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)
- 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)
- 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)
- 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)
- Women and Older Adults are Driving Sales of Creatine Higher (Bloomberg)
- Kraft Heinz to Separate Into Two Publicly Traded Companies (Bloomberg)
- 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)
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