Recon: BMS inks $380M CAR-T manufacturing deal with Cellares; Supreme Court tosses out Vanda’s sleep disorder drug patent case
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- UnitedHealth ghosts Congress on Change cyberattack — for now (STAT)
- An FDA pathway can accelerate innovation for Duchenne muscular dystrophy (STAT)
- Bristol Myers, Cellares sign global CAR-T deal as biopharma companies look to diversify manufacturing partners (Endpoints) (Fierce Pharma)
- Biden administration issues privacy rule protecting abortion (Reuters)
- Drug distributor Cardinal Health to lose OptumRx contracts (Reuters)
- Eli Lilly to acquire manufacturing facility from Nexus Pharma (Reuters)
- U.S. Supreme Court rejects Vanda Pharmaceuticals case over sleep-drug patents (Reuters)
- GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows (Pink Sheet)
- Ahead of Alnylam's key heart disease readout, experts say Pfizer rival would be hard to displace (Fierce Pharma)
- Regulatory tracker: J&J, Legend's Carvykti wins second-line myeloma nod in Europe (Fierce Pharma)
- Moment Of Truth For Seven EU Filings; Cytokinetics To Make Its Case For Heart Failure Drug (Pink Sheet)
- EU Countries Offered Funding To Contribute to African Regulatory Strengthening (Pink Sheet)
- First Of Its Kind: UK Hospital To Apply For ADA-SCID Gene Therapy Approval (Pink Sheet)
- No Korea-Originated New Drugs Approved Domestically In 2023 (Pink Sheet)
- EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications (Pink Sheet)
- Contaminated cough syrup in Africa no longer available – WHO (Reuters)
- Novo Nordisk’s growth plan (STAT)
- Biosplice searches for a path forward after osteoarthritis drug fails late-stage study (Endpoints)
- Pfizer to shutter research operations at Colorado site acquired in Array deal (Endpoints)
- Ipsen, Skyhawk ink deal worth up to $1.8B; Hepion to wind down NASH trial (Endpoints)
- Boehringer Ingelheim inks chronic liver disease research pact with Ochre Bio (Endpoints)
- Rubedo pulls in $40M Series A to advance atopic dermatitis candidate targeting aging cells (Endpoints)
- Eisai, BioArctic to develop new drug for Alzheimer’s that can cross blood-brain barrier (Endpoints)
- The next frontier in data privacy? Your brain (STAT)
- Vape maker Chill Brands suspends CEO (Reuters)
- Exactech recalls shoulder devices after initially declining to act (MedTech Dive)
- Cancer test maker Dermtech to cut 100 jobs, explore strategic options (MedTech Dive)
- FDA approves Lumicell’s breast cancer imaging tool (MedTech Dive)
- Intuitive’s rollout of new da Vinci 5 robot steals Q1 spotlight (MedTech Dive)
- Spinoffs, sales and tuck-ins top medtech deal priorities: Moody’s (MedTech Dive)
- How a scientific slip-up caused a pregnant woman to get an untested treatment for preterm birth (STAT)
- USDA releases H5N1 bird flu genetic data eagerly awaited by scientists (STAT)
- “Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application . . . And a Corrected NDA Approval Letter is No Saving Grace (FDA Law Blog)
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