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July 29, 2025
by Jason Scott

Recon: Sarepta resumes shipments of Elevidys for ambulatory patients; Merck to cut costs by $3B

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

In Focus: US
  • NIH is shrinking the number of research projects it funds due to a new Trump policy (STAT)
  • FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt (STAT) (Reuters)
  • FDA approves PTC’s rare genetic disease drug (Endpoints)
  • Post-Hoc: Is this what a political FDA looks like? (Endpoints)
  • Medical group urges Kennedy not to fire US care task force (Reuters)
  • US Senate Democrats to investigate Kennedy's firing of vaccine expert panel (Reuters)
  • FDA recommends 7-OH compound found in vapes be controlled (Reuters)
  • A Las Vegas Festival Promised Ways to Cheat Death. Two Attendees Left Fighting for Their Lives. (ProPublica)
In Focus: International                                                                                                       
  • Novo Lifer Takes Job of Reviving Europe’s Weight-Loss Superstar (Bloomberg)
  • Wegovy maker Novo's profit warning triggers $70 billion share rout (Reuters )
  • EU 15% Tariff Deal Still Leaves Questions For Pharma On Possible Grace Period, Generic Exemption (Pink Sheet)
  • New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls (Pink Sheet)
  • Expedited Reviews For China-Originated Drugs Shift Back Home (Pink Sheet)
  • Recordati's core profit rises, but sees bigger FX hit (Reuters)
Pharma & Biotech
  • Novo Nordisk names new CEO as it cuts growth outlook (STAT)
  • Fulcrum study results suggest a pill can treat sickle cell disease (STAT)
  • Merck announces $3B in cost cuts (Endpoints) (Bloomberg)
  • AstraZeneca seeks US drug price cuts amid expansion plans, strong demand (Reuters)
  • Lilly's cancer drug more effective than AbbVie's in head-to-head study (Reuters)
  • Novo Is to Lilly What LVMH Is to Hermes, Fund Manager Reckons (Bloomberg)
  • Publicis Health picks up p-value medical comms group (Fierce Pharma)
Medtech
  • With Ambience’s new mega-round, AI scribes have announced nearly $1 billion in funding this year (STAT)
  • Health tech is bucking healthcare investing trends (Endpoints)
  • Philips lowers expected tariff hit to 150M-200M euros (MedTech Dive)
  • Quest, Labcorp downplay ‘Big Beautiful Bill’ impact (MedTech Dive)
  • NIH-Backed Scanner Opens New Frontier For Understanding The Human Brain (MedTech Insight)
  • Edwards Lifesciences Lowers Tariff Impact Forecast, Keeps Gross Margin Guidance Intact (MedTech Insight)
  • FDA’s Latest Lists for Digital Health Technologies (FDA Law Blog)
Food & Nutrition
  • Snickers maker Mars to invest $2B in US manufacturing through 2026 (Food Dive)
  • Voluntary sustainable packaging goals are on the way out, Gartner says (Food Dive)
Government, Regulatory & Legal  
  • Researchers sequence complex parts of human genome, expanding the future of precision medicine (STAT)
  • UnitedHealth CEO says some parts of business need ‘fundamental reorientation’ (STAT)
  • How the FDA can score quick wins on transparency (STAT)
  • U.S. must develop plan to protect clinical trials as national security asset (STAT)
  • A cut to Medicare that could affect millions is buried in Trump’s tax law (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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