Recon: AstraZeneca to buy Fusion in targeted radiation deal valued at $2B; Seelos ALS treatment fails in mid-stage trial
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- More than 60% of US abortions in 2023 were done by pill, study shows (Reuters)
- US CDC urges measles vaccinations amid rising cases (Reuters)
- CDER, CBER Post FY 2023 Employee Gains, But Behind User Fee Hiring Goals (Pink Sheet)
- Biden expands women's health research, adds $200 million for sexual, reproductive issues (Reuters)
- The Dog That Didn’t Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews (Pink Sheet)
- Regeneron advances antitrust lawsuit against Novartis with appeals court's backing (Fierce Pharma)
- US FDA’s Anti-Misinformation Campaigns Look Safer After Supreme Court Oral Arguments (Pink Sheet)
- She stood between a dangerous drug and a generation of American babies (WTOP)
- EU lawmakers vote to extend exclusivity period for new medicines, softening Commission proposal (Reuters)
- 'Critical' to catch up on measles vaccinations to stem outbreaks, says WHO (Reuters)
- All Eyes On Pricing Model As EU Crunch Time Nears For First Ophthalmic Bevacizumab (Pink Sheet)
- Pakistan Explains Updated Risk-Based Criteria For GCP Inspections (Pink Sheet)
- EMA Presses On With Keenly-Awaited Guidance On How To Use Patient Experience Data (Pink Sheet)
- EU Pharma Reform Passes Major Hurdle, With Big Changes To Data Protection Proposals (Pink Sheet)
- Industry To Scrutinize Proposals On Updating Statutory Pricing Agreement (Pink Sheet)
- In small study, baby aspirin cuts fat buildup in liver disease patients (STAT)
- Wegovy and Zepbound get primetime treatment (STAT)
- Seelos Therapeutics' ALS treatment fails mid-stage study (Reuters)
- As targeted radiation field heats up, AstraZeneca to acquire Fusion Pharmaceuticals in $2 billion deal (STAT)
- Madrigal's $600M offering; PureTech to return $100M to shareholders (Endpoints)
- Highly-awaited PhIII study of Gates-backed tuberculosis vaccine underway (Endpoints)
- Morgan Health, JP Morgan’s healthcare venture, is looking to cut pharma costs next (Endpoints)
- Mid-stage neuroscience startup Engrail raises $157M (Endpoints)
- Crinetics reports second PhIII win for acromegaly drug, eyes 2025 launch (Endpoints)
- With positive PhIII data in hot flashes, Bayer is a step closer to challenging Astellas’ Veozah (Endpoints)
- Bayer to seek approval for menopausal relief drug after third trial win (Reuters)
- ‘An AI foundry’: Nvidia’s Jensen Huang pitches biotech on easy AI, with focus on software going beyond chips (Endpoints)
- Titan Medical to merge with imaging firm Conavi, ending strategic review (MedTech Dive)
- J&J Medtech, Nvidia partner to bring AI to the operating room (MedTech Dive)
- Intuitive details launch plan for new da Vinci 5 robot (MedTech Dive)
- Feeling the Heat (or Cold) – New Draft Guidance Addresses Requirements for Devices that Produce Thermal Effects (FDA Law Blog)
- Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development (MedTech Insight)
- UnitedHealth appears to be upping loan offers to providers, after Change cyberattack (STAT)
- Supreme Court questions restricting government efforts to limit Covid-19 misinformation (STAT)
- Novo Nordisk Foundation backs effort to build supercomputer with Nvidia (Endpoints)
- UnitedHealth says advanced over $2 bln in payments to providers (Reuters)
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