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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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 +...

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 +...

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...

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...