Recon: WuXi to sell Irish facility to Merck; Lilly seeks to join suit against compounders
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA’s new guidance on AI in drug development centers the risk introduced by the technology (STAT)
- Eli Lilly seeks to join lawsuit on compounded drugs (STAT)
- Trump’s FDA transition team takes shape with former Hahn adviser, courts top Capitol Hill aide (STAT)
- FDA posts early alert about safety risk of Medline’s fluid delivery sets (MedTech Dive)
- Final Rule for ACNU Arrives in Time for End of Year but Not Much New to Celebrate (FDA Law Blog)
- Oculis’ eye drug clears Phase 2 in France as US development beckons (Endpoints)
- European macrocycle startup Orbis raises €90M (Endpoints)
- Australia Unveils Final Product Recall Reforms Ahead Of March Implementation (Pink Sheet)
- EU CHMP Opinions And MAA Updates (Pink Sheet)
- German Election Year: Medtech Industry Lays Out Ambulatory And Disease Management Demands (MedTech Insight)
- 45 Days Of MDCG Meetings In 2025: Where The EU’s Medtech Priorities Lie (MedTech Insight)
- China's WuXi Biologics to sell Irish vaccine facility to Merck as US curbs loom (Reuters)
- The biotech scorecard for the first quarter: 16 stock-moving events to watch (STAT)
- Exclusive: AI biotech Iambic snags CFO who helped steer Recursion-Exscientia deal (Endpoints)
- ‘Ozempic’s biggest night’: GLP-1s back in Hollywood spotlight at Lilly-backed 2025 Golden Globes (Fierce Pharma)
- Amylyx names chief commercial officer as GLP-1 receptor antagonist launch plans start ramping up (Fierce Pharma)
- CRO Veeda unveils 'modern and dynamic' rebrand to mirror expansion into CDMO services (Fierce Pharma)
- Point/Counterpoint: Combined Adcomm Briefing Document Not A Collaboration, US FDA Says (Pink Sheet)
- Study sparks call for funding reforms to protect patient groups from pharma influence (Fierce Pharma)
- FDA seeks to boost blood oxygen monitor accuracy across skin tones (Reuters)
- HHS proposes HIPAA update to boost healthcare cybersecurity (MedTech Dive)
- FDA closes 2024 with string of early alerts on device safety risks (MedTech Dive)
- FDA-commissioned review finds no safety concerns linked to tampons (MedTech Dive)
- Olympus begins CEO search after Kaufmann resignation (MedTech Dive)
- Hospitals now know how some health AI tools were developed. Will that change anything? (STAT)
- What Covid tried to teach us — and why it will matter in the next pandemic (STAT)
- The surgeon general is right: America has a drinking problem (STAT)
- Alcohol cancer risk warning may face tough road with Trump (Reuters)
- Why Medicaid cuts could be a ‘crisis’ for people with disabilities (STAT)
- Not a Good Look’: Premiums Could Jump If Trump’s CMS Drops Part D Demo (Pink Sheet)
- How sedation policies can limit access to abortion care (STAT)
- Florida car dealer joins insulin pricing fight against Eli Lilly, Sanofi (Endpoints)
- US to award $306 mln for bird flu monitoring and preparedness (Reuters)
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