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February 10, 2026
by Jason Scott

Recon: FDA denies Regenxbio’s gene therapy for Hunter syndrome; Moderna signs deal to manufacture mRNA vaccines in Mexico

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Trump administration revives effort to launch pilot initiative reworking drug discount program (STAT)
  • GLP-1s Likely TrumpRx Savings Focus Over Old, Genericized Products (Pink Sheet)
  • The new childhood vaccine guidelines have a paid leave problem (STAT)
  • 'Bat-sh*t crazy': Biopharma leaders unload on regulatory chaos (Endpoints)
  • FDA rejects Regenxbio's Hunter syndrome gene therapy (Endpoints)
  • Measles cases in South Carolina rise by 13 to 933, state health department says (Reuters)
  • FDA untitled letters target drug ads from Novo, argenx, Sobi (Fierce Pharma)
In Focus: International
  • Shanghai's Cascade gets $72M to pursue MASH, obesity and diabetes drugs (Endpoints)
  • Hengrui, Kailera push obesity pill ahead on promising mid-stage China data (Endpoints)
  • With scant data, RFK Jr. credits Trump tariffs for higher drug prices in Europe (Endpoints)
  • Illumina Looks To Clinical Consumables And China Restart To Offset Intensifying NGS Price Pressure (MedTech Insight)
  • EMA Backs Smarter Tool To Spot Pregnancy‑Related Medicine Risks (Pink Sheet)
  • Moderna inks long-term pact with Mexico to bolster local mRNA vaccine supply (Fierce Pharma)
Pharma & Biotech
  • The fallout from Novo vs. Hims (Endpoints)
  • Abridge CTO talks Epic, Microsoft, and rebranding as ‘more than an AI scribe’ (STAT)
  • Eczema drug from Nektar Therapeutics maintains skin responses in one-year study (STAT)
  • Biotech doubles financing in quest to silence genes behind neurological diseases (STAT)
  • Is AstraZeneca on track to meet its $80B revenue target? (Endpoints)
  • CSL’s CEO Paul McKenzie exits after rough few years (Endpoints)
  • AstraZeneca’s obesity pill hits in Phase 2, key cancer trials pushed back (Endpoints)
  • Kailera, Hengrui's experimental pill shows 12.1% weight loss in mid-stage trial (Reuters)
  • Novartis CEO pay soars 30% to $32M following record-breaking 2025 performance (Fierce Pharma)
  • As Jakafi approaches generic competition, Incyte counts more on Opzelura (Fierce Pharma)
Medtech
  • Quest Diagnostics forecasts 2026 profit, revenue above estimates on lab test demand (Reuters)
  • Baxter cuts roughly 90 jobs at IV solutions plant that recovered from Hurricane Helene (MedTech Dive)
  • Stryker starts limited release of Mako RPS handheld knee robot (MedTech Dive)
  • Philips Sets 3-Year Growth Plan And Ends 2025 On A Comparative High (MedTech Insight)
Food & Nutrition
  • US FDA to review decades-old food preservative in safety overhaul (Reuters)
  • FDA must be more transparent about outbreak investigations (Food Safety News)
Government, Regulatory & Legal
  • Federal government turns to fresher data to rein in Medicare Advantage upcoding (STAT)
  • National Cancer Institute studying ivermectin’s ‘ability to kill cancer cells,’ alarming career scientists (STAT)
  • OHSU board votes to negotiate with NIH and possibly transform its primate center into an animal sanctuary (STAT)
  • US House panel issues subpoenas to eight health insurers on alleged Obamacare fraud (Reuters)
  • CVS Health keeps in place 2026 forecast, eyes topping it (Reuters)
  • Registered EMS Agencies: The New Kid on the DEA Block (FDA Law Blog)
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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