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January 26, 2026
by Jason Scott

Recon: Drugmakers pivot to AI to speed trials, submissions; MHRA impounded 20M illegal drugs last year

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Drugmakers turn to AI to speed trials, regulatory submissions (Reuters)
  • CDC pauses, then unpauses billions in public health infrastructure grants to states (STAT)
  • CDC vaccine advisors contradict each other on committee goals (Endpoints)
  • FDA’s new ‘plausible mechanism pathway’ for personalized gene editing raises concerns (STAT)
  • Shared decision-making on vaccines is not the enemy (STAT)
In Focus: International
  • UK medicines agency seized 20M illegal drugs last year, including GLP-1s (Endpoints)
  • EU kicks off one-year pilot to expedite multinational trials (Endpoints)
  • Astrazeneca CEO Soriot to join Starmer delegation to China, source says (Reuters)
  • Ethiopia declares end of Marburg outbreak that killed nine (Reuters)
Pharma & Biotech
  • Endometriosis often takes years to diagnose. Startups want to change that (STAT)
  • Sarepta touts three-year Duchenne gene therapy data after patient deaths rattled field (Endpoints)
  • Genmab halts enrollment for cancer drug from ProfoundBio buyout (Endpoints)
  • Novo's Wegovy pill gets off to solid start, while analysts remain cautious (Endpoints)
  • F2G CEO outlines biotech's FDA resubmission plans, funding and expansion (Endpoints)
  • Sanofi's Phase 3 eczema data cloud hopes for potential immunology blockbuster (Endpoints)
Medtech
  • STAT Plus:Former executives of device maker Zynex Medical indicted for fraud (STAT)
  • Intuitive’s cardiac initiative includes valve repair, LAA closure (MedTech Dive)
  • Medtronic wins CE mark for single-shot pulsed field ablation catheter (MedTech Dive)
  • Congress eyes tackling healthcare consolidation (MedTech Dive)
  • Intuitive pushes into cardiac robotic surgery, ASCs (MedTech Dive)
  • Be Wary Of Chatbots Dispensing Health Advice, Warns ECRI (MedTech Insight)
  • EIT Innovation Program Delivers A KIC-Start For EU Medtech Ventures (MedTech Insight)
Food & Nutrition
  • Powdered whole milk could be a culprit in the ByHeart botulism outbreak, tests show (STAT)
  • Explainer: What is cereulide, the toxin suspected in recalled baby formula? (Reuters)
  • Infant formula recall hits Danone, Nestle shares (Reuters)
  • Think RFK Jr.’s Vitamin Crusade Is All MAGA? Think Again (Bloomberg)
Government, Regulatory & Legal
  • Dozens of hospitals demand better security for patient record sharing in letter to officials (STAT)
  • Public health giant William Foege, who helped eradicate smallpox, has died at 89 (STAT)
  • Our podcast ‘Why Should I Trust You?’ connects MAHA and public health. Here’s what we’ve learned (STAT)
  • Meta, TikTok, YouTube to stand trial on youth addiction claims (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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