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)
- 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)
- 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)
- 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)
- 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)
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