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August 18, 2025
by Jason Scott

Recon: Novo Nordisk to sell discounted GLP-1s at the pharmacies; FDA’s absence from international standards meetings imperils U.S. leadership

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

In Focus: US
  • Novo Nordisk’s obesity drug Wegovy cleared to treat MASH (STAT)
  • Wall Street sees new obesity pills as priced near Wegovy and Zepbound (Reuters)
  • Draft of major MAHA report calls for more education, less regulation — and offers few policies (STAT)
  • RFK Jr. Is Sabotaging President Trump’s Health Legacy (Bloomberg)
  • Bayer Reaches Settlement Over Seattle-Area School PCB Cases (Bloomberg)
  • Sometimes Less is More: FDA Issues White Paper on Selective Safety Data Collection (FDA Law Blog)
In Focus: International                                                                                                                                
  • The FDA’s absence from international standards meetings threatens U.S. leadership (STAT)
  • Shionogi Weighs Making Antibiotics in US Amid Rising Tariffs (Bloomberg)
  • UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech (MedTech Insight)
  • Japan To Cut Leqembi Price By 15% Following Cost Effectiveness Review (Pink Sheet)
Pharma & Biotech
  • Health care CEOs harvest billions even as industry lags broader stock market (STAT)
  • Stealth BioTherapeutics discloses FDA rejection letter in effort to rally support for rare disease drug (STAT)
  • Novo Nordisk offers Ozempic at $499 per month to eligible US cash-paying customers (Reuters)
  • What other health conditions are weight-loss drugs being tested for? (Reuters)
  • US FDA approves Tonix Pharma's drug to manage pain related to chronic condition (Reuters)
  • Genentech ends up to $2B cell therapy collab with Adaptive (Endpoints)
  • Gene therapy startup Kriya Therapeutics gets $313M (Endpoints)
  • Stealth resubmits ultra-rare disease drug to FDA; Boehringer's retinal deal (Endpoints)
  • Updated: Reunion’s psychedelic approach in postpartum depression clears Phase 2 trial (Endpoints)
  • Eli Lilly Taps High-Grade Market With Rare 40-Year Paper (Bloomberg)
  • How the Moms and Dads of Patients Won Sarepta’s Drug a Reprieve (Bloomberg)
Medtech
  • Exclusive: Athletics-New gene tests system in disarray ahead of world championships (Reuters)
  • Heart devices pace medtech’s summer funding flows (MedTech Dive)
  • Philips will spend $150M to expand manufacturing for AI-enabled tech (MedTech Dive)
  • Nyxoah Launches FDA-Cleared Genio System For OSA As Rival Inspire Files Patent Suit (MedTech Insight)
  • Inaccurate Carbon Dioxide Readings Prompt Class I Recall Of Draeger Ventilation Filters (MedTech Insight)
Food & Nutrition
  • Culinary medicine pioneer David Eisenberg: ‘If you know how to make one stir-fry, you can make 1,000’ (STAT)
  • Draft 'MAHA' commission report avoids pesticide crackdown feared by farm groups (Reuters)
  • Artificial Dyes Are Disappearing Inside the Welch’s Fruit Snacks Factory (Bloomberg)
  • FMI says it’s concerned about tariffs’ impacts on grocery prices (Food Dive)
  • WK Kellogg signs legal agreement to remove artificial dyes from cereals (Food Dive)
Government, Regulatory & Legal  
  • With U.S. funding for science at risk, a longtime advocate sees ‘light at the end of the tunnel’ (STAT)
  • Former CDC Director William Foege: How public health can fight back in a time of dangerous nonsense (STAT)
  • End the unchecked growth of publishing fees and the overreliance on unpaid peer review (STAT)
  • Conflicts of interest among federal vaccine advisors were ‘historically low’ through 2024 (Endpoints)
  • Texas Ends Measles Outbreak With No New Cases Since July (Bloomberg)
 
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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