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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.
Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.
Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.