Recon: WuXi to sell Irish facility to Merck; Lilly seeks to join suit against compounders

• 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)