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10 June 2025
by Jason Scott

Recon: FDA approves Merck’s RSV antibody for infants; Gilead’s HIV combo studies placed on hold

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Vaccine stocks muted as Wall Street takes 'wait and watch' approach after Kennedy's shake-up (Reuters)
  • Kennedy's firing of independent CDC advisers undermines vaccine confidence, experts say (Reuters)
  • GOP senators zero in on Medicaid policy in Trump’s tax bill that has little impact on enrollment (STAT)
  • Merck’s RSV antibody treatment for infants is approved by FDA (STAT)
  • US FDA places clinical hold on Gilead trials testing HIV pill combination (Reuters)
In Focus: International                                                                                                       
  • ‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe (Pink Sheet)
  • Novo Nordisk starts new CagriSema weightloss drug trial (Reuters)
  • The Quiet Voices Questioning China’s AI Hype (Bloomberg)
  • Three Steps To Investor Heaven For Medtech Founders: Articulate, Explain, Clarify (MedTech Insight)
  • EU plan would limit Chinese device makers in Europe (MedTech Dive)
Pharma & Biotech
  • National Resilience, startup hoping to reinvent drug manufacturing, to ‘wind down’ many of its facilities (STAT)
  • Avidity, FDA reach agreement on accelerated filing of rare disease drug (STAT)
  • Hims & Hers says its weight-loss business can grow as US market changes (Reuters)
  • GoodRx goes toe-to-toe with Hims, Ro as it pushes into ED treatment (Endpoints)
  • Insmed's drug for rare lung disease meets main goal in mid-stage trial (Reuters)
  • Exclusive: Rebooting dead human brains, a biotech startup seeks to reinvent early drug testing work (Endpoints)
  • Exclusive: Scorpion spinout gets $177M for stealthy pipeline amid China competition (Endpoints)
  • Former a16z biotech investment leader Vijay Pande exits the VC firm (Endpoints)
  • Recursion to lay off 20% of staff, a month after slashing its pipeline (Endpoints)
  • Odyssey pulls back from IPO plans as public markets remain frozen (Endpoints)
Medtech
  • AI In Health Delivery: Patients Most Confident When HCPs Are In Charge (MedTech Insight)
  • Aneira Health Launches New Precision Medicine Platform Exclusively For Women (MedTech Insight)
  • Thermo Fisher Cuts Annual Profit Outlook Amid Estimated $400M Tariff Hit (MedTech Insight)
  • Elekta appoints Jakob Just-Bomholt as CEO (MedTech Dive)
Food & Nutrition
  • The Use of UV-C Light in Combination With Hydrogen Peroxide to Disinfect Packages in ESL and Aseptic Beverages (Food Safety)
  • FDA cuts imperil food safety, but not how you might think (Science News)
  • FDA warns food processors about Listeria, allergen and sanitation violations (Food Safety News)
Government, Regulatory & Legal
  • RFK Jr.’s chronic disease agency would eliminate or reduce funding for some prevention programs (STAT)
  • We have ‘post-vaccination syndrome.’ We are tired of being used to score anti-vax points (STAT)
  • Congressional report alleges organ procurement groups use loophole to boost ratings (STAT)
  • HBCUs can help create a 21st-century bioeconomy and the talent pipeline it requires (STAT)
  • US FTC Continues Effort To Eliminate Orange Book’s Improper Patent Listings (Pink Sheet)
  • HHS Secretary Favors Regenerative Medicine Over Traditional Pharma: Blessing And Curse? (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.
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