BioCentury This Week

BioCentury's streaming commentary on biotech industry trends, plus interviews with KOLs.For three decades, BioCentury has helped biopharma executives and investors make business-critical decisions and build larger networks with peers across the innovation ecosystem.

  1. Ep. 340 - Obesity Data, Kymera & FDA Survey Results

    2025-12-16

    Ep. 340 - Obesity Data, Kymera & FDA Survey Results

    Obesity readouts continue to be hot for biotech with new top-line data from both injectable and oral therapies pushing the boundaries on efficacy. On the latest BioCentury This Week podcast, BioCentury’s analysts break down last week’s readouts from Eli Lilly, Structure  and Wave Life Sciences, and discuss a deal in the space by Pfizer. Lilly reported the latest for its triple agonist contender retatrutide for best-in-class weight loss, while strong Phase IIb data put Structure back in the oral GLP-1 race. Meanwhile, Pfizer added an oral GLP-1R agonist via a deal). Structure and Wave parlayed their data into follow-on cash, as did Kymera after posting data for its STAT6 program KT-621 that hints at a new era for degraders in immunology. The analysts then detailed the results of BioCentury’s industry sentiment survey on FDA, which found that politicization of the agency’s leadership, volatility and uncertainty are casting a long shadow over investor and drug developer sentiment. Finally, they discuss the impact of the congressional stalemate over the U.S. Small Business Innovation Research (SBIR) program. View full story: https://www.biocentury.com/article/657880 #ObesityDrugDevelopment #TargetedProteinDegradation #STAT6 #FDARegulation #SBIRFunding 00:00 - Introduction 01:45 - Obesity Data 12:17 - Kymera's Breakthrough 21:45 - FDA Survey Results 29:41 - SBIR Funding Stalemate To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

    33 min
  2. Ep. 339 - Biotech M&A, In Vivo CAR Ts & FDA Tumult

    2025-12-09

    Ep. 339 - Biotech M&A, In Vivo CAR Ts & FDA Tumult

    Fueled by cancer, obesity and cardiovascular deals, $1 billion-plus takeouts in biotech are at their highest level in a decade with three weeks to go in the year. On the latest BioCentury This Week, BioCentury’s analysts discuss the rise in large M&A deals and what the trends among the 37 acquisitions say about biopharma dealmaking. The analysts assess first-in-human in vivo CAR T data at the American Society of Hematology meeting from Kelonia Therapeutics, which showcase the promise of the modality and justify the growing pipeline. They also break down readouts from Praxis in developmental and epileptic encephalopathy from the American Epilepsy Society Annual Meeting and from Novo Nordisk, which presented full data at the Clinical Trials on Alzheimer’s Disease meeting on semaglutide’s failure to treat Alzheimer’s disease. Washington Editor Steve Usdin analyzes a roller-coaster week at FDA in which Richard Pazdur resigned as director of FDA’s Center for Drug Evaluation and Research and Tracy Beth Høeg became acting CDER director, a move that Usdin says will prompt staff departures, ease restraints on FDA leaders View full story: https://www.biocentury.com/article/657781 #BiotechMA #CARTTherapy #EpilepsyResearch #AlzheimersDisease #FDA 02:37 - Biotech M&A 06:39 - In vivo CAR T 10:08 - Semaglutide for Alzheimer's 16:17 - Praxis 22:11 - FDA To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

    35 min
  3. Ep. 337 - FDA’s Moving Goalposts & China’s Innovation Arc

    2025-11-25

    Ep. 337 - FDA’s Moving Goalposts & China’s Innovation Arc

    A baffling decision by FDA to issue a complete response letter for a pediatric medicine the medical community stood behind is just the latest example raising concerns that the agency is shifting the regulatory goalposts amid a lack of transparency. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains how the absence of advisory committee meetings at FDA is in part to blame for a lack of consistency in decision-making and divergence from decisions taken by other global regulatory agencies. VP and Editor-in-Chief Simone Fishburn then discusses the takeaways from Franck Le Deu’s guest commentary on how China’s biotech ecosystem is evolving, and whether government support for the sector is helping or hindering its overall health. BioCentury’s analysts also discuss whether conventional CRISPR therapies will ever be commercially successful, and what’s next for NLRP3 inhibitors to treat obesity following the first set of Phase II data for the class. We'd also like to invite our listeners to participate in our important survey about their experiences interacting with FDA. To take the survey, please go to BioCentury's FDA Sentiment Survey. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics. View full story: https://www.biocentury.com/article/657698 #FDARegulation #CRISPRTherapies #NLRP3Inhibitors #ChinaBiotech #DrugApproval 00:01 - Sponsor Message: Voyager Therapeutics 01:31 - FDA Sydnexis CRL 07:36 - CDC Vaccine Claims 09:55 - China’s Innovation Arc 16:49 - CRISPR Commercial Viability  26:39 - NLRP3 for Obesity To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

    34 min
  4. Ep. 336 - Cautious Optimism and M&A Momentum

    2025-11-22

    Ep. 336 - Cautious Optimism and M&A Momentum

    There is cautious optimism around continued M&A momentum and the public equities markets as biotech heads into the New Year. On a special edition of the BioCentury This Week podcast recorded in London during London Life Sciences Week, BioCentury’s Simone Fishburn and Stephen Hansen were joined by a trio of guests to discuss their key takeaways from the week and expectations for next year, including trends in M&A and creative deal structures for business development. The group also discussed the potential for biotech venture investing to make a comeback as a key asset class for LPs, especially in the U.K., as the government continues to encourage pension funds to invest more broadly. The three guests joining BioCentury included Luciana Griebel from law firm Morgan Lewis, James Critchley from PJT Partners, and Carmine Circelli from the British Business Bank. The podcast was recorded Nov. 19 on stage at the Victoria House in London as part of the 3rd Biotech CEO & Investor Reception. BioCentury’s next recording “on the road” will take place on the sidelines of the annual J.P. Morgan Healthcare Conference in San Francisco in January at the 11th East West Healthcare Reception hosted by BioCentury, Panacea Venture and Maytech Global Investments. View full story: https://www.biocentury.com/article/657686 #BiotechMandA #DrugDevelopment #VentureCapital #LifeSciences #LondonLifeSciencesWeek 00:00 - Introduction 02:24 - Market Recovery 08:02 - Growth and Influence 16:24 - Creative Dealmaking 21:40 - Role of CVRs 25:52 - Pension Funds and Venture Capital 30:09 - AI Bubble 34:17 - Accelerating Clinical Trials Morgan Lewis has prepared its materials for this podcast for general informational purposes only. They do not and are not intended to constitute legal advice. This podcast was recorded on Nov. 19. Morgan Lewis does not guarantee the accuracy or timeliness of the information contained in these materials and disclaims any obligation to advise you of any changes in the law. You should always refer to original source documents for complete information and consult directly with an attorney for advice, including on the latest developments in this rapidly changing area of the law. To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

    41 min
  5. Ep. 334 - Pazdur’s New FDA Role, SITC & China RNAi

    2025-11-18

    Ep. 334 - Pazdur’s New FDA Role, SITC & China RNAi

    Richard Pazdur took the top job at FDA’s Center for Drug Evaluation and Research after receiving vows that he would be leading CDER free from political interference. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the issues that could prove to be flashpoints between Pazdur and the heads of FDA and HHS, including personnel, RSV mAbs, puberty blockers and SSRIs. BioCentury's analysts assess bispecific innovation at the annual meeting of the Society for Immunotherapy of Cancer (SITC) and the growing field of companies pursuing RNAi, many of which have multiple unpartnered assets. Also featured in this week's episode: new funds from European VCs Medicxi and Sofinnova Partners, FDA’s new plausible mechanism pathway and the Trump administration’s “most favored nation” drug-pricing plan, which is turning out to be much more less onerous to drug companies than its original description suggested. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics. View full story: https://www.biocentury.com/article/657631 #RNAiTherapeutics #BispecificAntibodies #CD3TCellEngagers #MechanismOfAction #ImmunoOncology #PlausibleMechanismPathway #RegulatoryScience #ClinicalTranslation 00:01 - Sponsor Message: Voyager Therapeutics  03:08 - FDA's Richard Pazdur 13:08 - Plausible Mechanism Pathway 19:30 - Most Favored Nation 23:12 - Takeaways from SITC 28:05 - RNAi in China 33:21 - European VCs To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

    36 min

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BioCentury's streaming commentary on biotech industry trends, plus interviews with KOLs.For three decades, BioCentury has helped biopharma executives and investors make business-critical decisions and build larger networks with peers across the innovation ecosystem.

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