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)
- 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)
- 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)
- 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)
- US FDA to review decades-old food preservative in safety overhaul (Reuters)
- FDA must be more transparent about outbreak investigations (Food Safety News)
- 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)
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