Recon: Eisai, Biogen nab FDA win for once-a-month Leqembi maintenance dose; Sage rejects $469M Biogen buyout

• Sara Brenner named acting FDA commissioner (MedTech Dive)
• U.S. health agencies see some chaos — but an FDA approval gets through (STAT)
• Sage rejects Biogen's $469 million takeover offer, says offer undervalues company (Reuters)
• Trump’s restrictions spark chaos across health and science agencies (STAT)
• ‘This is censorship’: Trump freeze on communications forces medical journal to pull HHS authors’ article (STAT)
• Veteran researcher who was critical of U.S. response to Covid named acting NIH head (STAT)
• Biogen CEO tells Mass. governor he’s concerned about ‘a lot more policy risk’ in D.C. (STAT)
• Trump 2.0 blog: RFK confirmation hearings this week; Federal return-to-office is coming (Endpoints)
• Eisai and Biogen win approval for once-monthly Leqembi maintenance dosing (Endpoints)
• Novo Nordisk to cap insulin prices in Minnesota settlement; joins Lilly, Sanofi (Reuters)
• US FDA drops web pages on improving clinical trial diversity (Reuters)
• Trump says he may consider rejoining World Health Organization

• Germany’s ITM, a stalwart in radiopharmaceuticals, gets ready to take its own shots (STAT)
• UK biotech launches with T cell therapy technology to treat solid tumors (Endpoints)
• UK detects human case of bird flu, says wider risk remains low (Reuters)
• How Pharma Can Prepare For Incoming EU Health Data Sharing Rules (Pink Sheet)
• Why Notified Bodies Should Answer To A Centralized Regulatory Authority (MedTech Insight)

• Akero drug reverses liver scarring in study of severe MASH patients (STAT)
• Veru says its drug preserved lean mass in patients taking Wegovy (STAT)
• Exclusive: Leerink builds healthcare M&A team, poaching dealmakers from rivals (Endpoints)
• Confirmatory Trials: US FDA Expectations Become Clearer Amid FDORA Flexibilities (Pink Sheet)
• Cell therapy startup Aurion files for IPO, despite ongoing legal battle with investor Alcon (Endpoints)
• Cell therapy startup Aurion files for IPO, despite ongoing legal battle with investor Alcon (Endpoints)
• Metsera outlines $250M IPO plans as obesity biotech competition rises (Endpoints)
• Allakos restructures after Phase 1 failure; AB2 inks deal with Nippon Shinyaku (Endpoints)
• Maze looks to lead IPO queue with $113M Nasdaq debut (Endpoints)

• Q&A: Why this health AI startup is shutting down (STAT)
• Beta Bionics targets $114M IPO raise to fund insulin pump development (MedTech Dive)
• Medtronic links closed-loop pain device to improvements after 12 months (MedTech Dive)
• Boston Scientific Pulse Field Ablation System Meets Clinical Endpoints For Persistent AF (MedTech Insight)

• Who is protecting Americans from Marburg right now? (STAT)
• Pfizer to pay $60 million to settle claims that Biohaven paid kickbacks to doctors (STAT)
• CMS withdraws appeal of UnitedHealth Medicare Advantage star ratings case (STAT)
• Trump ends Fauci’s security detail and says he’d feel no responsibility if harm befell him (STAT)
• Trump freeze on NIH grant reviews alarms scientists, with long-term impact uncertain (STAT)
• US reports first outbreak of H5N9 bird flu in poultry (Reuters)
• Vanda Loses US Trade Secrets Battle Over Fanapt And Hetlioz Generics (Pink Sheet)