Recon: J&J to acquire Intra-Cellular Therapies for $14.6 billion; Commission publishes EU MDR initiatives for 2025
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
