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October 15, 2024
by Jason Scott

Recon: Eli Lilly’s Omvoh bests J&J’s Stelara in late-stage study for Crohn’s; Innovation in the EU medtech market

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
  • J&J trims pipeline, including two mid-stage neuroscience studies (Endpoints)
  • Lilly’s Omvoh Beats J&J’s Stelara in Head-to-Head Phase III Crohn’s Disease Trial (BioSpace)
  • J&J’s recent medtech buys help to prop up devices unit (MedTech Dive)
  • Maryland biotech gets green light for stem cell-derived therapy for diabetes, aiming to compete with Vertex (Endpoints)
  • GlaxoSmithKline sues Moderna for US patent infringement over COVID vaccines (Reuters)
  • UnitedHealth forecasts 2025 profit below Street estimates, shares fall (Reuters)
  • PBM Reform Legislation: PhRMA ‘Laser Focused’ On Passage This Year (Pink Sheet)
  • Baxter bolsters IV supplies with imports to address US shortages in wake of Hurricane Helene (Fierce Pharma)
In Focus: International                                                                                                                                
  • Forbion raises €2.1B for two new biotech funds after series of company exits (Endpoints)
  • Britain to study use of Lilly's weight loss drug to get people back to work (Reuters)
  • Bayer submits EU marketing application for menopause relief drug (Reuters)
  • Medtechs Dig Deep For UK System Positives But Take Issue With MHRA Fees Hike (MedTech Insight)
  • NoBoCap: Navigating The EU Regulatory Landscape For MedTech Innovation (MedTech Insight)
  • French Bill Calls For €1bn In Drug Price Cuts, Simplifies Payback (Pink Sheet)
  • EU Decision Time For Hemophilia Drug Concizumab & 10 Other Products (Pink Sheet)
Pharma & Biotech
  • Broad Institute announces layoffs, largely in IT, software engineering (STAT)
  • Pfizer partners with molecular glue startup Triana in $49M upfront deal (Endpoints)
  • First patient who received engineered B cell therapy sees early promise for MPS I (Endpoints)
  • Cycle makes another offer for Vanda; Ocean Biomedical, Molecure ink new deal (Endpoints)
  • MeiraGTx's stock rises on small Parkinson's gene therapy dataset (Endpoints)
  • Tolerance Bio emerges from stealth with $17.2M to advance therapies developed from the thymus (Endpoints)
  • Exclusive: Biotech tools company raises $75M for protein manufacturing tech (Endpoints)
Medtech
  • US FDA clears CMR Surgical's robotic device to assist gall bladder removal (Reuters)
  • Hologic to buy Gynesonics for $350M to acquire fibroid system (MedTech Dive)
  • Medtronic to evaluate Affera in ventricular tachycardia (MedTech Dive)
  • J&J, Abbott and Intuitive kick off latest medtech earnings season (MedTech Dive)
Government, Regulatory & Legal
  • 11 experts on why gains in cardiovascular disease are stalling and what we can do about it (STAT)
  • Otsuka calculates dementia caregivers would earn 6 figures if paid for work (Fierce Pharma)
  • 5 Accelerated Approvals Gone Wrong (BioSpace)
 
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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