BioCentury This Week

Lauren Martz, product development lead covering oncology and targeted therapies, breaks down why oral SERDs are a catalyst-rich approach for ER+ HER2- breast cancer. Steve Usdin, Washington regulatory analyst, reviews recent FDA setbacks including a Moderna refusal to file and a CRL to Disc Medicine and calls for accountability at CBER. Short, focused takes on trial positioning, competitive mechanisms, and regulatory fallout.

Selina Koch, neuroscience and psychiatry editor who interviews industry leaders. Steve Usdin, policy analyst focused on FDA and biomedical funding. Danielle Golovin, analyst tracking Series A and VC trends. They discuss 2025 Series A stabilization and which modalities drew funding. They debate how compounded Wegovy affects innovation and cover Congress defending NIH budgets. They explore serendipity versus engineering in psychiatric drug discovery.

Simone Fishburn, geopolitics and life‑sciences policy commentator; Selena Koch, editorial strategist on industry trends; Steve Usdin, policy and regulatory analyst; Lauren Martz, biopharma intelligence lead on RNA and renal. They unpack RNAi and antisense as 2026 catalysts. They cover cardiovascular Lp(a) trials, renal and neuromuscular readouts, obesity launches, and China’s new orphan drug exclusivity rule.

New rules in China will accelerate the country’s cell and gene therapy sector by reshaping how investigator-initiated trials are conducted and commercialized. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the new framework and why it will create a powerful incentive for deploying new gene and cell therapies.Executive Editor Selina Koch discusses which milestones she is watching in neurology in the year ahead, from psychedelics to Alzheimer's disease. Finally, Senior Biopharma Analyst Danielle Golovin discusses a pair of stories from BioCentury’s Emerging Company Profile series: one focused on Yale spinout Bexorg Inc., which is rethinking CNS drug discovery with a whole-human-brain model, and another on Elkedonia S.A.S., a French start-up aiming at ELK1 to reboot neuroplasticity in depression.View full story: https://www.biocentury.com/article/65818900:00 - Introduction03:14 - Speeding China's Innovation10:36 - Neuro Catalysts22:01 - NewcosTo submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The biotech bull is back, and buysiders believe this market has staying power for the first time in nearly five years. On a special episode of the BioCentury This Week podcast, Director of Biopharma Intelligence Stephen Hansen and colleagues discuss Hansen’s 2026 Public Markets Preview, which found interest rates, policy in Washington and fundamentals finally aligning and a wave of launches and M&A that could keep capital flowing into the sector.View full story: https://www.biocentury.com/article/658154#BiotechBullMarket #PublicMarkets #BiotechMA #IPOOutlook #FDApolicy00:00 - Introduction00:41 - Market Sentiment07:55 - Biotech's Next Wave14:47 - Lingering Concerns23:29 - IPOs26:47 - M&ATo submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Danielle Golovin, a Senior Biopharma Analyst specializing in induced proximity technologies, shares her insights on the evolution of next-generation targeting chimeras (TACs). She discusses the surge in publications driving this analysis and highlights specific innovations like lysosomal degraders. Steve Usdin, Washington Editor, dives into the political landscape surrounding drug pricing policies, including MFN legislation and its implications for the pharma industry. The duo also examines GSK's $2.2 billion acquisition of Rapt Therapeutics, discussing its strategic significance.

James Wong, a seasoned venture investor with deep expertise in biotech, discusses China's rapid strides in RNAi and the dynamics of valuation in global markets. Ingrid Yin, co-founder of MayTech Global Investments, shares insights on the public market outlook and the practical impact of AI in biotech. They explore the implications of 'China speed' in clinical trials and the changing landscape for startups, particularly in Japan. The conversation highlights the innovative ecosystems emerging in Asia and how local strategies are shaping the future of healthcare investments.

This week, Steve Usdin, Washington editor, and Lauren Martz, Biopharma Intelligence Executive Director, dive into the hot topics of biotech. They analyze significant deals from the J.P. Morgan Healthcare Conference, including a bispecific partnership between AbbVie and RemeGen. Usdin provides a bold policy outlook, warning of changes to drug pricing norms and potential FDA staff losses. Martz discusses approval trends for 2025, emphasizing innovations in drug delivery and the unique pressures affecting orphan drug programs. Tune in for new insights on biopharma dynamics!

The podcast kicks off with an optimistic outlook on biotech funding and approvals. However, uncertainties loom due to leadership changes at the FDA and NIH. The discussion highlights the impact on pediatric priority review vouchers and how global biotech is shifting focus to regions like China. Japan emerges as a promising opportunity with its strong science and venture capital growth. Meanwhile, Europe seeks to capitalize on U.S. regulatory instability to attract investment and talent, setting the stage for a dynamic 2026 in the biotech world.

This past year was an inflection point for biotech: The markets woke up, M&A and China had strong showings, drug development offered key trends, and new leadership at FDA shuffled the regulatory deck. On the latest BioCentury This Week podcast, BioCentury’s analysts make their picks for the biggest biopharma readouts, deals and regulatory and policy moves of 2025 and what they are forecasting for the year ahead.The analysts also recap biotech highlights of the past two weeks, including the $4.8 billion takeout of Amicus Therapeutics by BioMarin Pharmaceutical.View full story: https://www.biocentury.com/article/657933#BiotechOutlook2026 #BiopharmaTrends #BiotechMA #FDALeadership #ChinaBiotech00:00 - Introduction 02:31 - BioMarin's $4.8B Amicus Deal06:07 - Year-end Biotech Highlights16:37 - Analyst Picks and Predictions30:01 - Policy and Regulatory LandscapeTo submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text