Recon: FDA will review generic GLP-1; India floats faster licensing for some devices
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA set to review Sandoz's generic GLP-1s (Reuters)
- Look out, Amgen. Here comes Viridian with FDA nod for TED med Lumvoa (Fierce Pharma)
- FDA rejects Sobi’s gout drug over manufacturing issues, sparing Amgen blockbuster (Fierce Pharma)
In Focus: International
- FDA slaps Dr. Reddy's Hyderabad biologics plant with seven observations in new Form 483 (Fierce Pharma)
- The U.S.-China biotech crackdown may hurt the scientists America needs the most (STAT)
- Swiss pharma at risk of US trade investigation, industry body says (Reuters)
- EU regulator backs revoking Amgen's right to sell rare-disease drug (Reuters)
- Getting The EU MDR ‘Mostly Right’ Is A Juggling Act – The German Industry View (MedTech Insight)
Pharma & Biotech
- Investor Clive Meanwell on designing biotechs for population health, and AI’s role as a catalyst (STAT)
- AI scientist company Edison Scientific tapped by team behind Metsera to create new biotechs (STAT)
- Moderna co-founder Kenneth Chien on the future of mRNA — and Moderna (STAT)
- Zymeworks to acquire troubled biotech Theravance in $929M deal (Endpoints)
- Evommune's lead drug fails in chronic hives, stock sinks (Endpoints)
- Exclusive: Akeso pushes back on ASCO questioning of lung cancer drug (Endpoints)
- BioCryst ends internal discovery programs, will close Alabama research facility (Endpoints)
- Ipsen to buy blood cancer company Kartos Therapeutics for $450M upfront (Endpoints)
Medtech
- J&J starts pivotal trials of Shockwave IVL device in carotid arteries (MedTech Dive)
- Agilent finalizes Biocare Medical takeover (MedTech Dive)
- India Proposes Faster Medical Device Manufacturing License Timelines (MedTech Insight)
- Roche takes aim at Illumina's dominance with new gene sequencing machine (Reuters)
Food & Nutrition
- The Baby Formula Probe Produced a Pile of Evidence. Then the DOJ Dropped the Case. (The Wall Street Journal)
- Trump Issues Order to Reduce Pesticides in Food as Kennedy Allies Fume (The New York Times)
Government, Regulatory & Legal
- Facing a brutal run, battered vaccine makers still see cause for hope (STAT)
- Sword Health contracted to provide AI-supported physical therapy for an entire country (STAT)
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.
