newest data and industry predictions for tirzepatide as a rival to Novo Nordisk’s GLP-1 receptor agonist weight loss injection Wegovy.

The editorial team also discussed a new global biosimilars awareness campaign launched by Sandoz, Novartis’ biosimilars and generics drug division. The campaign is called Act4Biosimilars and will focus on improving the acceptability and accessibility to biosimilars, among factors, by 30 percent in over 30 countries by the year 2030. The campaign is aimed at addressing global health inequity and inequality by increasing access to advanced medicines like biosimilars. The team discussed the importance of education around biosimilars to help increase their acceptability and uptake.

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More Positive Data for Eli Lilly’s Diabetes and Weight Loss Injection Tirzepatide

Novartis’ Sandoz Launches Biosimilars Awareness Campaign to Improve Biosimilars Adoption Worldwide

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This episode features an interview with Georgia Institute of Technology researcher Dr. Woon-Hong Yeo who has helped lead a team of researchers to develop a novel vascular monitoring system based on a specially designed smart stent. Hear about how the implantable smart stent system offers real-time and continuous monitoring of metrics like blood pressure and blood flow, as well as Dr. Yeo’s personal motivation for creating the vascular monitoring system to help people monitor their cardiac health. Dr. Yeo is a Woodruff Faculty Fellow; Associate Professor in Mechanical Engineering and Biomedical Engineering; and the Director of the Center for Human-Centric Interfaces and Engineering at Georgia Tech.

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In this episode, Ayesha and the editorial team spoke with Dr. Samantha Dale Strasser, chief scientific officer and co-founder of biotech start-up Pepper Bio. The company is working to develop therapeutics in the areas of oncology, neurodegenerative disease and inflammatory conditions using a ‘transomics’ drug discovery approach. This involves the integrated analysis of several layers of biological data, including genomic, proteomic, transcriptomic and phosphoproteomic data using novel transomics technologies involving lab methods and AI approaches. Hear more about Pepper Bio as well as Dr. Strasser’s journey from academia to the biotech industry.

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In this episode, Ayesha discussed the FDA approval of Eli Lilly’s diabetes injection Mounjaro (tirzepatide) for the treatment of adults with type 2 diabetes This is a great advancement in the diabetes space as Mounjaro is a first-in-class medicine that targets the activity of two hormones involved in hunger and blood sugar control (GLP-1 and GIP). With the approval, Eli Lilly will be giving Novo Nordisk’s blockbuster diabetes injection Ozempic some tough competition. Hear about the projected sales of Mounjaro, data from studies that led to its approval and its impact from a patient perspective.

Ayesha also talked about the current monkeypox outbreak as clusters of cases continue to be reported in countries in Europe and North America. The US recently reported its first case of monkeypox, and all cases so far are linked to international travel. Learn more about monkeypox and how health authorities are asking people not to panic as most cases are mild and treatable. Also hear about how Britain is offering the smallpox vaccine to healthcare workers to help prevent infection from the monkeypox virus.

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Mounjaro (tirzepatide), Eli Lilly’s Highly Awaited Type 2 Diabetes Injection Gets FDA Nod

Monkeypox Case Reported in the US as Virus Spreads Across Europe and North America

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In this episode, Ayesha discussed a new study that evaluated a text messaging program designed to improve medication adherence and lifestyle factors among heart attack survivors. While the program did not lead to improvements in medication adherence, it did have a positive impact on lifestyle factors like diet. Hear more about the study and the importance of managing heart attack risk factors like hypertension and diabetes. This is especially relevant on World Hypertension Day (May 17) and May Measurement Month, which bring awareness to the importance of accurately measuring blood pressure.

Ayesha also talked about the FDA’s decision to place stricter restrictions on the use of Janssen/Johnson & Johnson’s COVID-19 vaccine given continuing concerns of the rare but serious side effect of blood clots. Hear about why the FDA revised the vaccine’s authorization, and why the FDA maintains that the vaccine’s benefits outweigh any known or potential risks.

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How Heart Attack Survivors Can Improve Lifestyle Factors with a Text Messaging Program

FDA Puts Further Restrictions on Use of Janssen/Johnson & Johnson COVID-19 Vaccine

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In this episode, Ayesha discussed Bristol Myers Squibb’s new heart drug Camzyos (mavacamten), which has received approval from the US Food and Drug Administration (FDA) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The drug is the first to target the pathophysiology of obstructive HCM and may be Bristol Myers’ next blockbuster cardiac drug. Hear more about the company’s looming patent cliff for some of its drugs as well as the company’s risk evaluation program for Camzyos given some of its safety concerns.

Ayesha also talked about a new ovarian cancer blood test developed by researchers at the University of Manchester that may help diagnose the disease quicker and more accurately, especially in younger women. The test includes a newer ovarian cancer biomarker that when used in combination with CA-125, the biomarker currently used to monitor and screen for ovarian cancer in some cases, could improve its diagnostic value. Learn more about the test and about the importance of women’s health advocacy in the early detection of diseases like ovarian cancer.

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Researchers Use Emerging Ovarian Cancer Biomarker to Develop New Blood Test for Ovarian Cancer

Camzyos Secures FDA Approval for Obstructive HCM, Bristol Myers Eyes it as its Next Big Cardiac Drug

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In this episode, Ayesha discussed the FDA approval of Mycovia Pharmaceuticals’ Vivjoa (oteseconazole) as the first approved treatment for recurrent vulvovaginal candidiasis (RVVC) or chronic yeast infection. The drug is indicated for women who permanently lack reproductive potential or are postmenopausal. The editorial team discussed the significant unmet need for this condition and how although many women’s health issues are now given greater spotlight, there still need to be more conversations around them. The episode marked World Maternal Mental Health Day and was sponsored by Elligo Health Research.

The editorial team also talked about the latest results of Eli Lilly’s investigational obesity drug tirzepatide, which demonstrated it could reduce body weight by an average of 20 percent in individuals without diabetes. Tirzepatide is a GLP-1 receptor agonist, a class of drugs designed to treat diabetes but at higher doses, can help with weight loss. Hear more about the drug and the obesity drug market, which is projected to grow to $5.42 billion in 2025.

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Oteseconazole (Vivjoa) Becomes First FDA-Approved Drug for Recurrent Yeast Infection

Tirzepatide Obesity Drug Shown to Reduce Body Weight by 20 Percent in Eli Lilly Trial

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In this episode, Ayesha talked about World Immunization Week, which is celebrated during the last week of April every year. The theme of this year’s World Immunization Week is “Long Life For All,” which aims to communicate the importance of vaccines for a healthy and fulfilling life by protecting yourself and your loved ones against deadly diseases. Immunization programs were impacted by the COVID-19 pandemic but find out how immunization rates have been on the decline, particularly in developing countries, which have led to the resurgence of diseases like polio and measles.

The editorial team also discussed a new COVID-19 breathalyzer test that recently received emergency use authorization (EUA) from the US Food and Drug Administration (FDA). The mobile rapid test generates results in just three minutes from a sample of exhaled air. Hear more about how the test in the podcast, including how it works and about its high degree of sensitivity and specificity that edges out rapid antigen tests.

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World Immunization Week 2022: Long Life For All

First COVID-19 Breath Test Gets FDA Authorization

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In this episode, Ayesha discussed BioNTech’s new collaboration with Matinas BioPharma to explore the company’s lipid nanocrystal (LNC) delivery technology for mRNA vaccines. LNC structures are more stable than the lipid nanoparticle technology used in the current COVID-19 mRNA vaccines. Learn about how BioNTech hopes to leverage Matinas’ LNC platform to develop improved mRNA vaccines, including the possibility of orally administered vaccine formulations. 

The editorial team also talked about Pfizer’s acquisition of RSV antiviral therapeutics company ReViral Ltd. in a $525 million deal. Pfizer made the purchase to help expand its RSV portfolio, which currently includes a candidate RSV vaccine that received breakthrough therapy designation from the FDA for the prevention of RSV in individuals 60 years of age and older. With the acquisition, Pfizer is looking to expand its infectious disease portfolio after the great success of its COVID-19 program.

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BioNTech Partners with Matinas BioPharma to Develop New Delivery Technology for mRNA Vaccines

Pfizer to Acquire RSV Antiviral Developer ReViral in $525 Million Deal

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In this episode, Xtalks is marking World Parkinson’s Day (April 11) and Parkinson’s Awareness Month, which are observed every year to help raise awareness about the disease and the individuals living with it. To learn more about new Parkinson’s disease research, Ayesha discussed a new study by researchers at Rush University Medical Center that shows statins may help decrease the risk of parkinsonism in older adults. Hear about how parkinsonism relates to Parkinson’s disease and how the neuroprotective effects of statins could prevent Parkinson’s and related conditions.

The editorial team also discussed a new rapid molecular test developed by UK-based Genedrive PLC that can help physicians select the best antibiotic to treat babies with to prevent hearing loss. Gentamicin is the preferred treatment for newborns with infections like sepsis but about one in 500 babies have a genetic variant that makes them susceptible to gentamicin-induced hearing loss. Find out how the new genetic test can produce results in less than half an hour to help clinicians quickly determine the best course of treatment, and its rollout across a couple of NICUs in England.

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Parkinson’s Awareness Month: Statins May Lower Parkinsonism Risk in Older Adults 

Genedrive’s Genetic Test Can Prevent Hearing Loss in Babies Through Personalized Treatment 

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In this episode, Ayesha shared insights she obtained from experts at NIH’s National Heart, Lung and Blood Institute (NHLBI) about clinical trial diversity. The panel of experts outlined some of the challenges in recruiting participants from minority and disadvantaged socioeconomic backgrounds, and talked about an NHLBI initiative based on community outreach that helped recruit more participants from traditionally underrepresented groups for COVID-19 vaccine trials. 

The editorial team also talked about the theme of this year’s World Health Day 2022, which is “our planet, our health.” The theme relates to new WHO data that shows most of the world is breathing polluted air. This is of great significance and concern as environmental causes are a leading cause of death worldwide. Learn about the initiatives and updated guidelines that the WHO has issued to help address the worsening quality of air globally, and hear our team’s thoughts on how environmental responsibilities should be shared.

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Xtalks Voices: NIH Experts Share Insights on Increasing Clinical Trial Diversity

World Health Day 2022: WHO Data Shows 99 Percent of People Breathe Poor Quality Air

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In this episode, Ayesha discussed Pfizer’s voluntary recall of several lots of its blood pressure medication Accuretic and two generic versions of it due to higher than acceptable levels of a carcinogenic nitrosamine compound. The recall affects lots produced between November 2019 and March 2022. The editorial team discussed the increasing frequency of recalls of commonly prescribed drugs like blood pressure and diabetes medications. Should companies and regulators share more information about the steps being taken to address the issue of drug impurities?

The editorial team also talked about Jazz Pharmaceutical’s new $100 million manufacturing facility in the UK dedicated to the production of cannabis-based medicines. This includes the company’s bestselling epilepsy drug Epidiolex, which is the first FDA-approved cannabis-based medication. Construction on the facility has commenced and Jazz says it is committed to it being environmentally sustainable at all stages of development and use. Find out how Jazz is going green with its new cannabis-based drug manufacturing facility. 

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Accuretic Blood Pressure Drug and Two Generics Recalled by Pfizer Over Carcinogen Impurities

Jazz Pharma Announces $100 Million “Green” Manufacturing Plant for Cannabis-Based Medicines

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In this episode, Ayesha shed light on National Colorectal Cancer Awareness Month by talking about a new colon cancer screening campaign from Exact Sciences that features a TV ad with Katie Couric. Couric, who is a long-time advocate of colon cancer screening after her husband passed away from colon cancer over 20 years ago, continues her mission to help raise awareness about the importance of early screening for the disease. Exact Sciences’ campaign is appropriately called “Mission to Screen” and includes a TV commercial featuring Couric and her daughter, along with other people that Couric is seen speaking to about their reasons for screening for colon cancer. The ad highlights Exact Sciences’ Cologuard, a DNA-based stool test for colon cancer detection.

The editorial team also learned about Alnylam Pharmaceuticals’ lawsuits against mRNA COVID-19 vaccine makers Pfizer and Moderna over patent infringements. Alnylam claims it invented the lipid nanoparticle delivery technology used in the vaccines and is seeking “fair compensation” for its use. Moderna hit back at Alnylam, accusing it of “blatant opportunism” and saying that it has worked for years on a different version of the RNA delivery technology. The editorial team said it was difficult to take sides in this case without all of the evidence/information, but it isn’t difficult to “believe” Moderna as it has been developing RNA vaccines for over a decade.

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Alnylam Files Lawsuits Against Pfizer and Moderna Over Patent Infringement of RNA Delivery Technology

Exact Sciences and Katie Couric Partner for Colon Cancer Awareness Month with Cologuard TV Ad

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In this episode, Ayesha talks about new revelations about how Johnson & Johnson funded studies in the early 1970s that involved injecting prisoners in a Pennsylvania jail, most of whom were Black, with asbestos. The company wanted to compare the effects of asbestos versus talc, one of the main ingredients in Johnson & Johnson’s baby powder, on the skin. The company says it regrets backing the human asbestos experiments but says such human testing was common back then. The editorial team discussed Johnson & Johnson’s ongoing legal battles over its baby powder and how it could have better handled the recent revelations by not having made excuses for the asbestos studies.

The editorial team also discussed a new medical imaging device from Swift Medical for digital wound care and other skin conditions. The device fits on top of the camera of a cell phone and uses advanced imaging technology to capture “beneath-the-skin” images of the skin. Swift Medical says the device was designed to make wound care accessible for all patients, regardless of skin type and at any beside or clinical location. The images can be accessed by healthcare providers through an accompanying phone app to allow for remote monitoring and care. The team discussed the significant prevalence of chronic wounds, particularly associated with chronic conditions like diabetes, and how the device offers a great means of accessing information and care right from a cell phone. 

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Johnson & Johnson Remorseful Over Funding Human Asbestos Experiments, But Says They Were Common in the Past

Swift Medical Reveals New Imaging Device for Remote, Digital Wound Care

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In this episode, Ayesha spoke about some of the top women leaders in life science industries in celebration of International Women’s Day. While women remain underrepresented in STEM and life science industries, there are more women in leadership positions at pharmaceutical, biotechnology and medical device companies than ever before. Studies also show that women’s leadership training programs provide effective training for women seeking executive-level positions. The editorial team also shared some of their experiences and insights as women in the life sciences. 

The editorial team also learned about the FDA approval of a new CAR T cell therapy developed by Johnson & Johnson and Legend Biotech for the treatment of relapsed or refractory multiple myeloma. The drug, called Carvykti, is administered as a single infusion and indicated for patients who have not responded to previous treatments. The cell therapy has a list price of almost half a million dollars due to the high development costs of cell therapies, but makers say the clinical benefit they offer is worth the price. Most insurers and Medicare will cover the cost of Carvykti.

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Looking at Women’s Leadership in Life Science Industries on International Women’s Day

Johnson & Johnson’s Carvykti Becomes Second FDA Approved Cell Therapy for Multiple Myeloma

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In this episode, the editorial team discussed Rare Disease Day which is celebrated every year on February 28 (or February 29 in leap years). This year’s theme was “Share Your Colours,” where individuals with rare diseases were encouraged to share their experiences and aspirations to help raise awareness. The campaign from rarediseaseday.org included a touching video in which patients with rare diseases shared their stories. The editorial team discussed the encouraging growth seen in recent years in rare disease clinical research in the life science industries, providing hope for improved diagnosis, care and treatments for patients with rare diseases.

To mark the end of Black History Month, the team also talked about the underrepresentation of Black people in clinical trials. Although Black people are disproportionately affected by certain diseases due to a combination of socioeconomic and genetic factors, their rates of participation in clinical trials remain concerningly low. In the US, Black people only constitute five percent of all clinical trial participants. Studies show historic medical mistrust among Black people for healthcare systems is the major barrier to trial participation, along with socioeconomic barriers and a lack of patient education. Community outreach and active engagement by the medical and scientific communities are key to improving clinical trial participation among Black people.

This week’s Xtalks Life Science Podcast was sponsored by Elligo Health Research.

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Sharing Colours on Rare Disease Day 2022

Why Black People Remain Underrepresented in Clinical Trials

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In this episode, Ayesha discussed BioNTech’s new modular mRNA factories, called the BioNTainer, that are destined for Africa to help boost COVID-19 vaccine supplies on the continent. The modular production units are housed in containers that come equipped with raw starting materials and state-of-the-art technology for producing mRNA-based vaccines from start to finish, except for the fill-and-finish step, which will be carried out by local manufacturers. Despite most African leaders welcoming the container factories, there is some controversy over BioNTech’s “paternalistic” control over production of its vaccine, especially since it continues to resist calls for patent waivers for its vaccine.

The team also talked about Eli Lilly’s new COVID-19 monoclonal antibody bebtelovimab that received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) indicated for patients with mild to moderate COVID-19 who are at risk of progressing to severe disease. The treatment replaces Eli Lilly’s previous monoclonal antibody cocktail of bamlanivimab and etesevimab, which was pulled by the FDA over a lack of effectiveness against the Omicron variant. Lilly’s new monoclonal antibody has shown neutralizing activity against Omicron in lab studies so far. The US Department of Human Health Services (HHS) is making it available to patients free of charge. The team discussed how quickly the new monoclonal antibody was developed, showing that companies like Eli Lilly are continuing to work on new iterations of COVID-19 treatments and vaccines in the face of new emerging variants.

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BioNTech Unveils the BioNTainer, a Modular mRNA Vaccine Factory to Help Production in Africa

FDA Authorizes Eli Lilly’s Bebtelovimab Which Demonstrates Activity Against Omicron

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In this episode, Ayesha discussed the NHS’s recommendation of Libmeldy, a gene therapy for the treatment of the rare disease MLD, which is officially the world’s most expensive drug with a list price of almost $4 million USD. The drug was developed by Orchard Therapeutics and the NHS was able to negotiate a greater discount on it with the company so that it can offer it to patients in England. Libmeldy was initially rejected by the drug price watchdog NICE in England over its exorbitant price. The editorial team discussed the high costs associated with orphan drugs and how both governments and pharma companies must work together to make them accessible to patients. 

The team also talked about a digital risk report that revealed the existence of significant cybersecurity vulnerabilities among the world’s top pharma companies. These include breaches and leakages of items like email addresses, passwords and even credit/banking information. Moreover, a significant percentage of breaches and record exposures occurred after 2020 and worsened in 2021 during the height of COVID-19 vaccine distribution efforts. Widespread cybersecurity breaches can lead to high-level attacks such as ransomware or coordinated disinformation campaigns. The team discussed how cyberattacks could hit almost every aspect of a pharma company’s operations, from R&D through to supply chains, and how this necessitates greater investments in cybersecurity infrastructure.

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UK’s NHS Backs World’s Costliest Drug Libmeldy for the Treatment of Rare Disease MLD

New Report Finds Whopping Increase in Pharma Cybersecurity Threats

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In this episode, Ayesha talked about a new at-home blood pressure monitor developed by Inbody that can track blood pressure in real time. The device uses the automated oscillometric method, commonly used in clinical settings now, to generate mean arterial pressure and calculate systolic and diastolic blood pressure from it using an algorithm. The device has a one-touch cuff and can be synced to Inbody’s mobile app, which allows users to access a digital health report outlining their blood pressure readings. This can help identify blood pressure fluctuations that could be indicative of heart conditions. The team discussed the convenience of at-home health monitoring and how it can allow individuals to better manage their health.

The editorial team also discussed Eli Lilly’s nearly $1.5 billion investment into building new manufacturing facilities in the US and Ireland. The pharma giant said the investment will allow the company to expand its manufacturing capacities, particularly in light of new therapeutics it is developing in areas including Alzheimer’s, diabetes, cancer and autoimmune conditions. The pharma giant is anticipating an FDA approval for its Alzheimer’s drug donanemab this year. The new US site will be in North Carolina and the Irish plant will be in Limerick, both home to institutes, universities and companies involved in STEM-based research.

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InBody’s New At-Home Blood Pressure Machine Allows for Real Time Monitoring

Eli Lilly Announces Nearly $1.5 Billion Investment into New Manufacturing Facilities in North Carolina and Ireland

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In this episode, Ayesha talked about the recent FDA approval for Immunocore’s Kimmtrak for the treatment of a rare type of eye cancer called uveal melanoma. Not only has the treatment become Immunocore’s first commercial product, but it has also become the first approved treatment for uveal melanoma and the first ever approved T cell receptor (TCR) therapeutic. Kimmtrak is priced at $400,000 per treatment course, and Immunocore has created a program to help make it accessible to patients. The editorial team discussed that while it is encouraging that therapeutic development in rare disease research has been increasing, the high cost of the treatments can be a significant barrier to access.

The editorial team also discussed how Pfizer and Moderna have commenced trials for their respective omicron-based vaccines. The companies announced that studies for their respective omicron targeting boosters had begun, and Moderna dosed its first trial participant last week. Given omicron’s significantly heightened transmissibility compared to other SARS-CoV-2 variants, and the reduced effectiveness of the current versions of the vaccines against it, the team discussed that it made sense to have an omicron-specific booster for better individual protection and to help curb transmission. 

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Immunocore’s Kimmtrak Gets FDA Approval as First Treatment for Rare Eye Cancer and First T Cell Receptor Therapeutic

Pfizer and Moderna Begin Trials for Omicron Targeting Vaccines

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In this episode, Ayesha discussed Gilead Science’s lawsuit against a network of distributors selling counterfeits of the company’s best-selling HIV drugs Biktarvy and Descovy. The drugs were being sold in pharmacies across several states. Gilead said it had been working with the US Marshals and local law enforcement to conduct seizures of over 85,000 bottles of the counterfeit drugs. Gilead says it’s taking action to ensure the counterfeits are removed from circulation. The editorial team talked about the significant dangers of counterfeit drugs with respect to patient safety and that stricter regulations around tracking and audits at pharmacies should be implemented to prevent the distribution of counterfeit products.

The editorial team also discussed Menarini Diagnostics’ new PCR-based COVID-19 test that can detect all of the variants of SARS-CoV-2, including Omicron. 

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Gilead Sues Distributors Selling Counterfeit HIV Drugs

Menarini Diagnostics’ New COVID-19 Test Detects Variants Including Omicron

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In this episode, Ayesha talks about a new study from UCSF that shows how physical activity can maintain brain health in older individuals. The research shows that exercise increases levels of synaptic proteins in the brain involved in maintaining and strengthening neuronal connections. The researchers also found these proteins could be protective even in people with dementia and other neurodegenerative diseases like Alzheimer’s. The team talked about the benefits of moderate exercise like walking, and agree that even small steps can make a big difference!

The editorial team also discussed a new cardiac mapping system developed by Abbott that received clearance from the FDA for the treatment of cardiac arrhythmias. The device integrates the company’s proprietary mapping technology, which allows for the generation of more accurate electrograms of the heart. This helps better identify the precise location of an arrhythmia to be treated with catheter ablation therapy. Developing more powerful imaging tools is key to improving the diagnosis and treatment of heart conditions like cardiac arrhythmias.

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Abbott’s New Cardiac Mapping System Gets FDA Clearance for Treatment of Cardiac Arrhythmias

Study Shows Exercise Can Strengthen Neural Connections in the Aging Brain to Maintain Cognitive Health

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In this episode, Ayesha discussed a new blood test developed by researchers at the University of Oxford that can detect cancers and even if they’ve metastasized. The test is based on measuring metabolites produced by tumor cells in blood samples using nuclear magnetic resonance (NMR) spectroscopy. The researchers found that the test could identify cancer among healthy people, those with localized cancer and individuals with cancer that has metastasized. The test could help detect cancers even before the use of conventional imaging-based methods.

The editorial team also discussed Bayer’s commitment to 100 percent green packaging for its consumer products by 2030. The target is part of the company’s sustainability program, which includes shifting to renewable energy sources and sustainably sourcing recyclable and reusable paper materials. Bayer’s most popular consumer products like Aspirin, Aleve and Claritin will all have green packaging by the target year, which will also include recycling information that is consumer friendly. Other pharmaceutical companies like AstraZeneca, GSK and Biogen also have similar sustainability programs, reflecting the growing awareness of the pharmaceutical industry’s large carbon footprint and the importance of efforts to reduce it.

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Cancer Blood Test Developed by University of Oxford Researchers Can Detect Metastasis

Bayer Commits to 100 Percent Green Packaging by 2030

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In the first episode of 2022, Ayesha provided updates on Omicron and COVID-19 vaccine boosters. The FDA expanded authorization of booster doses of Pfizer’s COVID-19 vaccine to youth between 12 and 15 years of age, a third dose for immunocompromised children between five and 11 years old and a shorter wait time to get a booster for individuals 12 and older. Meanwhile, the CDC reduced isolation and quarantine periods by half to five days. The team discussed the implication of these updates and despite the direness of the current situation, expressed hope in seeing the pandemic finally end.

Ayesha also discussed some of the predicted trends in the life sciences in 2022. These include the continued promise of RNA-based vaccines and therapeutics like RNA editing for the treatment of various conditions including rare genetic diseases. Digital transformation in healthcare is another significant trend that will continue in 2022. Tools like wearable technologies, electronic data capture and integration of AI approaches are enabling the digital transformation of healthcare to help improve and revolutionize patient care.

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Key Trends in the Life Sciences to Look Forward to in 2022

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In this episode, which is the last episode for the year (the team will be back in January!), Ayesha discusses the FDA approval of Biohaven’s intranasal spray Zavegepant indicated for the acute treatment of migraines in adults. The drug is similar to the company oral dose tablet (ODT) Nurtec but is the first CGRP receptor antagonist in a nasal spray formulation. Some of the editorial team members shared their experiences with migraine headaches, and talked about the pros and cons of an intranasal spray for helping treat them.

The team also talked about the first results from an early-stage trial evaluating Moderna’s new mRNA-based influenza vaccine. After the success of its mRNA COVID-19 vaccine, the company got to work on a quadrivalent vaccine against influenza. The trial results showed that the vaccine had no serious safety concerns and that it elicits an immune response against the four different strains of the influenza virus in the vaccine. The results of this were a bit mixed as there were greater levels of neutralizing antibodies against influenza A strain antigens than influenza B strain antigens. Moderna is also planning for a triple target vaccine against COVID-19, influenza and RSV.

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Biohaven Eyes FDA Approval for Second Migraine Drug Zavegepant After Promising Trial Results

Moderna Reveals Positive Results for its mRNA Influenza Vaccine

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In this episode, Ayesha discussed statements from Moderna and Pfizer regarding Omicron and the need for new variant-specific boosters. Moderna’s CEO sparked concerns when he said the current vaccines likely won’t be effective against Omicron, while Pfizer’s CEO said vaccines for COVID-19 will likely be needed for many years. The editorial team discussed the impact of these comments as they were relatively premature given that not much is known about Omicron yet, such as its transmissibility and potential for immune evasion. It’s important for companies to improve on their communications to ensure they’re evidence-based and don’t evoke unnecessary panic among people.

The team also talked about a new hepatitis B vaccine from VBI Vaccines that received FDA approval for adults. The vaccine is the first three-antigen hepatitis B vaccine approved in the US. While hepatitis B vaccination is recommended for all infants at birth now, this only began in the early 1990s. About 25 percent of adults in the US are not vaccinated for hepatitis B. The global hepatitis B vaccine market is expected to grow, particularly as several other hepatitis B vaccines were also approved by the FDA in the last couple of years. The World Health Organization (WHO) has laid out a goal to eliminate hepatitis B worldwide by 2030.

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Will the Current COVID-19 Vaccines Work Against Omicron? Pfizer and Moderna Spark Concern by Painting Bleak Pictures Prematurely

VBI Vaccines Gets FDA Approval for First Three-Antigen Hepatitis B Shot

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In this episode, Ayesha discussed Omicron, the latest SARS-CoV-2 variant of concern. The editorial team talked about the emergence of variants amid low vaccine uptake in some parts of the world owing to vaccine inequities and vaccine hesitancy. Omicron’s transmissibility, severity and the effectiveness of the current vaccines against it remain unknown. Amid border closures and travel bans being instituted by countries worldwide, the team agreed that the pandemic isn’t over yet and new variants may be inevitable, which is why vaccination and other protective measures such as masks, physical distancing and hand hygiene continue to be important to help mitigate transmission.

The team also talked about Sagent Pharmaceutical’s voluntary recall of several lots of its injectable seizure medication levetiracetam due to potential loss of sterility because of a container closure issue on the vials it comes packaged in. The affected lots were distributed this year and affect reserve sample vials. The writers discussed how companies need to pay closer heed to the quality standards of manufacturers producing the packaging components for their pharmaceuticals, as the packaging of a drug product is critical to its integrity.

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Omicron Designated as a Variant of Concern by WHO: What We Know About It So Far

Seizure Drug from Sagent Pharmaceuticals Recalled Over Faulty Seal

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In this episode, Ayesha discussed the first FDA-approved virtual reality treatment for chronic lower back pain. The virtual reality system is called EaseVRx and is developed by virtual reality medtech company AppliedVR. The non-invasive treatment system is self-administered and is designed for at-home use. It consists of a virtual reality headset, controller and breath amplifier, and has preloaded software with cognitive behavioral therapy (CBT) and behavioral skill-based content including exercises and lessons as part of the treatment plan. The editorial team discussed the novelty of virtual reality treatments for conditions like chronic pain and depression as well as the benefits of at-home treatments as they offer convenience and reduce burdens on patients and caregivers.

The editorial team also talked about Canadian CDMO Biovectra’s recent announcement of its plans to build a biomanufacturing facility for large-scale production of mRNA therapeutics, including mRNA COVID-19 vaccines. During the pandemic, only a handful of production sites continue to produce the vaccines, which has led to global shortages, delays and distribution inequities. To address this, Biovectra is set to build the first domestic large-scale mRNA production plant in Canada with financial backing from the Canadian government. The company plans to produce doses of the current COVID-19 mRNA vaccines and also be equipped to produce mRNA therapeutics for future projects and potential health emergencies. 

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FDA Approves First Virtual Reality Pain Treatment

Biovectra to Build First mRNA Vaccine and Drug Manufacturing Plant in Canada

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In this episode, the editorial team had the opportunity to speak with Dr. Brett Wingeier, CEO of neuromodulation MedTech company Magnus Medical about the company’s Magnus System for the treatment of major depressive disorder (MDD). The neurostimulation device received breakthrough device designation from the US Food and Drug Administration (FDA) last month. The team heard from Dr. Wingeier about the challenges of treating depression and how neuromodulation shows clinical effectiveness for patients. Given this, he explained how the company decided to develop the Magnus System and described how it works. As a 20-year veteran in the field of neuromodulation, hear Dr. Wingeier’s insights into how the field continues to grow. 

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Magnus Medical’s Neurostimulation Technology Granted FDA Breakthrough Device Designation 

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In this episode, the editorial team discussed Pfizer’s new oral antiviral pill for the treatment of COVID-19. Pfizer released data from an interim analysis of a Phase III trial evaluating the drug, which shows that it can reduce the risk of hospitalizations by almost 90 percent. It also prevented COVID-19 related deaths in the study. The results were so strong that an independent data monitoring committee and the FDA told Pfizer they could stop enrolling participants in the trial. Ayesha and the team discussed the convenience of an oral medication for COVID-19, and how such drugs appear to be more accepted than preventative vaccines among some circles of people.

The podcast also features a discussion on the recent FDA approval of AbbVie’s eyedrop for the treatment of presbyopia, or age-related deficits in near vision. The condition is currently treated with prescription “reading glasses” or contact lenses. With almost half of all adult Americans having the condition, there is a significant market for new treatments in the area. The editorial team discussed the advantages of an eyedrop over glasses, and how personal preferences may dictate what patients choose. 

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Pfizer’s COVID-19 Antiviral Pill Cuts Hospitalizations by 90 Percent and May Eliminate All Deaths

FDA Approves AbbVie’s Vuity as the First Eyedrop for Presbyopia

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In this episode, Ayesha discusses the FDA’s authorization of Pfizer/BioNTech’s COVID-19 vaccine for children between five and 11 years of age. The authorization was based on trial data that showed the vaccine was safe, well-tolerated and induced robust immune responses among children in this age group; side effects were generally mild to moderate. Amid concerns of the rare adverse event of myocarditis in children and adolescents following vaccination with mRNA vaccines, the FDA conducted its own benefit-risk analysis that showed the benefit of vaccination outweighs the risk of myocarditis. The editorial team discussed the positive trial data, the importance of vaccinating kids amid rising infections among younger children, as well as vaccine hesitancy among parents.

The team also learned about the FDA approval of Genentech’s new ocular implant drug delivery system, called Susvimo, for the treatment of neovascular, or wet, age-related macular degeneration (nAMD). The implant is surgically placed in the eye and injected with Genentech’s anti-VEGFA monoclonal antibody ranibizumab for continuous delivery. Compared with the current standard of care of near monthly intravitreal anti-VEGF injections, the ocular implant only has to be refilled every six months. The team discussed the convenience of the device, but also potential patient hesitancy over the surgery for its implantation.

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FDA Authorizes Pfizer/BioNTech COVID-19 Vaccine for Kids 5 to 11 

Genentech’s New Ocular Implant Drug Delivery System for Macular Degeneration Could Be a Game Changer

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In this episode, the editorial team discusses the FDA approval of Cyltezo as the first interchangeable biosimilar for AbbVie’s Humira. The approval lends to the growing Humira biosimilars market, which will take off in 2023 with Boehringer Ingelheim’s Cyltezo and biosimilars from Amgen, Merck and Alvotech. AbbVie has been facing a lot of heat over accusations of price gouging and patent abuses to block Humira biosimilars from entering the market. The team had an interesting discussion about public perceptions of generics and biosimilars versus their originals/reference products.

Ayesha also talked about a new gene silencing treatment for porphyria called Givlaari that received recommendation from England’s NICE after having been initially rejected by the health watchdog last year. Additionally, long-term results from a late-stage trial for Givlaari were recently released, which showed that the treatment provides sustained benefit and has a good safety profile. However, the team discussed the high cost of the treatment, which is a concern for patients in countries that don’t have some form of socialized healthcare.

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Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar 

Gene Silencing Porphyria Treatment, Givlaari, Finally Wins Over England’s NICE Amid Stellar Long-Term Data 

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In this episode, the editorial team talks about Moderna’s unwillingness to share its COVID-19 vaccine formula with other countries, namely low- and middle-income countries who continue to face issues accessing COVID-19 vaccines. The company said it would be more efficient for it to aim to produce more of the vaccines themselves to deliver to poorer countries. While developing countries continue to call for IP waivers on COVID-19 vaccines, and vaccine makers like Pfizer and Moderna resisting the calls, it’s important to note that it isn’t so easy to set up the specialized manufacturing facilities needed for production of mRNA vaccines. The team discusses these issues in the face of global vaccine inequities.

Ayesha also talked about Grammy award-winning singer Mary J. Blige’s efforts to help raise awareness about breast cancer during breast cancer awareness month this October. As part of her efforts, the entertainer teamed up with MedTech company Hologic, which is leading initiatives to promote equitable healthcare for women. Blige shared how breast cancer has personally affected her with the passing of her aunt from the disease, the problem of cancer not being discussed in Black communities and the fact that the disease has a 40 percent higher mortality among Black women compared to white women. Blige wants to help change this by raising awareness of the importance of early detection through annual mammograms, as well as increasing inclusion of Black women in clinical trials. 

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Moderna Unwilling to Share COVID-19 Vaccine Formula Amid Vaccine Inequities

Singer Mary J. Blige Partners with Hologic to Raise Awareness About Early Breast Cancer Screening for Black Women

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In this episode, Ayesha talks about World Arthritis Day, which is on October 12 every year, with this year’s theme being raising awareness about early diagnosis. In addition to timely diagnosis, there may soon be a preventative vaccine for inflammatory arthritic conditions such as rheumatoid arthritis. Researchers at the University of Toledo have developed a vaccine against inflammatory arthritis that has shown promise in animal models. The team talked about how a vaccine for arthritis is a somewhat novel and exciting concept and whether such a vaccine would be universally available, or only administered to certain demographics based on age and other risk factors for the disease. 

The editorial team also discussed Medtronic’s expanded recalls of the remote controllers for certain models of its MiniMed insulin pumps over cybersecurity concerns, as well as its 600 series insulin pumps due to a faulty retainer ring. The recalls affect almost half a million devices combined. The potential cybersecurity risk associated with the remote controllers could under- or over-deliver insulin to patients if an unauthorized user hacks into the system. The team discussed how there should be better contact methods and potentially centralized systems for drug and medical device recalls as many consumers may be left unaware that they have an affected product.

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How Researchers Stumbled Upon an Arthritis Vaccine Just in Time for World Arthritis Day

Medtronic Expands Two Insulin Pump Recalls, Including One Over Cybersecurity Concerns

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In this episode, Ayesha talks about the CDC’s updated guidance according to which the COVID-19 vaccines can be administered at the same time as the flu shot and other vaccines. The new guidelines comes after the federal health agency says there is now substantial data around the COVID-19 vaccines to show that it is safe to be administered alongside other vaccines. Additionally, studies show that immunization against influenza may protect against severe symptoms of COVID-19.

The editorial team also discussed the stellar trial results of Merck’s oral antiviral COVID-19 treatment molnupiravir. Last week Merck released interim data from a Phase III trial of the drug, which showed that it can cut the risk of hospitalizations and deaths by 50 percent. The results were so strong that the independent committee monitoring the trial suggested that the trial could be stopped. The team discussed the convenience of an oral pill treatment for COVID-19, and and how certain factions of the public appear to be less hesitant over COVID-19 treatments compared to COVID-19 vaccines.   

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CDC Says You Can Get Flu and COVID-19 Shots at the Same Time 

Merck’s Oral Pill Molnupiravir Cuts Risk of Hospitalizations and Deaths by Half in COVID-19 Patients 

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In this episode, Ayesha talks about the FDA’s new interactive quiz as part of its Bad Ad outreach program that targets misleading pharmaceutical promotions. Although the Bad Ad program is primarily directed towards healthcare providers, the general public can also anonymously report dubious ads to the FDA’s Office of Prescription Drug Promotion (OPDP), which runs the program. The new quiz is likely a part of more materials to come to help beef up the Bad Ad program, which has been receiving an increasing number of pharma ads for review over the last several years. 

The episode also features discussion about Pfizer and BioNTech’s announcement of the first trial results for their COVID-19 vaccine in young children between five and 11 years of age. The data shows that the vaccine is safe, well-tolerated and elicits robust immune responses in this age group. Despite the promising data, some parents may still be hesitant to vaccinate their young children according to a Kaiser Family Foundation survey. Hear about some of the factors that are influencing vaccine hesitancy among parents.   

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FDA Adds Quiz to Its Bad Ad Program to Combat Misleading Pharma Promotions

Pfizer Shares Positive Data on COVID-19 Vaccine for Young Children, But How Willing Are Parents to Vaccinate Their Kids?

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In this episode, Ayesha discusses the FDA’s pending decision on authorizing COVID-19 vaccine boosters for the general public. While an FDA vaccine advisory committee voted against boosters for individuals 16 years of age and older last week, the FDA is still working towards its final decision on the matter. At the same time, the advisory panel recommended offering third doses of the Pfizer COVID-19 vaccine to those 65 years and older, as well as high risk individuals. The team discussed the need for boosters in light of the Delta variant and concerns of global vaccine inequities, but agree that vaccine boosters are not out of the norm and generally to be expected at some point.  

The episode also features the ALS Association’s push for rapid FDA approval of Amylyx’s investigational ALS drug. The advocacy group cites the recent speedy approval of Biogen’s Aduhelm for Alzheimer’s disease, asking the FDA why similar regulatory flexibility is not being exercised for the ALS drug that could be life-changing for many ALS patients. The editorial team discusses the impact of the rapid approval of Aduhelm, as well as COVID-19 vaccines, as potentially driving changes in regulatory timelines, as more companies and patient groups may be demanding similar speedy approvals. 

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FDA Remains Mum on COVID-19 Vaccine Boosters, But Acknowledges Third Dose Improves Immunity

ALS Association Pressures FDA to Approve Amylyx Drug as Agency Cuts Phase III Trial Requirement

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With RNA being the popular new “it” molecule in genetic research, Ayesha discusses Eli Lilly’s new partnership with biotech company ProQR to develop RNA-based therapeutics in this episode. The $1.5 billion deal will see Lilly leverage ProQR’s proprietary RNA editing platform to develop targets of interest. The team discusses how the success of the mRNA COVID-19 vaccines have heightened interest in RNA-based therapies. 

The editorial team also talked about a new study that found walking 7,000 steps leads to a decreased risk of premature death among middle-aged adults by 50 to 70 percent. It turns out that the popularized “10,000 steps-a-day for good health” notion is no more than a mere myth as it is not an evidence-based recommendation. The new study provides a basis for the establishment of scientifically-backed guidelines for physical activities like walking.

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Eli Lilly Pursues RNA Editing in New Partnership with ProQR

How Many Steps a Day Should You Actually Be Taking? New Study Shows Less May Be More

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Knee replacements may soon be getting smarter with the world’s first smart knee implant. In this episode, Ayesha discusses a new personalized knee implant with integrated smart technology that recently received FDA clearance. Using sensors and cloud connectivity, it can help patients and practitioners monitor post-operative progress in real-time. 

The editorial team also talked about new data from a clinical validation study for an Alzheimer’s blood test that can predict the disease years before symptoms appear. The team discussed how useful this would actually be from a patient perspective, as there is no cure for Alzheimer’s and treatments are limited. 

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How the World’s First “Smart” Knee Implant Aims to Change Knee Replacement Recovery

New Study Shows Diadem’s AlzoSure Alzheimer’s Blood Test Can Predict Disease Years Before Diagnosis

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If 20 percent of the 250 million antibiotic prescriptions written globally each year are unnecessary, are there more drug-resistant superbugs in our future? In this episode, Sarah talks about the importance of paying attention to antimicrobial resistance (AMR) and how surveillance programs will be key to preventing the next pandemic.

The team debates when it’s appropriate to treat patients with antibiotics and discusses how bacterial infections are identified. They also talk about the link between serious SARS-CoV-2 infections and secondary bacterial infections and how the current COVID-19 pandemic has highlighted the importance of addressing AMR as a global threat to public health.

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Why Antimicrobial Resistance is a Silent Pandemic

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In this episode, Sarah presents three ways that Alzheimer’s trials will change now that Biogen’s Aduhelm (aducanumab) has been approved by the FDA. The team discusses whether placebo-controlled trials are still ethical and how ongoing dementia studies can manage patient attrition. Can trials pivot to allow patients to aducanumab as a background therapy?

The hosts also discuss how the price of aducanumab may limit patient access, and what it might take for payers to cover the cost of this pricey drug. 

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AAIC 2021: Six Ways the Approval of Aducanumab Will Change Alzheimer’s Clinical Trials

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In this episode, Ayesha discussed the US Food and Drug Administration’s (FDA) authorization of a third dose of the Pfizer and Moderna COVID-19 vaccines for immunocompromised individuals. These individuals would primarily include organ transplant recipients, as well as patients taking immunosuppressive drugs for conditions like cancer and HIV/AIDS. Many people with weakened immune systems have been shown to have either low antibody titers, or none at all, after receiving a standard two-dose regimen of the Pfizer and Moderna COVID-19 vaccines. The FDA said additional vaccine doses for the general public are currently unwarranted. The editorial team discussed whether COVID-19 vaccine boosters could become a norm depending on how the SARS-CoV-2 virus, and the pandemic it has caused, evolves.

FDA Authorizes COVID-19 Vaccine Boosters for Immunocompromised Individuals

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In this episode, Ayesha discussed a presentation at this year’s Alzheimer’s Association International Conference (AAIC) 2021 about the impacts of COVID-19 on cognitive health. The study, conducted at New York University Langone Health, found that in cognitively normal COVID-19 patients that experienced the neurological symptom of confusion due to toxic-metabolic encephalopathy (TME), levels of serum biomarkers associated with neuroinflammation, neuronal injury and Alzheimer’s disease (such as phosphorylated Tau 181 and neurofilament light protein) were higher than in patients that did not have TME. The strong correlation of these serum biomarkers with the presence of neurological symptoms in COVID-19 patients suggest that COVID-19 patients could experience an acceleration of AD/ADRD symptoms and pathology.

Ayesha also discussed another story about serum biomarkers for the early detection of pancreatic cancer. Immunovia, a Swedish biotech firm, has developed a nine-panel biomarker blood test that can be used for the detection of pancreatic in early stages. The company’s American subsidiary, located in Massachusetts, received approval for the test early this month and the Massachusetts Department of Public Health has already begun using it to test patients for the deadly cancer. The test evaluates a combination of immunoregulatory and tumor biomarkers. Early detection of pancreatic cancer is a significant unmet clinical need because the cancer is typically diagnosed in late stages when treatment options are limited and the disease is difficult to treat.

AAIC 2021: Insights into COVID-19 Impacts on Cognitive Health

Immunovia’s Pancreatic Cancer Blood Test is World’s First for Early Disease Detection

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In this episode, Sarah talked about attending the Alzheimer’s Association International Conference (AAIC) 2021 virtually this year and discussed increasing diversity in Alzheimer’s clinical trials as an important topic that was part of the conference. Black and Hispanic people are more likely to be diagnosed with Alzheimer’s compared to Caucasians. Sarah outlined the results of some studies shared at the meeting, including a study that revealed people of minority backgrounds would be more likely to participate in a trial if they were directly invited to participate by someone of their own race, and if a family member had the disease. Exclusion criteria could also inadvertently exclude potential participants based on race, warranting the need for trial designs that foster greater inclusivity, including outreach tools, to broaden recruitment.

Related to the theme of racial inequities in healthcare as well as the health and beauty industry, Ayesha discussed a recent lawsuit launched against Johnson & Johnson over its iconic baby powder by a Black women’s advocacy group. The group claims that the company engaged in targeted marketing of their baby powder to Black and Hispanic women, whilst knowing for decades about asbestos impurities in their product; the company has been facing thousands of individual lawsuits over the years over links to use of the baby powder and ovarian cancer and mesothelioma. As part of the lawsuit, the advocacy group is calling on Johnson & Johnson to rectify its past ad campaigns by creating new adverts that are equitable and have “corrective marketing” that warn Black women of the risks associated with the product.

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Diversity in Clinical Trials: Tackling the Issues in Alzheimer’s Research at AAIC 2021

Black Women’s Group Launches Lawsuit Against Johnson & Johnson Over Targeted Baby Powder Ads

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In this episode, Ayesha discusses a set of recommendations for use of the new FDA-approved Alzheimer’s treatment Aduhelm (aducanumab) published by an expert panel, which was shared at the Alzheimer’s Association International Conference (AAIC) 2021 this week. Ayesha and the team talked about the controversial approval of the drug, with lingering questions about its clinical benefit despite having the ability to reduce amyloid plaques as an anti-amyloid monoclonal antibody. It appears that clinicians and scientists in the field have embraced the treatment for the most part and are working towards developing clear guidelines and an infrastructure for the drug’s use in the goal of helping patients that could most benefit from the treatment.

The team also talked about Pfizer’s expanded recall of its smoking cessation drug Chantix, which now involves 12 lots. The recall is over the finding of higher than acceptable levels of a potentially carcinogenic nitrosamine in the batches of Chantix tablets produced between 2019 and 2021. Pfizer and the FDA maintain that the benefit of the medication outweighs the risks and that patients should continue using the drug, which is intended for short-term use. Long-term exposure to high amounts of nitrosamines has been linked to cancer-causing effects. The team talked about the increasing findings of impurities in drug manufacturing leading to similar recalls for other drugs recently, and how pharmacists and care providers should be more informed about them to help patients navigate the recalls.

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AAIC 2021 Coverage: Expert Panel Unveils Recommendations for Biogen’s Aduhelm

Chantix Recall: Pfizer Expands Withdrawal of Smoking Cessation Drug Over Carcinogen Concerns

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In this episode, Ayesha talks about the misleading headlines that ensued after WHO chief scientist Dr. Soumya Swaminathan made comments in a press briefing about mixing and matching COVID-19 vaccines and how there is currently no data to support additional doses and boosters at this time. News agencies like Reuters were at the helm of the misleading headlines, which took the comments out of context, stating that mixing and matching vaccines was outright dangerous. The team discussed the responsibility of media outlets to report information objectively and without sensationalist, clickbait headlines, and how the WHO can do a better job with its messaging.

The team also learned about a new, first-of-its-kind saliva test for measuring glucose levels in diabetic patients. The test was developed by researchers at the University of Newcastle in Australia and involves a strip with a glucose biosensor. Users simply lick the strip and insert it into a glucose monitor. The needle-free, non-invasive test is a welcome alternative to being pricked with a lancet everyday for testing, helping make the injection experience pain-free and far less anxiety-inducing. 

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Researchers Develop World’s First Saliva Test for Diabetes

Misleading Headlines Lead to Confusion Over WHO Comments on Boosters and Mixing and Matching COVID-19 Vaccines

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In this episode, Ayesha talks about Nestlé’s marketing of Seres Therapeutics’ oral microbiome drug for recurrent C. Difficile infection (CDI). CDIs are the leading cause of hospital-acquired infections in the US, with recurrence being a common problem. It typically develops after the use of antibiotics which can wipe out the gut’s healthy bacteria. Seres’ microbiome drug SER-109 aims to restore the healthy bacteria via an oral capsule that contains a protective species of gut bacteria. Nestlé has been a big player in the gastrointestinal space and first partnered with Seres in 2016. The latest venture of the partnership will have the food and beverage giant utilize its global pharmaceutical business Aimmune Therapeutics to take on the role of lead commercialization party for the oral microbiome drug.

The team also discussed the World Health Organization’s (WHO) adding IL-6 receptor blockers to its treatment guidelines for severely and critically ill COVID-19 patients. This includes IL-6 blockers from Roche (Actemra) and Sanofi (Kevzara). While IL-6 receptor antagonists initially met with mixed results in COVID-19 trials, recent data suggests it can cut improve survival outcomes in critically ill patients. The WHO also called on manufacturers to reduce the cost of the IL-6 receptor monoclonal antibodies to help increase access to the drugs in low- and middle-income countries.

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Nestlé to Market Seres’ Oral Microbiome Drug for C. Difficilev 

WHO Calls on Roche and Sanofi to Lower Costs for Life-Saving COVID-19 Treatment 

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In this episode, Ayesha talks about the launch of a digital marketing campaign for the first FDA-approved therapeutic video game to help treat ADHD. The video game, called EndeavorRx, is installed as an app on smart phones and tablets. It was developed by digital medicine company Akili Interactive. The game is available by prescription and is indicated for children eight to 12 years of age with primarily inattentive or combined-type ADHD who have a demonstrated attention issue. Akili launched the first ad campaign for the game on Instagram and is also looking to advertise on other social media outlets. While the game is to be used alongside traditional ADHD medications, it could lower medication doses and serve as a promising non-pharmaceutical alternative for ADHD treatment in children.

The team also discussed growing reports of how some women have been experiencing changes in their menstrual cycle following COVID-19 vaccination. While the link between the vaccines and irregular periods have not been studied, experts say the changes are short-term and are not of concern. In fact, vaccination against influenza and HPV are known to lead to temporary menstrual changes. The COVID-19 vaccines may trigger similar changes due to activation of immune cells in the uterus or inflammation, or just simply due to stress around getting vaccinated. Until a causal link is shown, the group agreed that people should not be taken in by conspiracy theories about menstrual cycle changes as related to fertility and pregnancy; the vaccines have been shown to have no effect on the latter. 

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Akili Launches Digital Ad Campaign for First FDA-Approved ADHD Video Game

Why the Potential Effects of COVID-19 Vaccines on the Menstrual Cycle Are Not Concerning

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In this episode, Ayesha talks about a peripheral nerve stimulation system for chronic pain developed by biotech company NeuraLace that received 510(k) FDA clearance last week. The device uses electromagnetic induction technology to directly target nerves damaged from injuries like accidents, surgery and burns among others. The goal is to stimulate damaged nerves involved in the body’s natural pain-relief pathways, helping alleviate pain at the source rather than trying to mask it as most other neuromodulatory and pharmacological methods do. The device received FDA 510(k) clearance, allowing for marketing of the system before its final approval.

The team also discussed AstraZeneca’s legal troubles and how it won in the latest hearing of a lawsuit launched by the European Commission over failure to deliver on the promised number of doses of its COVID-19 vaccine to the EU. The Commission filed the lawsuit against the drugmaker in April over not only failing to meet promised vaccine targets, but also over not making use of all its manufacturing plants as outlined in the contract. A Brussels court found that it does not have exclusivity or right of priority over contracting parties, and also dismissed other measures being sought by the Commission. The group talked about how almost every company with a COVID-19 vaccine has had manufacturing delays and difficulties in meeting global demands in this unprecedented crisis.

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NeuraLace’s Peripheral Nerve Stimulation System Wins FDA Clearance for Chronic Pain 

AstraZeneca Prevails in EU COVID-19 Vaccine Lawsuit 

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In this episode, Ayesha discusses the results of a recent study that show Amazon’s Halo app can accurately estimate body fat percentage with results comparable to traditional DXA testing. The app has built-in AI algorithms that analyze images taken from a user’s smartphone, which are used to build a 3D model of the body and generate an estimate of body fat percentage within seconds. The app is easy to use and offers users the convenience of assessing their body fat composition from the comfort of their homes, instead of having to go to a clinic and wait for several days or weeks for results. 

The team also talked about Regeneron’s monoclonal antibody treatment for COVID-19 that has been shown to reduce the risk of deaths by 20 percent among hospitalized COVID-19 patients in results from the UK RECOVERY trial. The treatment consists of two monoclonal antibodies that target the spike protein of SARS-CoV-2. The team discussed how it is still important to research effective treatments for COVID-19 despite having vaccines because of circulating variants, and the potential for new ones, as well as continuing high case numbers in some countries. Moreover, continuing to develop new technologies and treatments will be beneficial for other current and future infectious diseases.

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Study Shows Amazon’s AI-Powered Halo App Can Accurately Assess Body Fat Percentage

Regeneron’s COVID-19 Monoclonal Antibody Treatment First to Reduce Risk of Death in Hospitalized Patients

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In this episode, Ayesha talks about a new digital fabric fiber developed by MIT researchers. The fiber contains temperature sensors and memory devices that can sense, record, analyze and store digital health data. The polymeric fiber was designed with hundreds of microscale digital chips embedded into it and can be sewn into fabrics using a needle. Using AI approaches, the digital fiber can analyze temperature recordings and infer a user’s activity. It has the capacity to record and store all types of digital data, including movies and music, creating exciting possibilities for digital data capture, analysis, storage and sharing.  

The team also discussed the FDA’s recent authorization of Amazon’s direct-to-consumer (DTC) COVID-19 test. The PCR-based test can be bought online through Amazon without the need of a prescription. The test involves self-collection of nasal swab samples with the option of sample pooling. Consumers mail in the samples to Amazon, which are processed at laboratories the company set up for routine testing of its employees. Not only is the test a part of Amazon’s continuing COVID-19 pandemic efforts, but it is also a part of the company’s larger forays into health care, as the online retail giant recently launched Amazon Care, a virtual-first health care platform.

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MIT Researchers Develop World’s First Digital Fabric That Can Measure and Store Health Data

Amazon Gets Green Light from FDA to Sell COVID-19 Tests Directly to Consumers

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In this episode, Ayesha talks about new research from Australia showing that eating fruit could lower the risk of developing type 2 diabetes. Researchers at the Edith Cowan University’s (ECU) Institute for Nutrition Research in Perth, Australia found that consuming at least two servings of fruit a day was linked to an over one third lower odds of developing the disease. The same benefit was not seen for drinking fruit juice. This isn’t the first study that has found a link between fruit intake and a lower risk of type 2 diabetes. Fruit is loaded with fiber, vitamins, minerals and antioxidants that likely work together to offer significant health benefits.

The group also discussed Moderna’s COVID-19 vaccine manufacturing partnerships, including its latest deal with South Korea’s Samsung Biologics. As Moderna’s first authorized product, the company doesn’t have the manufacturing capacities to produce enough doses of its COVID-19 mRNA vaccine to meet global demands. Given this, CDMOs like Lonza and Catalent partnered early on with Moderna to manufacture millions of doses of the vaccine. And now with more manufacturing deals, Moderna has ambitiously pledged to produce up to 1 billion doses of its vaccine this year, and 3 billion by 2022. 

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Can Fruit Lower the Risk of Type 2 Diabetes?

Moderna Strikes Manufacturing Deal with Samsung Biologics for COVID-19 Vaccine Production

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