rf-fullcolor.png

 

November 17, 2025
by Jason Scott

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Food & Nutrition
  • 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)
Government, Regulatory & Legal  
  • 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.