On this week’s episode, Sam Fazeli, John Maraganore, Nina Kjellson and Matt Gline dig into an in-depth discussion on the Trump Administration’s recent executive order aimed at lowering drug prices as part of a broader “Most Favored Nation.” The group discusses the 30-day ultimatum, the 180- days for negotiations and concerns that biotechs may not be adequately represented at the table. The conversation shifts to PBMs, noting that there’s growing support for banning spread pricing and requiring more reporting from PBMs. The group also touches on orphan drugs, sharing that there’s bipartisan support to exempt orphan drugs from IRA negotiations. Pharma’s talk of investment in AI is also overviewed. Next, the group discusses Recursion Pharmaceuticals’ Q1 pipeline reorganization and Galapagos reversing its decision to split in two. CMS guidance on IRA Part B negatively impacted Halozyme Therapeutics and J&J, raising questions about the classifications of subQ formulations as different drugs despite sharing the same active ingredient. The episode ends with a discussion on CytomX Therapeutics’ resurrection, including its stock price jump. *This episode aired on May 16, 2025.
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Episode 141 - May 9, 2025
On this week’s episode, Grace Colón, Josh Schimmer, Sam Fazeli, Tess Cameron, Eric Schmidt, and Yaron Werber kick off with a discussion on recent policy moves including the appointment of Vinay Prasad as the director of the FDA’s CBER division and nomination of Casey Means for U.S. Surgeon General, noting the impact on the XBI and uncertainty around vaccine gene therapy approvals. The group pondered what kind of regulator Prasad may be, predicting a stricter approach than his predecessor, Peter Marks. The conversation covered the shifting dynamics in vaccine approvals under the new FDA leadership, highlighting that delays like Novavax’s flu combo signal heightened scrutiny, with mRNA follow-ons likely to pass under stricter labels, while new vaccines face raised efficacy bars. On the policy front, Trump’s proposed “Most Favored Nation” drug pricing strategy raises alarms over a potential trillion-dollar hit to innovation and unintended consequences for U.S. drug prices. The conversation shifts to early data on Genocury’s in vivo CAR-T, PTC’s mixed Huntington’s disease results, and Krystal’s gene therapy for neuropathic keratitis. The episode concludes with a roundup of Q1 earnings results. *This episode aired on May 9, 2025.
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Episode 140 - May 2, 2025
On this week’s episode, Eric Schmidt and Sam Fazeli are joined by special guests Adam Feuerstein and Peter Kolchinsky to discuss the upward movement of the biotech market along with strong drug launches, deals, and net-positive Q1 earnings, all signaling things may be improving. Next, the group notes the FDA is unlikely to undergo significant reorganization and while this stability is reassuring, complacency should be avoided as headwinds persist. Despite the turmoil, the pharmaceutical industry remains resilient, as people prioritize their health and the need for medicine. The conversation shifts back to the new FDA leadership, highlighting Makary and RFK Jr.’s relationship, anti-vaccine rhetoric and the impacts this may have on vaccine trials. The group notes that at conversations at AACR suggest that large pharma is not worried about the FDA changes, while smaller companies have concerns. BridgeBio’s successful launch of Attruby was also discussed, highlighted as a positive trend for the industry. The conversation shifts back to vaccine uncertainty and the future of mRNA given the skepticism from healthcare professionals, illustrated by Moderna’s potential delays fortheir flu vaccine combo. The episode ends with Adam’s optimistic take on biotech’s recent turn toward stabilization. *This episode aired on May 2, 2025.
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Episode 139 - April 25, 2025
On this week’s episode, Daphne Zohar, Josh Schimmer, Tim Opler, John Maraganore, and Paul Matteis discuss the biotech market’s recent resurgence, and new FDA commissioner Marty Makary’s comments during his interview with former Fox News journalist Megyn Kelly. The discussion then shifts to the FDA’s reorganization, confusing return-to-work policies, and low morale at the agency, which resulted in slower review times. The conversation moves to BMS’ Cobenfy Phase 3 ARISE trial results and uniQure’s breakthrough therapy designation for its Huntington’s disease gene therapy. The group then revisits a discussion about biotech market updates and short selling. They also shared perspectives on Harvard University’s lawsuit against the Trump Administration, the broader issue of academic freedoms, and antisemitism on college campuses. The episode concludes with a discussion on the challenging microenvironments, CEO survival tips, and an overview of how investors are evaluating data. *This episode aired on April 25, 2025.
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Episode 138 - April 11, 2025
On this week’s episode, Chris Garabedian, Brad Loncar, Eric Schmidt, Paul Matteis, and Tess Cameron begin by recapping the markets, highlighting the rise in bond yields. The discussion then transitions to the efficiency of the FDA, noting its current overextension. Next, the group addresses an open letter from biotech executives and investors to Senator Bill Cassidy, highlighting the dismissal of key employees important to FDA review processes. Park Marks’ dismissal is also revisited, along with the impending threat of pharmaceutical tariffs. Wrapping up the discussion on the FDA, its initiative to replace animal testing is overviewed. The conversation shifts to “zombie” biotechs and ongoing private investment, as evidenced by recent Series A announcements. On the data front, Lexeo’s plans to initiate a registrational trial for its gene therapy for Friedreich ataxia, Rhythm’s Phase 3 data, and its stock price increase are discussed. The group also reviews the strategies early companies can adopt now that the IPO window has closed. The episode concludes with a review of notable updates from AAN 2025 and ADPD 2025. *This episode aired on April 11, 2025.
A weekly discussion of all things biotech – breaking news, data, deals, and FDA actions – with a community of biotech industry leaders and experts. Join the live streams hosted by @BiotechCH, @daphnezohar, @bradloncar and @biotech1 on Twitter Spaces every Friday at 12pm ET.
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