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May 27, 2025
by Jason Scott

Recon: CDC pulls COVID vaccine recommendation for healthy children, pregnant women; Eli Lilly to purchase SiteOne in deal valued up to $1B

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • US drops COVID vaccine recommendations for healthy children, pregnant women (Reuters) (CNN)
  • At a major genome editing summit, spotlight turns to the value of human life (STAT)
  • Colorado Drug Pricing Board Hits Back at Amgen Legal Challenge (Bloomberg Law)
  • US FDA approves use of Sanofi's meningococcal vaccine in infants (Reuters)
  • Eli Lilly to buy privately held SiteOne in deal worth up to $1 billion (Reuters)
In Focus: International                                                                                                       
  • I’m a dentist from India. The fluoride debate in the U.S. horrifies me (STAT)
  • Majority of medical equipment supplies at 'stock zero' in Gaza, WHO says (Reuters)
  • Sanofi exploring vaccine production in Vietnam with local partner (Reuters)
  • Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs (MedTech Insight)
  • German Bionic Launches ‘Strongest Exoskeleton To Date’ (MedTech Insight)
  • EU To Track Decentralized Clinical Trials In CTIS To Support Innovation (Pink Sheet)
  • Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A (Pink Sheet)
Pharma & Biotech
  • Participant in Rocket Pharmaceuticals gene therapy study dies (STAT)
  • Longevity seekers misunderstand a fundamental truth about biology (STAT)
  • Roche extends trials of promising antibiotic against resistant superbug (The Financial Times)
  • Blackstone's GRIN inks epilepsy licensing deal with Angelini, closes $140M Series D (Endpoints)
  • Gilgamesh’s short-acting psychedelic drug shows rapid effect in Phase 2 depression study (Endpoints)
  • ITM reveals up to $262M debt financing; Caris Life Sciences to go public (Endpoints)
  • Biogen taps City Therapeutics in RNAi deal worth up to $1B (Endpoints)
  • Prothena’s amyloidosis drug flops again, spending and staff cuts are on the way (Endpoints)
  • Syndeio debuts with $90M+ to bring together synapse repair drugs (Endpoints)
  • Investors pump $130M into protein degrader startup GlycoEra (Endpoints)
  • Exclusive: Toronto biotech ProteinQure nears the clinic with peptide platform as it raises $11M Series A (Endpoints)
Medtech
  • The AI threat to public health no one is thinking about: a fake bioterrorist attack (STAT)
  • Brooklyn Health raises $6.5M to standardize mental health assessment (Endpoints)
  • BD recalls esophagogastric tubes linked to 2 serious injuries, 1 death (MedTech Dive)
  • Medtronic To Spin Out Diabetes Unit As New Products Solidify Turn-Around Story (MedTech Insight)
  • Medtronic Eyes Up to $350M Tariff Hit in FY26, Leans On Cost Controls And Pricing Strategy (MedTech Insight)
Food & Nutrition
  • Swedish Food Agency Publishes 2019-2023 Analysis of Foodborne Illnesses (Food Safety)
Government, Regulatory & Legal
  • To address the pharmacy crisis, doctors should dispense some drugs (STAT)
  • A Harvard scientist built a database of 2,100 NIH grant terminations. Then his own funding was cut (STAT)
  • STAT Plus:In its flagship journal, the CDC keeps publishing papers after firing scientists who made the research possible (STAT)
  • What Baby KJ means for the CRISPR gene editing industry (STAT
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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