BioCentury This Week

Two veteran biotech leaders are launching a new company with ambitions in the cardiovascular disease space. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the debut [https://www.biocentury.com/article/656856] of Corsera Health, a biotech led by John Maraganore and Clive Meanwell that is developing an AI-guided early risk assessment tool alongside dual-acting therapy that could stave off heart disease. The team then discusses how [https://www.biocentury.com/article/656885] FDA has been quietly positioning itself to disrupt the childhood vaccine schedule, as well as the effects of changes to the Medicare drug negotiation program that were included in the tax and budget bill Congress passed in July. View full story: https://www.biocentury.com/article/656897 [https://www.biocentury.com/article/656897] #Corsera #DiseaseInterception #CardiovascularHealth #HeartDisease #FDA #VaccinePolicy #Medicare #DrugPricing 00:00 - Introduction 01:26 - Maraganore, Meanwell Newco 09:17 - BioCentury's Back to School 14:51 - Vaccine Disruption at FDA 26:01 - Medicare Drug Negotiations To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text [https://www.buzzsprout.com/twilio/text_messages/1035190/open_sms]

There’s been a rare IPO filing [https://www.biocentury.com/article/656841] 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 [https://www.biocentury.com/article/656827]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 [https://www.biocentury.com/article/656831]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 [https://www.biocentury.com/article/656610] package, which reimagines FDA; the upcoming 12th China Healthcare Summit [https://conferences.biocentury.com/china-healthcare-summit] in Shanghai; the evolution of dealmaking [https://www.biocentury.com/article/656820] in China; and Annalisa Jenkins’ take [https://www.biocentury.com/article/656787] on MHRA and the U.K. biotech ecosystem on The BioCentury Show. View full story: https://www.biocentury.com/article/656849 [https://www.biocentury.com/article/656849] #Biotech #IPO #Pharma #FDA #RareDisease #Biopharma #DrugDevelopment #HealthcareInnovation #HongKongIPO 00:00 - Introduction  02:48 – LB Pharma Tests IPO Market 07:01 – Hong Kong IPO Momentum 09:53 – China Summit Preview 13:40 – FDA Reversal on Stealth Bio 18:15 – Bayh-Dole Clash & Innovation Threats To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text [https://www.buzzsprout.com/twilio/text_messages/1035190/open_sms]

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 [https://www.biocentury.com/article/656797] of more flexibility for rare disease therapies. They then take stock of recent translational coverage in BioCentury, including a report [https://www.biocentury.com/article/656772] 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 [https://conferences.biocentury.com/grand-rounds-europe] seeks to bridge academia, industry and investors for breakthrough innovation. View full Story: https://www.biocentury.com/article/656802 [https://www.biocentury.com/article/656802] #PharmaDeals #CrossBorderDeals #Bispecifics #TargetedProteinDegradation #RareDisease #Neurodegeneration 00:00 - Introduction 01:38 - Pharma Deals 10:41 - Precigen 14:40 - Denali's BBB Tech 25:20 - Grand Rounds Europe To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text [https://www.buzzsprout.com/twilio/text_messages/1035190/open_sms]

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 [https://conferences.biocentury.com/china-healthcare-summit]; to apply to join the 2025 Class of Presenting Companies click here [https://www.biocentury.com/events/presenting-nomination-form?utm_content=www.biocentury.com&utm_term=conferences.biocentury.com]. View full story: https://www.biocentury.com/article/656773 [https://www.biocentury.com/article/656773] #ChinaBiotech #CrossBorderDeals #HongKongIPO #BiotechInvesting #LifeSciencesFinance 00:00 - Introduction 02:09 – Key Trends 06:03 – View from McKinsey 13:36 – Evolution of Deal Landscape 20:24 – Learning from China 24:00 – China-China M&A & NewCos To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text [https://www.buzzsprout.com/twilio/text_messages/1035190/open_sms]

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 [https://www.biocentury.com/article/656677]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 [https://www.biocentury.com/article/656627], the revamped strategy [https://www.biocentury.com/article/656648] of 32-year-old San Diego biotech Acadia Pharmaceuticals, and an attempt in the Senate to revive [https://www.biocentury.com/article/656707] the Biosecure Act targeting China biotechs. Finally, the analysts preview this year’s Back to School package, which reimagines [https://www.biocentury.com/article/656610] 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 [https://www.biocentury.com/article/656727] #orforglipron #CBER #VinayPrasad #AcadiaPharmaceuticals 00:00 - Introduction 00:49 - Prasad 07:09 - Back to School 12:29 - Lilly Obesity 21:58 - Acadia's Comeback 28:50 - Biosecure Act To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text [https://www.buzzsprout.com/twilio/text_messages/1035190/open_sms]