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August 21, 2025
by Jason Scott

Recon: CVS won’t add Gilead’s HIV PREP jab to coverage lists; J&J to make $2B investment in US drug manufacturing

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Trump may push hard for lower drug prices using a tool created by Democrats (STAT)
  • US FDA approves Ionis' drug for rare genetic disorder (Reuters)
  • FDA agrees to speed review for an ultra-rare disease drug (STAT)
  • Exclusive: CVS holds off adding Gilead’s new HIV prevention shot to drug coverage lists (Reuters)
  • J&J to invest $2 billion to boost US manufacturing as drug tariffs loom (Reuters)
  • Politicizing Scientific Research Comes With a Hefty Price (Bloomberg)
  • HHS, CMS form advisory committee to improve patient care, call for nominations (Reuters)
  • FDA’s new expert panels are rife with financial conflicts and fringe views (LA Times)
In Focus: International                                                                                                       
  • Japan's Takeda weighs India for global trials to speed up drug launches (Reuters)
  • Trump’s ‘most favored nation’ policy will apply to EU generics (Endpoints)
  • Japan’s Daiichi Sankyo Shares Drop After Discounted Block Trades (Bloomberg)
  • Novo Obesity Shot Sees Interest Soar in UK as Rival Lifts Prices (Bloomberg)
  • US, EU agree to terms of framework trade pact (MedTech Dive)
Pharma & Biotech
  • Sarepta extends $700M debt to 2030, adds private placement amid Elevidys uncertainty (Fierce Pharma)
  • As Sarepta Therapeutics fights for Duchenne therapy, a group of patients gets left behind (STAT)
  • FDA ‘uncertainty’ forces Krystal Biotech to shutter cancer drug trial (STAT)
  • Serena Williams to promote weight-loss drugs with telehealth firm Ro (Reuters)
  • Riding high on Wegovy, Novo doubled its workforce. Now layoffs loom (Reuters)
  • Gilead unit to acquire cell therapy developer Interius for $350 million (Reuters)
  • Prader-Willi syndrome is not a zero-sum game. There's room for many winners (Endpoints)
  • Nicox eyes FDA submission as ocular hypertension drug passes Phase 3 (Endpoints)
  • Dynavax says its shingles shot was 'comparable' to Shingrix in early readout (Endpoints)
  • Rezolute hires ex-Ultragenyx exec for rare disease launch (Fierce Pharma)
  • Swoop, iSpot team up to tackle TV ad transparency for pharma (Fierce Pharma)
Medtech
  • FDA approves first-ever glucose monitoring system for weight loss from Signos (CNBC)
  • Epic’s AI overhaul promises to address EHR headaches for clinicians and patients (STAT)
  • AdvaMed urges Dr. Oz to speed Medicare coverage of breakthrough devices (MedTech Dive)
  • More than 1,100 devices have received the FDA’s breakthrough designation (MedTech Dive)
  • Hip Resurfacing For Women: Embody Orthopaedic Awarded CE Mark For H1 Implant (MedTech Insight)
Food & Nutrition
  • The Infant Food Revolution: Whole Foods Before Teeth (Bloomberg)
  • Trump administration to explore limits on advertising unhealthy foods to kids (Food Dive)
Government, Regulatory & Legal  
  • How Deeply Trump Has Cut Federal Health Agencies (ProPublica)
  • What updated thresholds for statin use could mean for patients (STAT)
  • Congress must continue to support the VA’s research into psychedelics for PTSD (STAT)
  • Masimo sues US Customs over approval of Apple Watch imports (Reuters)
  • Healthcare costs to go up 9% in 2026 for large employers (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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