Recon: Senate hearing set for FDA nominee; Novo partners with Anthropic for AI drug development
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- US Senate panel sets hearing for Trump's FDA pick (Reuters)
- The FDA’s rebuilding effort is running into a new challenge (STAT)
- FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A (FDA)
- CDC delay holds up children's COVID vaccine orders, WSJ reports (Reuters) (WSJ)
- Advil-maker Haleon boosts US sales by targeting consumers on weight-loss drugs (Reuters)
- Kennedy names new members to Preventive Services Task Force, after months of vacancies (STAT)
- US regulators examine testosterone therapy for women as experts debate evidence, safety (Reuters)
- Drug companies have cooperated with lawmaker’s probe of China trial sites (Endpoints)
- FDA-ordered studies of many drugs, devices on the market are not done (Washington Post)
In Focus: International
- Novo partners with Anthropic to speed up drug development with Claude (Reuters)
- Novo, Orbis sign up to $1.4 billion deal to develop oral drugs (Reuters)
- AstraZeneca-Daiichi breast cancer drug cleared for NHS use in England (Reuters) (STAT)
- UK government committees call for probe into US pharma deal (Endpoints)
- Novartis halts ALS drug development after mid-stage trial failure (Reuters)
- Inside MHRA’s Plans To Build A Global ‘Blueprint’ For AI Regulation (MedtechInsight)
- Zealand’s Glepaglutide Faces Crucial EMA Hearing After US Setback (Pink Sheet)
- Zerion partner files first EU application for Dispersome‑enabled product (PharmaTimes)
- ByteDance completes $290 million fundraising for AI drug unit after its spin-off, sources say (Reuters)
Pharma & Biotech
- Drugmakers prepare for next phase of space pharmaceuticals as ISS retirement nears (Reuters)
- Sling Therapeutics raises $123 million to advance thyroid eye disease drug (Reuters)
- Longeveron explores strategic options after therapy fails mid-stage trial for infant heart condition (Reuters)
- Roche turns to Dualitas to find new bispecific approaches for immunology (Endpoints)
- Roche eyes label expansion for Lunsumio after confirmatory lymphoma trial win (Endpoints)
- A Sellas immunotherapy study, long delayed, will end in failure (Reuters)
- Bavarian Nordic names Tarja Stenvall as new CEO (Endpoints)
- Japan approves prefilled syringe for GSK’s shingles vaccine (PharmaTimes)
- Use of untested 'Wolverine' peptide backed by US Health Secretary Kennedy on the rise, study finds (Reuters)
- OTC Industry Makes First PDUFA Appearance After Months of Behind-the-Scenes Negotiations (Pink Sheet)
- Gene-Silencing Therapies Face Different Bar Under US FDA Plausible Mechanism Framework (Pink Sheet)
- The Next Gene-Editing Technology May Also Be the Oldest (NYTimes)
Medtech
- RAPS Convergence: CDRH Stability Faces New Test As Center Begins To Rebuild Depleted Staff (MedtechInsight)
- FDA Rejects Harrison.ai Request To Exempt Some Radiology AI From 510(k) Requirements (MedtechInsight)
- J&J sells Laminar LAA closure assets it bought 3 years ago (MedtechDive)
- FDA clears vessel-sealing device for Medtronic’s Hugo robot (MedtechDive)
- Medtronic Hit With Second Class I Recall For Bravo CF Capsule Delivery Device As Injuries Reach 184 (MedtechInsight)
Government & Legal
- Cassidy grills surgeon general pick on vaccines (Politico)
- CMS expands ACCESS pilot to boost use of digital health tech (MedtechDive)
- Scientists challenge US NIH grant screening as unconstitutional (Reuters)
- Pennsylvania asks for CDC measles help amid Kennedy dispute (Reuters)
- Republican senator faults Trump vaccine policy for US measles deaths as panel weighs health nominees (Reuters)
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.