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September 30, 2025
by Jason Scott

Recon: Trump says Pfizer will cut US prices; Sanofi targeted in EU vaccine antitrust investigation

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

In Focus: US
  • Trump to roll out plan aimed at lowering prescription drug prices (STAT)
  • Trump announces Pfizer price cuts as White House presses drugmakers (Reuters)
  • Dems go hard on ACA tax credits in shutdown negotiations (STAT)
  • LifeMD to offer Novo's Ozempic at $499/month to eligible US cash-paying customers (Reuters)
  • Top FDA drug regulator’s unusual criticism of a therapy gets Wall Street wagging (STAT)
In Focus: International                                                                                                       
  • Sanofi says under investigation by European Commission over vaccines (Reuters)
  • Commission carries out unannounced antitrust inspections in the vaccines sector (European Commission)
  • AstraZeneca's US listing may pull other firms from London in its wake (Reuters)
  • European Commission says it is carrying out raids at premises of company active in vaccines sector (Reuters)
  • UK will not impose sales tax on private healthcare, minister says (Reuters)
  • Under new CEO, Novo ends heart failure partnership with Japanese biotech (Endpoints)
  • Rapid Flurry Of Late September EU Regulatory Developments (MedTech Insight)
  • Indian Medtech Firms See Limited Impact From H-1B Visa Fee Hike, But R&D Collaboration Faces Risks (MedTech Insight)
Pharma & Biotech
  • Indivior to stop marketing Opvee, controversial overdose-reversal medication (STAT)
  • As investor for AHA, ‘Venture Valkyrie’ argues ‘good medicine is good business’ (STAT)
  • Lilly’s head scientist discusses its GLP-1 pill, Alzheimer’s strategy, and finding promising ideas and startups (STAT)
  • Push to create functional human eggs in the lab stumbles, pioneering fertility researcher reports (STAT)
  • Crystalys Therapeutics launches with $205 million funding round for trials of gout drug (Reuters)
  • Star gets $125M Series D as it begins Phase 3 in bleeding disorders (Endpoints)
  • Metsera’s new obesity data mean Pfizer has side effect and efficacy questions to answer (Endpoints)
  • Merck makes the case for PAH drug Winrevair in patients with earlier disease (Endpoints)
  • Barinthus’ reverse merger with private biotech; Sutro to lay off 33% of employees (Endpoints)
  • AnaptysBio plans to split its pipeline from its royalty assets into two publicly traded companies (Endpoints)
Medtech
  • FDA expands early alert program to cover all medical devices (MedTech Dive)
  • Medtech firms splitting into ‘haves’ and ‘have-nots’: EY (MedTech Dive)
  • EssilorLuxottica wins FDA OK for myopia-slowing eyeglass lenses (MedTech Dive)
  • Countdown To Shutdown: Some CDRH Operations Would Continue In Funding Freeze (MedTech Insight)
  • Medical Device Weaponization: Section 232 Investigation (FDA Law Blog)
Food & Nutrition
  • Right direction or wrong track: Is RFK Jr.’s food policy really making America healthier? (Food Dive)
  • How Kellanova uses AI to predict creative performance and drive KPIs (Food Dive)
Government, Regulatory & Legal  
  • A former CDC director’s guide to seeing and stopping threats to America’s health (STAT)
  • Walmart takes on wellness (Endpoints)
  • After months of investigation on drug tariffs, Trump seals new levies with a social media post (Endpoints)
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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