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)
- 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)
- 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)
- 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)
- 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)
- 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)
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