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)
- 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)
- 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)
- 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)
- The Infant Food Revolution: Whole Foods Before Teeth (Bloomberg)
- Trump administration to explore limits on advertising unhealthy foods to kids (Food Dive)
- 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)
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