Recon: Sanofi inks $1.7B deal with Dren Bio for autoimmune therapy; MHRA approves GSK’s twice-yearly asthma treatment
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Trump order blocking state AI laws could slow health AI adoption, leave patients vulnerable (STAT)
- AstraZeneca, Daiichi's breast cancer drug gets FDA nod as first-line treatment (Reuters)
- Medicare routes $16 billion to insurers to offset high drug costs (STAT)
- Gilead's experimental HIV treatment non-inferior to blockbuster drug in trial (Reuters)
- Moderna Takes on Unusual FDA Request: Do Its Vaccines Cause Long Covid? (Bloomberg)
- US FDA sends warning letters to Walmart, Target for selling recalled baby formula (Reuters)
- US FDA grants priority voucher to J&J's blood cancer treatment (Reuters)
- Europe’s pharma policy shakeup moves forward toward enactment (STAT)
- China has a cheap, quick and quiet way to test novel therapies. Western genetic medicine makers want in (Endpoints)
- UK approves GSK's twice-yearly asthma drug (Reuters)
- UK Doctors Plan Strike This Week After Rejecting Streeting Offer (Bloomberg)
- Sanofi returns to Dren Bio for another B cell depletion therapy at $100M upfront (Endpoints)
- Areteia Therapeutics, a $425M bet on asthma disorder, to wind down after terminating Phase 3 studies (Endpoints)
- Adaptive signs deal with Pfizer worth up to $890 million for rheumatoid arthritis research (Reuters)
- Kyverna to take autoimmune CAR-T to FDA after success in stiff person syndrome trial (Endpoints)
- Aviceda's geographic atrophy drug fails mid-stage study. Can it do better in Phase 3? (Endpoints)
- Palvella unwraps Phase 2 data for rapamycin gel in rare skin disease (Endpoints)
- InnoCare says Zenas-partnered drug succeeds in China study in form of lupus (Endpoints)
- Immunome's rare tumor drug passes Phase 3 test, could challenge Merck KGaA (Endpoints)
- Sanofi flags second delay to FDA decision on multiple sclerosis drug, shares fall (Reuters)
- Cencora to take majority control of cancer care network OneOncology for $5 billion (Reuters)
- Fosun Plans to Buy Maker of Controversial Alzheimer’s Drug (Bloomberg)
- OpenAI-Backed Chai Discovery Raises $130 Million for AI-Designed Molecules (Bloomberg)
- Argenx Drops After Discontinuing Thyroid Eye Disease Drug Trial (Bloomberg)
- Everything is changing in dementia diagnosis and treatment (STAT)
- Medical Supplier Medline Guides IPO to Upper Half of Price Range (Bloomberg)
- FDA needs more staff, authority to oversee device recalls, watchdog finds (MedTech Dive)
- AtriCure treats first patients with dual PFA/RF system (MedTech Dive)
- Mick Farrell named chair of AdvaMed board (MedTech Dive)
- All Change For Notified Bodies: Moving Towards A More Highly Regulated Future (MedTech Insight)
- As superbug fears grow, sales of antibiotics used in food-producing livestock rose dramatically last year (STAT)
- Explainer: What is lumpy skin disease for cattle and why are French farmers angry? (Reuters)
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