Recon: Tenaya forges $1.13B pact with Alnylam; FDA approves J&J’s blood cancer drug under CNPV program
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- A month in, TrumpRx falls short of president’s grand promises (STAT)
- RFK Jr. has wide discretion to choose evidence to support vaccine decisions, DOJ argues (STAT)
- The extremism of the FDA’s Marks and Prasad has come with costs (STAT)
- FDA puts PepGen’s Phase 2 muscle disease trial on partial hold (Endpoints)
- FDA's top operating official Butler to retire, deputy to take over in April (Endpoints)
- Exclusive: US postpones third consecutive meeting of preventive health panel (Reuters)
- Tariff refunds: Court provides first step with liquidation order (MedTech Dive)
- US to hike global tariff to 15% ‘sometime this week,’ Bessent says (MedTech Dive)
- FDA Guidance Sheds (Some) New Light on 3-Year New Clinical Investigation Exclusivity (FDA Law Blog)
- Gilead and South Africa are negotiating a license for local production of new HIV drug (STAT)
- Multimillion-dollar gene therapies weren’t supposed to face competition. China has other plans (Endpoints)
- Insmed Holds Off Ex-US Brinsupri Launches Amid MFN Uncertainty (Pink Sheet)
- India Proposes Single Ethics Review Model To Boost Multicenter Trials (Pink Sheet)
- As UK, India Regulators Collaborate On Cell And Gene Therapies, Harmonization Would Help (Pink Sheet)
- Rethink Of UK’s Relationship With EU ‘Makes Sense For Patients And Medtech Innovators’ (MedTech Insight)
- ‘We Can’t Wait Years’ For MDR/IVDR Change: Industry Urges EU Co-Legislators To Move At Pace (Medtech Insight)
- Eli Lilly launches program for employers to subsidize cost of obesity drug outside insurance (STAT)
- Standardized 12-Digit NDC Transition Not As Long As Industry Hoped (Pink Sheet)
- AI could revolutionize antibiotics — but the market is standing in the way (STAT)
- Obesity drugs may silence the ‘drug noise’ behind all addiction (STAT)
- Merck KGaA drops two cancer trials on assets from SpringWorks deal (Endpoints)
- Tenaya wins support from Alnylam in cardio disease pact (Endpoints)
- Health AI dispatch from SF (Endpoints)
- CVS taps Google Cloud to roll out AI-powered health platform (Reuters)
- CAR-T Guidelines Signal China’s Next Phase Of Cell Therapy Regulatory System Building (Pink Sheet)
- Cognito raises $105 million for Alzheimer’s treatment device (STAT)
- Inside CMR Surgical’s big pivot before US robot launch (MedTech Dive)
- Medtech industry calls for FDA staffing transparency in MDUFA talks (MedTech Dive)
- Vicarious Surgical receives NYSE delisting notice (MedTech Dive)
- Stryker execs discuss Mako RPS launch at AAOS (MedTech Dive)
- ‘The Place to Be’: How Real-World Evidence (And NEST) Are Reshaping Device Submissions (MedTech Insight)
- More than 50 medical schools will expand nutrition education in agreement with RFK Jr. (STAT)
- Grocery prices are set to rise in 2026 (Food Dive)
- Kennedy's new US autism panel to examine potential causes (Reuters)
- A new mystery emerges about Epstein’s involvement in Harvard genetics study (STAT)
- How hospitals have shifted from experimenting with AI to justifying its cost (Endpoints)
- Yale’s Craig Crews builds model to guide biotech startups out of academia’s ‘valley of death’ (Endpoints)
- Amazon launches AI-enabled platform to automate healthcare administrative tasks (Reuters)
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