Recon: J&J boosts cancer portfolio with $3.05B Halda acquisition; RFK Jr. reportedly discussed scaling back Makary’s role at FDA
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- RFK Jr. Discussed Curbing FDA Head’s Role After Complaints About Management Style (WSJ) (Reuters)
- FDA unveils new path to speed personalized therapies, inspired by Baby KJ (Endpoints)
- Novo Nordisk rolls out $349 Wegovy cash price ahead of plan (Reuters)
- US appeals court to weigh reviving cases over Tylenol and autism (Reuters)
- Johnson & Johnson acquires Halda Therapeutics for $3 billion, a big win for a buzzy new technology (STAT) (Reuters)
- FDA’s Plan To Boost Biosimilar Drugs Could Stall at the Patent Office (KFF)
- China’s WuXi AppTec, after evading threat of U.S. restrictions, comes out ahead (STAT)
- DKSH Said to Bid for Swiss Drug Distributor Swixx Biopharma (Bloomberg)
- Ethiopia Confirms First Outbreak of Marburg Virus After Testing (Bloomberg)
- Leaked Digital Omnibus Draft: Will EU’s Push For Simplification Help Medtech? (MedTech Insight)
- German Medtech Faces 2026 In Better Shape Vs Economic and Operational Pressures (MedTech Insight)
- New UK VPAG Extension Means Pharma Can Make Informed Decision For The First Time (Pink Sheet)
- UK MHRA Could ‘Evolve’ Its ‘Clunky’ Early Access To Medicines Scheme (Pink Sheet)
- Sanofi's type 1 diabetes drug recommended for EU approval (Reuters)
- Brain organoid pioneers fear inflated claims about biocomputing could backfire (STAT)
- Nuvalent sees success for its second genetically targeted lung cancer drug (STAT)
- Hims & Hers names ex-FDA official Deb Autor as first policy chief (Reuters)
- US FDA adds strongest warning to Sarepta's Elevidys after fatal liver injuries (Reuters)
- Sanofi CEO: How we’re measuring AI success (STAT)
- Novo Nordisk has stocked up for aggressive launch of Wegovy pill (Reuters)
- Activist Starboard sells Pfizer stake after pushing for changes (Reuters)
- Five takeaways after Merck's $9.2B Cidara deal: More M&A, 'diversified' growth, shifting production to the US (Endpoints)
- Jeffrey Bluestone hands Sonoma CEO post to Stephen Dilly (Endpoints)
- I spent two hours telling a chatbot about mental health problems. Its responses scared me (STAT)
- Resmed CEO Mick Farrell on new technologies, tariffs and AI (MedTech Dive)
- Zimmer wins FDA clearance for updated knee robot (MedTech Dive)
- ByHeart’s ‘bizarre’ response to infant botulism outbreak worries food safety experts (STAT)
- Congress appears unwilling to stop state ingredient bans in blow to food industry (Food Dive)
- Judge says he’ll approve opioid settlement with OxyContin maker Purdue and Sackler family (STAT)
- Medicare premiums to jump 10% heading into 2026 (STAT)
- Texas judge in Tylenol case won't block Kenvue's $398 million dividend payment (Reuters)
- Texas Measles Outbreak Prompted Surge in Early Vaccination (MedPage Today)
- Conflicting COVID Shot Advice Likely to Push Vaccine Uptake Even Lower, Experts Warn (MedPage Today)
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