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September 2, 2025
by Jason Scott

Recon: Novartis licenses Arrowhead's neuromuscular drug for up to $2B; Paul Offit removed from FDA’s VRBPAC

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

In Focus: US
  • RFK Jr. critic Paul Offit dismissed from FDA's vaccine advisory committee (Endpoints) (Pink Sheet)
  • The key health care policies at stake in Congress’ government funding fight (STAT)
  • Trump says CDC is ‘being ripped apart’ over Covid products, calls for drugmakers to prove their benefits (STAT)
  • Exclusive: Kennedy's autism data project draws more than 100 research proposals (Reuters)
  • Arrowhead, Novartis in up to $2 billion deal for neuromuscular therapy license (Reuters)
  • Sanofi's Wayrilz snags FDA endorsement in ITP (Fierce Phama)
  • Eisai scores FDA nod for subcutaneous Leqembi maintenance dose (Fierce Pharma)
In Focus: International
  • Chinese companies turn to generics as shipments behind US weight-loss craze fade (Reuters)
  • CapVest snaps up German generics maker Stada (Fierce Pharma)
  • Which Countries Have Adopted International Regulatory Alignment Documents? (MedTech Insight)
  • Sweden’s Sectra Expands Global Digital Pathology And AI Footprint (MedTech Insight)
  • Swissmedic Slashes Months Off Review Time For Certain Drug Filings (Pink Sheet)
  • How England’s Cancer Vaccine Launch Pad Helped Scancell Speed Up Trial Patient Recruitment (Pink Sheet)
Pharma & Biotech
  • Ionis drug lowers triglycerides, reduces pancreas damage in late-stage studies (STAT)
  • United Therapeutics shares hit record high after late-stage win for lung disease drug (Reuters)
  • Cytokinetics' drug more effective for heart disease symptoms than standard-of-care (Reuters)
  • Make statins available without a prescription (STAT)
  • Biotech veterans John Maraganore, Clive Meanwell launch new heart disease startup with lofty goals (STAT)
  • Merck's cholesterol drug gets a boost with another late-stage trial success (Reuters)
  • Zymeworks halts development of cancer drug after trial setback (Reuters)
  • Nvidia-backed Charm Therapeutics gets $80M to take AI-designed cancer drug to clinic (Endpoints)
  • Upstream Bio's Phase 2 win could set it up as a potential Dupixent, Tezspire competitor (Endpoints)
  • Exclusive: Neon Health raises $6M for AI to help patients access specialty drugs (Endpoints)
  • Merck, Bayer's Verquvo posts perplexing trial fail (Fierce Pharma)
  • Novo Backed by Key Danish Investor as Drugmaker Seeks Revival (Bloomberg)
Medtech
  • As reports of ‘AI psychosis’ spread, clinicians scramble to understand how chatbots can spark delusions (STAT)
  • AI devices with no clinical validation tied to more recalls, study finds (MedTech Dive)
  • European Commission Review of the MDR and IVDR – Where Are We Right Now? (MedTech Insight)
  • Outdated SME Thresholds Need EU Review, Say German Medtechs (MedTech Insight)
Food & Nutrition
  • Women and Older Adults are Driving Sales of Creatine Higher (Bloomberg)
  • Kraft Heinz to Separate Into Two Publicly Traded Companies (Bloomberg)
Government, Regulatory & Legal  
  • U.S. science and universities are becoming political hostages in the Orbánization of knowledge (STAT)
  • Trump administration restored funding for major diabetes study. The pause still set researchers back (STAT)
  • Appellate court rules Trump’s global tariffs illegal, but delays action (MedTech Dive)
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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