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• Euro Roundup: MHRA commission makes recommendations on AI regulatory framework in the UK
  A commission set up by the Medicines and Healthcare products Regulatory Agency (MHRA) has shared 44 recommendations about the future regulatory framework for AI in the UK.
  raps · 4d ago
• Stakeholders urge FDA to define data, treatment standards as psychedelic drugs near market
  Safety and access were top of mind at Monday’s public hearing exploring the regulation of psychedelic therapies. "The medicine opens the door,” NeuroAlchemy co-founder Michaela Vogt said during the…
  biospace · 5d ago
• Novartis shareholder calls for board overhaul following costly deal setbacks: Reuters
  Novartis’ recent dual clinical setbacks have prompted questions from a major shareholder about the board’s oversight of dealmaking.
  fiercebiotech · 11d ago
• UK regulator halts sales of Tavneos; UniQure seeks approval for Huntington's gene therapy
  Plus, news about Regeneron, Novocure, Jazz's Ziihera, BioMarin, Ascendis, AstraZeneca, Hutchmed and TScan Therapeutics. Another road bump for Tavneos: The Medicines and Healthcare products Regulato…
  endpoints · 18d ago
• Euro Roundup: MHRA updates guidance on submitting safety reports for UK products
  The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its pharmacovigilance procedures guidance with new advice about periodic safety update reports (PSURs).
  raps · 25d ago
• STAT+: Pharmalittle: We’re reading about a GSK shingles shot, U.S. employers dropping GLP-1 coverage, and more
  About 14% of employers in the U.S. have already or plan to drop coverage of GLP-1 drugs in 2027, as companies see ​rising health care costs
  stat · 25d ago
• Enveda’s exercise-simulating obesity tablet clears early clinical test
  Touting an “exceptional” gastrointestinal safety profile for its oral obesity drug candidate in a study of healthy volunteers, Enveda plans to test the asset in people stopping GLP-1 treatment.
  biospace · 1mo ago
• Slate uses Fulcrum to vault onto Nasdaq with $245M financing for migraine trials
  Slate Medicines is hurtling toward a Nasdaq listing, securing a reverse merger with Fulcrum Therapeutics six months after exiting stealth and ahead of the publication of clinical data on its lead c…
  fiercebiotech · 1mo ago
• Opinion: How to disrupt the health misinformation business model
  One way to fight medical misinformation: make it easier for people to understand when they are being manipulated, write Paul Martin Jensen and Avi Tuschman.
  stat · 1mo ago
• Silence cashes in on ‘differentiated’ data; UK reaffirms support for childhood vaccines
  Some analysts believe Silence’s polycythemia vera drug could be superior to a closely watched Takeda medicine. Elsewhere, the FDA spurned a radiopharmaceutical and AbCellera shares climbed to level…
  biopharma_dive · 1mo ago