Xtalks Life Science Podcast

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

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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

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

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