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April 22, 2024
by Jason Scott

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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.
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