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September 18, 2025
by Jason Scott

Recon: Roche to buy MASH biotech 89bio for $2.4B; Kennedy’s ACIP weighs changes to childhood vaccines

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Federal vaccine adviser says former CDC officials can’t be trusted unless they agree to ‘public debate’ (STAT)
  • Key takeaways on CDC hearing: Vaccine moves, experts sidelined, GOP attacks (The Hill)
  • Kennedy's hand-picked CDC panel weighs changes to children's vaccines (Reuters)
  • Despite fear of retaliation, hundreds of federal workers urge Congress to protect medicine and science (STAT)
  • HHS abruptly cancels CDC meeting with RFK Jr., anti-vaccine activist as scrutiny mounts (STAT)
  • Kennedy is rewriting US vaccine policy — fast and on his terms (Reuters)
  • New US global health plan prioritizes drugs, recipients' self-reliance (Reuters)
  • US Shutdown Risks Rise as Democrats Dig In on Health-Care Fixes (Bloomberg)
In Focus: International
  • WHO says 31 of 38 Ebola cases in Congo have resulted in deaths (STAT)
  • Alcohol, tobacco and food giants block health reforms, says WHO (Reuters)
  • Logistics real estate company promises £3.9B in UK life sciences investment (Endpoints)
  • GE Healthcare Said to Weigh Selling Stake in China Business (Bloomberg)
  • J&J launches IVL device in Europe; Medtronic looks at pacing for more patients (MedTech Dive)
  • Have Your Say On EU Digital Regulation Overkill (MedTech Insight)
Pharma & Biotech
  • Roche to enter FGF21 space with $2.4B buyout of MASH biotech 89bio (Endpoints)
  • Sangamo’s Fabry therapy partner search looks futile (STAT)
  • Wegovy-maker Novo Nordisk starts 'fight back' as investors return (Reuters)
  • Novo Jumps Most in Month as Ozempic Beats Older Lilly Drug (Bloomberg)
  • Replimune's stock sinks on rocky path forward for cancer drug's accelerated approval (Endpoints)
  • Nektar’s stock rallies on eczema data; Novo to lay off 263 workers in NJ (Endpoints)
  • Pfizer, Arvinas sell rights to lead PROTAC one month after filing for FDA review (Endpoints)
  • After trial win, Lilly's Mounjaro primed for expansion in kids 10-17 with type 2 diabetes (Fierce Pharma)
Medtech
  • Fresh data on hospital AI use & Califf dishes on tech (STAT)
  • House committee advances Medicare coverage bill for breakthrough devices (MedTech Dive)
  • Pair Of Safety Alerts In Line With Broader FDA Enforcement Crackdown (MedTech Insight)
Food & Nutrition
  • RFK Jr.’s Assault on Ultra-Processed Foods Puts Companies on Edge (Bloomberg)
  • JM Smucker to raise coffee prices again in the face of tariffs (Food Dive)
Government, Regulatory & Legal  
  • I’m a former CDC director. I’m deeply concerned about the future of vaccines in the U.S. (STAT)
  • NIH outlines new system for awarding research grants to foreign scientists (STAT)
  • Here’s who will be hit with higher premiums if ACA enhanced subsidies expire (STAT)
  • The coming fragmentation of vaccination social order (STAT)
  • FDA’s New Cosmetic Adverse Event Dashboard Presents Challenges and Opportunities (FDA Law Blog)
  • Obamacare Subsidy Extension Would Cost $350 Billion, CBO Finds (Bloomberg)
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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