BioCentury This Week

• 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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• Ep. 312 - Biotech Progress Report

  A handful of encouraging signals is cause for cautious optimism for biotech headed into the second half of the year — companies have been able to parlay strong data into follow-on capital and M&A activity is picking up. That said, the IPO market continues to be closed and concerns about U.S. drug pricing and FDA stability continue to weigh on expectations for a robust near-term sector recovery.Special guest Megan Hooton from IQVIA Biotech joins BioCentury’s analysts on a special edition of the podcast to discuss key indicators of progress for the biopharma sector. Hooton is president of IQVIA Biotech, which sponsored this episode of the pod.View full story: https://www.biocentury.com/article/656614#biotech #biopharma #pharma #lifescience #BiotechTrends #ClinicalTrials #GeneTherapy #CellTherapy00:01 – Sponsor Message: IQVIA Biotech02:37 – Biotech Markets06:41 – Clinical Highlights10:26 – Insights from Meg Hooton23:10 – Advanced TherapiesTo 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. 311 - The Asia Deals Landscape, U.K. Biotech & More

  This week’s deal between GSK and Jiangsu Hengrui is a prime example of how Western biopharmas have begun to recognize the innovation and opportunities being fostered in China — and how it’s no longer all about fast followers.On the latest BioCentury This Week podcast, BioCentury’s analysts put the collaboration between GSK and Jiangsu Hengrui Pharmaceuticals, two of the most active cross-border dealmakers, into the context of East-West dealmaking over the past 30 months, assessing the innovation that is driving the rush to partner with biotechs in China, Japan, South Korea and beyond, and the types of companies looking to Asia for assets.BioCentury’s analysts also discuss Steve Bates’ outsized role in building the U.K. biotech hub, as he readies to take on a new role in the U.K. government. They examine new VC funds from Omega Funds and Brandon Capital, FDA’s new national priority voucher pilot program, and fallout from how FDA and  Sarepta Therapeutics handled the deaths of four patients who had received the biotech’s gene therapies. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/656592#biotech #biopharma #pharma #lifescience #EastWestDealmaking #ChinaBiotech #UKBiotech #FDAPolicy00:01 - Sponsor Message: IQVIA Biotech02:48 - Asia Deals Landscape17:32 - Steve Bates & U.K. Biotech25:46 - FDA's New Voucher Pilot31:01 - New VC Funds35:28 - SareptaTo 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. 310 - Sarepta & What's Next for Gene Therapy. Plus: Leading FDA's CDER

  Last week’s public disclosure that a gene therapy from Sarepta had caused a third death led FDA to ask the company to stop distributing its DMD gene therapy Elevidys, a move the biotech has resisted. The deaths, and disputes between FDA and Sarepta, raise questions about the future of AAV gene therapies, as well as the future of FDA’s platform technology designation. On the latest BioCentury This Week podcast, BioCentury’s analysts unpack the events surrounding Sarepta’s gene therapies and discuss how FDA, industry and patient groups should come together to learn the lessons from the tragic, avoidable deaths.BioCentury’s analysts also assess Monday’s appointment of Stanford professor and biotech executive George Tidmarsh to lead FDA’s Center for Drug Evaluation and Research, and check in on the latest trends in venture financings. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/656537#biotech #biopharma #pharma #lifescience #GeneTherapy #AAVTherapy #Sarepta #Elevidys00:01 - Sponsor Message: IQVIA Biotech02:03 - Gene Therapy17:59 - Leading CDER27:00 - Venture ReportTo 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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