Episode 163 - November 14, 2025

On this week’s episode, John Maraganore, Yaron Werber, Ami Fadia, and special guests STAT’s Allison DeAngelis and Endpoints News’ Drew Armstrong kick things off with an overview of the latest FDA staffing changes, including long-time oncology chief Richard Pazdur’s appointment as the new CDER director, a move the co-hosts view as positive for the industry and a sign of potential stability. Next, the group breaks down the FDA’s new ‘Plausible Mechanism Pathway’, designed to accelerate certain personalized therapies to market when traditional trials aren’t feasible. Allison then shares insights from her reporting on the exclusive MAHA Summit held earlier this week -- an invite-only gathering of top HHS officials and leading biotech executives. In data news, the co-hosts discuss Alkermes’ Phase 2 narcolepsy trial, Cogent’s Phase 3 gastrointestinal stromal tumor results, and CRISPR’s cholesterol data. As one bidding war ends, another begins as Alkermes’ move to acquire Avadel faces competition from Lundbeck, who offered a $2.25 billion, rivaling Alkermes’ initial $2.1 billion offer. Drew Armstrong also overviewed his reporting on the Novo Nordisk-Pfizer bidding war, noting both companies’ obesity setbacks and their search for new directions. Deal-making conversations continues with Merck’s $9.2 billion acquisition of Cidara Therapeutics, and Day One Therapeutics’ $285 million acquisition of Mersana Therapeutics. The episode concludes with a discussion on the passing of genetic pioneer James Watson and Eli Lilly CEO David Ricks’ appearance on The Cheeky Pint podcast. *This episode aired on November 14, 2025.