rf-fullcolor.png

 

February 19, 2026
by Jason Scott

Recon: Hims & Hers to buy Australia's Eucalyptus for up to $1.15B; BioNTech sues Moderna over COVID vaccine patents

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • 5 key people to watch at HHS after Trump’s shake-up (STAT)
  • NIH Director Bhattacharya to lead CDC after O’Neill’s exit (STAT)
  • FDA chief Marty Makary says ‘everything should be over the counter’ unless drug is unsafe or addictive (CNBC)
  • FDA will drop two-study requirement for new drug approvals, aiming to speed access (The Independent)
  • GDUFA IV: More ANDA Postmarket Commitments Coming? (Pink Sheet)
  • US FDA’s Push For Greater Transparency: What About Advisory Committees? (Pink Sheet)
  • Exclusive: US CDC cancels February vaccine adviser meeting, no new one set yet (Reuters) (STAT)
  • BioNTech sues Moderna for patent infringement over COVID shots (Reuters)
In Focus: International
  • As China’s drug industry races ahead, its GLP-1 race is accelerating too (STAT)
  • Zimbabwe rolls out new HIV prevention drug lenacapavir (Reuters)
  • UK Industry Fires Warning Shots Over Cost Burden, Support Levels And Over-Regulation In Market (MedTech Insight)
  • UK: Industry Needs To Work With Academia On Pre-Clinical ‘Translational Gap’ (Pink Sheet)
  • Ultra-Rare Disease Drug Loargys Wins English Funding Ahead Of US FDA Verdict (Pink Sheet)
Pharma & Biotech
  • I took part in a 2012 psilocybin trial. What I’m seeing now horrifies me (STAT)
  • Hims to buy Eucalyptus as it looks to expand globally (STAT)
  • Hims & Hers GLP-1 pill gambit backfires, accelerating crackdown on drug compounders (Reuters)
  • My biggest GLP-1 ethical problem: patients who don’t want to stop (STAT)
  • Led by former Trump official, Altesa raises $75M to advance respiratory med (Endpoints)
  • Why clinical AI startup Kintsugi shut down (Endpoints)
  • Charles River sees demand increase, says clients are 'back to work' as tariff uncertainties fade (Endpoints)
  • J&J pours $1B into new cell therapy site in Pennsylvania (Endpoints)
Medtech
  • Apple Watch’s hypertension feature may miss some cases, researchers find (MedTech Dive)
  • FDA issues early alert on Trividia glucometer issue linked to 114 injuries (MedTech Dive)
  • Medtronic nets FDA clearance for robotic spine system (MedTech Dive)
  • Federal judge strikes down FTC rule expanding premerger reporting requirements (MedTech Dive)
  • Cassidy Report Emphasizes Faster Access To Innovations (MedTech Insight)
  • Women’s Health Investment Poised For Rebound In 2026 (MedTech Insight)
Food & Nutrition
  • New FDA guidance for antibiotic use in food-producing animals prompts criticism over antibiotic resistance (STAT)
  • EU says cereulide exposure risk low after baby formula recalls (Reuters)
  • FDA’s Latest Nudge to Phase Out Petroleum-Derived Color Additives (FDA Law Blog)
Government, Regulatory & Legal
  • In a financial pinch, major health insurers are turning to AI for help (STAT)
  • Cassava Sciences says US DOJ has closed investigation into company (Reuters)
  • Senate health committee chair plots future FDA changes (Endpoints)
  • After Moderna Flu Vaccine, Is US FDA’s Accelerated Approval A Pathway Or A Pressure Valve? (Pink Sheet
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.