Xtalks Life Science Podcast

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 AttemptFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @XtalksInstagram: @XtalksFacebook: https://www.facebook.com/Xtalks.Webinars/LinkedIn: https://www.linkedin.com/company/xtalks-webconferencesYouTube: https://www.youtube.com/c/XtalksWebinars/featured

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 ClearanceNew Cardiac Biomarker Test Gets FDA ClearanceFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

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.For more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

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.For more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

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. 110For more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

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 For more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featuredSocial Post:

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 InnovationFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

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 FlashesFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

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 DevicesFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

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 PortfolioFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured