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March 5, 2026
by Jason Scott

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Food & Nutrition
  • 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)
Government, Regulatory & Legal
  • 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
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.
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