BioCentury This Week

• Ep. 317 - Biotech IPOs, FDA-Stealth & Patent Threat

  There’s been a rare IPO filing on NASDAQ as LB Pharma looks to test the market during a year that has seen little activity among U.S. biotechs even as green shoots continue to appear on the Hong Kong stock exchange. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the market for biotech IPOs on NASDAQ and in Hong Kong.The analysts then assess FDA’s about-face on Stealth BioTherapeutics' Barth syndrome therapy, putting the decision in the context of a changing regulatory agency; and a BioCentury Guest Commentary that argues that the university-industry engine that drives U.S. innovation is under attack. Also mentioned on this week’s podcast: BioCentury’s 33rd Back to School package, which reimagines FDA; the upcoming 12th China Healthcare Summit in Shanghai; the evolution of dealmaking in China; and Annalisa Jenkins’ take on MHRA and the U.K. biotech ecosystem on The BioCentury Show.View full story: https://www.biocentury.com/article/656849#Biotech #IPO #Pharma #FDA #RareDisease #Biopharma #DrugDevelopment #HealthcareInnovation #HongKongIPO00:00 - Introduction 02:48 – LB Pharma Tests IPO Market07:01 – Hong Kong IPO Momentum09:53 – China Summit Preview13:40 – FDA Reversal on Stealth Bio18:15 – Bayh-Dole Clash & Innovation ThreatsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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• Ep. 316 - Trends in Pharma Deals

  BioCentury’s third annual analysis of pharma company deals finds that bispecifics and degraders are in, cell and gene therapies are out, and China is bringing much more than me-too assets to cross-border deals. On the latest BioCentury This Week podcast, BioCentury’s analysts assess a year’s worth of deals between pharmas and biotechs to tease out emerging trends.The analysts also discuss last week’s FDA approval of a vector-based immunotherapy from Precigen to treat a rare respiratory disease and whether the decision will set a precedent of more flexibility for rare disease therapies. They then take stock of recent translational coverage in BioCentury, including a report by Denali of a way to avoid a key safety issue of anti-amyloid-targeting mAbs.BioCentury’s Grand Rounds — Europe will take place in Cambridge, U.K., Sept. 17-19. The conference seeks to bridge academia, industry and investors for breakthrough innovation.View full Story: https://www.biocentury.com/article/656802#PharmaDeals #CrossBorderDeals #Bispecifics #TargetedProteinDegradation #RareDisease #Neurodegeneration00:00 - Introduction01:38 - Pharma Deals10:41 - Precigen14:40 - Denali's BBB Tech25:20 - Grand Rounds EuropeTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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• Ep. 315 - China Speed: Data, Deals, First in Class

  Dealmaking between Western and Chinese biopharmas has been one of the year’s bright spots, as a maturing biotech landscape in China converges with Western demand for innovative assets, driving record deal flow. At the same time, the Hong Kong stock exchange has emerged as the hottest market for biotech IPOs, at a time when the NASDAQ window remains shut.These themes will be in the spotlight at the 12th BioCentury-BayHelix China Healthcare Summit Oct. 22-24 in Shanghai. On this special edition of the BioCentury This Week podcast, a trio of biopharma leaders join BioCentury’s analysts to discuss the landscape: McKinsey's Franck Le Deu, former BD executive Ji Li, and HBM Holdings' Mike Patten.BioCentury, BayHelix and Insights Partner McKinsey & Company invite you to visit Shanghai for the 12th China Healthcare Summit at the St. Regis Shanghai Jingan. For more information, click here; to apply to join the 2025 Class of Presenting Companies click here. View full story: https://www.biocentury.com/article/656773#ChinaBiotech #CrossBorderDeals #HongKongIPO #BiotechInvesting #LifeSciencesFinance00:00 - Introduction02:09 – Key Trends06:03 – View from McKinsey13:36 – Evolution of Deal Landscape20:24 – Learning from China24:00 – China-China M&A & NewCosTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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• Ep. 314 - Prasad, Lilly Obesity, Acadia & Biosecure

  Phase III data from Lilly’s orforglipron in obesity fell short of investor expectations, but they appear to be enough to obtain approval and wide use. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss why the first-in-class oral small molecule GLP-1R agonist’s clean safety profile and clear manufacturing advantage over oral peptides give the product a leg-up in the market.They then discuss Vinay Prasad’s return to FDA after a brief hiatus, the revamped strategy of 32-year-old San Diego biotech Acadia Pharmaceuticals, and an attempt in the Senate to revive the Biosecure Act targeting China biotechs.Finally, the analysts preview this year’s Back to School package, which reimagines FDA. At a time of unprecedented change in government agencies, BioCentury’s 33rd Back to School asks what FDA could look like if it were reorganized from the ground up to create the regulator patients deserve and industry needs. View full story: https://www.biocentury.com/article/656727#orforglipron #CBER #VinayPrasad #AcadiaPharmaceuticals00:00 - Introduction00:49 - Prasad07:09 - Back to School12:29 - Lilly Obesity21:58 - Acadia's Comeback28:50 - Biosecure ActTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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• Ep. 313 - Lessons from FDA's Prasad. Plus: What's next for Novo, Bayer

  The ouster of Vinay Prasad after three months running FDA’s Center for Biologics Evaluation and Research could signal a reset is ahead for CBER. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what the latest shakeup at the regulatory agency says about what’s next for FDA.The analysts also assess two leading European pharmas: obesity and diabetes company Novo Nordisk, which named a new CEO last week while cutting its 2025 forecast, and Bayer, which is gearing up for launches and is revamping its pipeline to restart growth. Finally, they discuss the promising clinical data that’s reviving interest in masking technologies that conditionally activate biologics.View full story: https://www.biocentury.com/article/656649#FDA #CBER #NovoNordisk #ObesityDrugs #Bayer01:05 - Prasad's Ouster14:59 - Novo's New CEO21:14 - Bayer's Growth Strategy26:05 - Masked BiologicsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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