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August 1, 2024
by Michael Mezher

Recon: Sanofi to build new €1.3B insulin plant in Frankfurt; Novo launches Wegovy in Australia

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Lilly says weight loss drug cuts heart failure risk by 38% in trial (Reuters)
  • Lilly CEO says weight-loss drug shortage to end 'very soon', Bloomberg News reports (Reuters)
  • Biogen lifts profit forecast, signals progress in turnaround effort (Reuters)
  • Moderna cuts 2024 sales forecast, sees low EU vaccine revenue into 2026 (Reuters)
  • The health care records of 5 leading candidates to be Harris’ VP (STAT)
  • With Biden’s departure in sight, advocates seek to preserve gains of Cancer Moonshot (STAT)
  • 23andMe CEO proposes to take company private (MedtechDive)
  • It took more than two decades for MDMA to reach the FDA. In two months, its prospects cracked. What happens next? (Endpoints)
In Focus: International
  • Sanofi to invest 1.3 bln euros in new insulin plant in Frankfurt (Reuters)
  • Novo Nordisk launches weight-loss drug Wegovy in Australia (Reuters)
  • Indian drugmaker Sun Pharma posts Q1 profit beat on strong local sales (Reuters)
  • Behind the malaria vaccines: A 40-year quest against one of humanity’s biggest killers (STAT)
  • Otsuka buys startup Jnana, adding to uptick in private biotech M&A (BioPharmaDive)
Pharma & Biotech
  • Benefit of Eisai and Biogen's Alzheimer's drug increases over time, studies suggest (Reuters)
  • Merck raises outlook for electronics and healthcare, sees improved chip market demand (Reuters)
  • Pfizer mulls facility sale; GSK penalized in South Korea for administrative breach (Endpoints)
  • Jim Wilson, gene therapy pioneer, departs Penn to set up new companies (STAT)
  • Takeda's Entyvio holds onto IBD market share despite threat from AbbVie's Skyrizi (Fierce)
  • Teva factored IRA's next round of negotiations into its growth plans (Endpoints)
  • FibroGen to shrink US workforce by 75% following more late-stage fails (Endpoints)
  • FDA questions Zevra’s resubmitted data for rare disease drug ahead of adcomm (Endpoints)
  • FDA shoots down second Novartis petition seeking to halt Entresto generics (Endpoints)
  • Bayer lops off 70 more employees at New Jersey headquarters (Fierce)
  • Valneva pays LimmaTech $10M for clinical-stage Shigella vaccine (Fierce)
  • Sage changes main endpoint in Huntington's study months ahead of readout (Endpoints)
  • After norovirus vaccine's trial failure, HilleVax lays off 40% of staff (Endpoints)
  • EMA To Revamp Pre-Submission Dialog For Smoother Drug Reviews (Pink Sheet)
  • EMA Tackles Rising Cardiovascular Risks Of Cancer Treatments (Pink Sheet)
Medtech
  • Europe’s Medtech Market Is Going Strong, Medtech Europe Reports (MedtechInsight)
  • Becton Dickinson tops profit estimates on demand for drug-delivery devices (Reuters)
  • Teleflex raises 2024 profit forecast on medical device demand (Reuters)
  • Smith & Nephew jumps to one-year high as profit beats estimates (Reuters)
  • Labcorp beats Q2 profit and revenue estimates on demand for health tests (Reuters)
  • Labcorp expands Ultima pact to boost genomic diagnostics (MedtechDive)
  • FDA sends warning letter to defibrillator battery manufacturer (MedtechDive)
  • FDA, Health Canada team up to raise awareness of J&J’s Megadyne recall (MedtechDive)
  • CMR Surgical Kick Off Pediatric Clinical Trial With Surgical Robot Versius (MedtechInsight)
  • Stryker plans ‘very active’ M&A, ortho robot launches in 2H (MedtechDive)
Government, Regulatory & Legal
  • Rising rates of skin cancer: The cost of FDA’s inaction on novel sunscreen products (STAT)
  • Del. Judge Clears Lupin's Generic Kidney Disease Drug (Law360)
  • Judge rejects Novo Nordisk's IRA case as pricing negotiations conclude (Endpoints)
  • Could SCOTUS Chevron Reversal Reverse FDA’s Final Rule On LDTs? (MedtechInsight)
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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