rf-fullcolor.png

 

February 12, 2026
by Jason Scott

Recon: Prasad went against FDA staff to refuse to review Moderna’s flu vaccine; Sanofi ousts Paul Hudson as CEO

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Trump administration revives effort to launch pilot initiative reworking drug discount program (STAT)
  • Prasad overruled FDA staff to reject Moderna’s flu vaccine application (STAT)
  • The old Vinay Prasad never left. He just changed jobs (STAT)
  • How employers feel about the state of healthcare (and GLP-1s) (Endpoints)
  • CDC moves to cut $600M in grants to Democrat-led states (MedTech Dive)
  • Dozens of Democrats call for removal of newly appointed OB-GYNs from vaccine advisory panel (The Hill)
In Focus: International
  • European VCs band together to improve the landscape for biotech startups (STAT)
  • Even Europeans don't see a future in Euro biopharma anymore: Endpoints Signal (Endpoints)
  • In Mexico, at least 28 have died from measles outbreak that started 2025 (Reuters)
  • Bringing Net Zero Onto The Radar For UK Healthtech Innovators (MedTech Insight)
Pharma & Biotech
  • Talkiatry raises $210 million, eyeing opportunity to use AI for engaging with patients (STAT)
  • Big Health raises funding as investors see glimmer of hope for digital therapeutics (STAT)
  • BridgeBio drug for genetic cause of dwarfism succeeds in key study (STAT)
  • Paul Hudson out as Sanofi CEO (STAT)
  • Terray says its AI model beats a popular open-source model at predicting how molecules bind with proteins (Endpoints)
  • In a first, one CAR-T therapy is going up directly against another in trial (Endpoints)
  • Utah startup Leash Bio warns AI models could 'cheat' in biology. It bets its own 'dinky' model shows the way forward (Endpoints)
  • CSL's bleak earnings report helps explain why it made CEO switch (Fierce Pharma)
  • J&J’s Tremfya roars into 2026 with massive TV ad spend, trailed by AbbVie’s Rinvoq and Skyrizi (Fierce Pharma)
Medtech
  • FDA Approves First Home-Use Pancreatic Cancer Treatment Device (MedTech Insight)
  • US import block on vapes could cut illegal sales by a third, BAT says (Reuters)
  • Neurent raises $74M to commercialize treatment for nasal condition (MedTech Dive)
  • AdvaMed names Melissa Torres as new leader for technology and regulatory affairs (MedTech Dive)
  • Zimmer plans US salesforce reorganization (MedTech Dive)
  • Edwards focuses on earlier TAVR adoption (MedTech Dive)
  • Solace Health Raises $130M In Series C Round Bringing It To $1Bn Valuation (MedTech Insight)
Food & Nutrition
  • FDA to reassess safety of snack food preservative BHA (Food Dive)
  • Fresh produce has a messaging problem (Food Dive)
Government, Regulatory & Legal
  • RFK Jr's vaccine agenda faces Boston judge who has handed Trump setbacks (Reuters)
  • Drug injection fades as smoking grows more common, marking sea change in U.S. fentanyl epidemic (STAT)
  • Students, faculty mystified as NSF turns back applications for prestigious fellowship program (STAT)
  • Four states sue Trump administration over cuts to public health funding (Reuters)
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.