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May 13, 2025
by Jason Scott

Recon: FDA looks to remove ingestible fluoride products from the market; ITeos and GSK halt developing lung cancer therapy

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

In Focus: US
  • US FDA aims to remove fluoride supplements for children from market (Reuters) (FDA)
  • Our biggest burning questions on Trump’s order to bring down drug prices (STAT)
  • US senator calls for stronger ethics commitments from Trump deputy health secretary pick (Reuters)
  • Bayer: U.S. Supreme Court could decide in June whether it will hear glyphosate case (Reuters)
  • US Medicare lays out timeline for third round of drug price negotiations (Reuters)
  • Why Trump’s Drug Price Order Didn’t Rattle the Industry (Bloomberg)
  • Measles cases in Texas rise by eight to 717, state health department says (Reuters)
In Focus: International  
  • India's GlaxoSmithKline Pharma reports profit rise on strong demand (Reuters)
  • India's Cipla beats quarterly profit, banks on new drug launches for growth (Reuters)
  • Industry On Making England’s HTA Innovation Lab A Success (Pink Sheet)
  • UK Medtech Regulators Must Ensure Certainty So Businesses Can Plan Their Futures (MedTech Insight)
  • Swiss Outlook Cut at UBS With Warning on Trump’s Pharma Push (Bloomberg)
Pharma & Biotech
  • Investment firm RA Capital lays off incubator staff amid industry instability, push into China (STAT)
  • To understand why investors rejoiced at Trump’s attack on drug firms, think like a pharma CEO (STAT)
  • Hinge Health targets $2.6 billion valuation as IPO markets signal comeback (Reuters)
  • ITeos, GSK discontinue lung cancer therapy development (Reuters)
  • Updated: To spin off or not to spin off? Galapagos backpedals on separation plans, CEO Paul Stoffels exits early (Endpoints)
  • Arcturus to prioritize mRNA therapeutics in bid to boost rare disease programs (Endpoints)
Medtech
  • OpenAI leaps into health care with AI benchmark to evaluate models (STAT)
  • Elizabeth Holmes rises again — or at least her partner does (STAT)
  • Roche plans $550M expansion of Indianapolis site to manufacture CGMs (MedTech Dive)
  • ‘Pathologists Are Hungry For AI-Enabled Digital Pathology’ (MedTech Insight)
  • Physio App Maker Hinge Health, Backers Seek $437 Million IPO (Bloomberg)
Food & Nutrition
  • Why new wellness-branded energy drinks have health experts worried (STAT)
  • Danone brings Oikos into the $7 billion protein shake market (Food Dive)
  • Judge Orders Most Agencies to Pause Mass Layoffs for at Least Two Weeks (Food Safety)
  • Post Holdings sees tariffs slowing ‘active M&A pipeline’ (Food Business News)
Government, Regulatory & Legal
  • Andrew Witty steps down as UnitedHealth CEO (MedTech Dive) (STAT)
  • Opinion: Why Casey Means could be the right pick for surgeon general (STAT)
  • ‘What do we do with uncertainty?’ A former CDC director’s advice to new physicians and scientists (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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