Recon: Bayer wins FDA approval for stroke prevention drug; Third Rock enters $2B partnership with AI-focused Chinese biotech
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Bayer wins FDA approval for stroke prevention drug with blockbuster potential (Endpoints) (FDA)
- FDA defines risk-based potency approach to cell and gene therapy (Pink Sheet)
- How early efforts to build autonomous clinical AI tools are approaching regulation (Endpoints)
- Virtuoso robot wins FDA nod for bladder tumor removal (Medtech Dive)
- Compass Pathways completes FDA filing for COMP360 psilocybin in treatment-resistant depression (The Pharma Letter)
- Delivering answers and hope for rare disease families (FDA)
In Focus: International
- Russia to localize production of certain drugs and vaccines in Africa (The Pharma Letter)
- Dutch antitrust regulators probe Biogen over test for its MS drug (STAT)
- Scientific questions remain as Aumseqa heads for new EU verdict just weeks after revocation (Pink Sheet)
- Korea streamlines review of digital convergence combos (Pink Sheet)
- Pharma is a ‘mixed bag’ when providing drug access to low- and middle-income countries, analysis finds (STAT)
Pharma & Biotech
- Third Rock enters $2B partnership with AI-focused Chinese biotech (Endpoints)
- Lilly's weight-loss pill improves sleep apnea in late-stage trial (Reuters) (Endpoints)
- Boehringer, Zealand's obesity drug did not raise heart risks in trial, data shows (Reuters) (BioSpace)
- J&J eyes US nod for Caplyta in bipolar mania after second trial win (Reuters) (Fierce Pharma)
- Veradermics wraps phase 3 program in men with 'better-than-expected' hair growth at 1 year (Fierce Pharma)
- Altimmune gears up for FDA meeting on pivotal Phase 3 trial in alcohol use disorder (BioSpace)
- Mirum's liver infection drug lowers virus levels in second late-stage study (Reuters) (Fierce Biotech)
- AstraZeneca bolsters vaccine pipeline with US-biotech Omniose acquisition (Reuters)
- Beam preps FDA run for industry-first base-edited therapy after pivotal sickle cell success (BioSpace)
- Abeona Therapeutics acquires ABO-801 from Ellodi (The Pharma Letter)
- Hims & Hers to offer unapproved peptides after US eases curbs (Reuters)
Medtech
- FDA seeks input on telesurgery, autonomous robotics (MedTech Dive) (Medtech Insight)
- CMS to expand coverage for infusion pumps, tighten requirements for DME suppliers (Medtech Insight)
- MDR 2.0: Recertifications remain a sticking point in negotiations (Medtech Insight)
Food & Nutrition
- FDA moves to revoke permission for some chemicals used in food dyes (Food Safety News)
- CDC declares end to outbreak traced to sprouts (Food Safety News)
- US GAO raises concerns about ‘little transparency’ around USDA reorganization (Food Safety Magazine)
Government & Legal
- States get another $10B for rural health as far bigger Medicaid cuts loom (Politico)
- US government removes WuXi AppTec from Chinese military list (Endpoints)
- Trump’s plan to lower drug prices in US is leading to fewer new drugs in Europe (Wall Street Journal)
- TwinStrand secures another USPTO win in $245M Guardant Health patent dispute (The Pharma Letter)
- FDA enforcement win raises interesting issues (Drug & Device Law)
- Trump’s drug pricing deals force tough choices on launches (Endpoints)
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.
