Recon: Eisai, Biogen nab FDA win for once-a-month Leqembi maintenance dose; Sage rejects $469M Biogen buyout
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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