Recon: J&J to acquire Intra-Cellular Therapies for $14.6 billion; Commission publishes EU MDR initiatives for 2025

• Eli Lilly acquires cancer program from Scorpion Therapeutics in $2.5B deal (STAT)
• J&J to buy Intra-Cellular Therapies for $14.6B, picking up mental health drug (STAT)
• In debate over obesity medications, FDA shifts toward importance of drugs in subtle ways (STAT)
• Cigna, Centene, Walgreens drop out of J.P. Morgan conference (STAT)
• Purdue's Sacklers offer to increase contribution in new opioid settlement, WSJ reports (Reuters)
• Lilly sues two medical spas over copycat weight-loss drugs (Reuters)
• Moderna Shares Plunge After Company Cuts Sales Outlook (Bloomberg)

• GSK to buy cancer-focused IDRx in $1 billion deal (STAT)
• EU Consultation Deadline Looms For Pharmacovigilance Rules Update (Pink Sheet)
• Game-Changing EU-Level HTA Regs Must Allow For Lessons To Be Learned (Pink Sheet)
• Commission Publishes List Of Immediate MDR Initiatives To Be Adopted In 2025 (MedTech Insight)
• Mason Capital complains about Grifols' transparency to Spanish regulator (Reuters)
• Lilly Sees New Weight-Loss Pill Approval in Early 2026, CEO Says (Bloomberg)

• Biogen CEO confirms he’s shopping for biotechs: ‘We will be doing deals’ (STAT)
• Healthcare dealmakers eye M&A resurgence in second Trump term (Reuters)
• Intellia cuts 27% of staff, in the latest wave of gene-editing layoffs (STAT)
• Spurred by AI’s possibilities, Eli Lilly and Andreessen Horowitz partner on $500M venture fund (STAT)
• Normunity nabs $75M Series B to advance T cell engager and launch first trial (Endpoints)
• Aragen gets $100M from private equity firm to expand manufacturing footprint (Endpoints)
• AstraZeneca, CRISPR tools supplier ink gene editing enzyme licensing deal (Endpoints)
• Gilead taps into STAT6 space via $250M deal with Leo Pharma (Endpoints)
• Post-Hoc: Big Pharma is losing the AI talent war (Endpoints)
• Y-mAbs splits from commercial chief, tasks new hire with growing cancer drug sales (Fierce Pharma)
• Matt McNally rejoins Publicis, leaving Omnicom for CEO role at agency’s health unit (Fierce Pharma)
• New Mountain Nears Deal to Acquire Access Healthcare (Bloomberg)
• Sage Therapeutics Jumps on Biogen’s $469 Million Offer (Bloomberg)

• Exclusive: Bucking gene editing downturn, Tune raises $175M to bring epigenetic editing to clinic (Endpoints)
• Exclusive: Moderna's former top scientist has a new startup using AI to improve mRNA therapies (Endpoints)
• More hospitals need to assess predictive models for accuracy, bias: Health Affairs (MedTech Dive)
• Eko Health names Justin Spencer as CFO (MedTech Dive)
• Fire1 raises $120M to trial heart failure management system (MedTech Dive)
• Nvidia Partners With Illumina and Mayo Clinic in Health Push (Bloomberg)

• ‘My life’s purpose’: A neuroscientist wants to rewire mental illness treatment and remake the field he loves (STAT)
• DOJ seeks interviews with former UnitedHealth Group doctors (STAT)
• Biden’s top antitrust official calls for breaking up powerful health care companies (STAT)
• Science and Politics May Collide As US FDA Offers More Precise Definitions Of Sex And Gender (Pink Sheet)
• FDA Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway (FDA Law Blog)
• FDA Publishes Final Guidance For Communicating Off-Label Uses. First Amendment Questions Remain (MedTech Insight)