Recon: FDA approves Vertex gene therapy for children with sickle cell disease; Judge blocks Colorado price cap on Amgen’s Enbrel
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA approves Orca Bio’s T cell therapy for blood cancer patients (STAT)
- US FDA approves Vertex's gene therapy for sickle cell disease in children as young as two (Reuters)
- Judge blocks Colorado's first-of-its-kind price cap on Amgen's Enbrel (Reuters)
- US blocks quick USMCA extension, putting annual review process into motion (MedTech Dive)
In Focus: International
- AstraZeneca signs CSPC China deal for experimental kidney disease drugs (Reuters)
- BrightGene looks to the West as obesity shot nears China approval (Endpoints)
- UK Healthcare Cyberattacks Surge Tenfold In 2026, But Ransomware Stays Absent (MedTech Insight)
- Marburg outbreak is reported in Uganda, threatening to complicate Ebola response in region (STAT)
- What Ebola and Marburg are teaching us about the next pandemic (STAT)
Pharma & Biotech
- AI company Anthropic announces it will begin developing drugs of its own (STAT)
- Statins and blood pressure drugs changing health risks of obesity, study suggests (STAT)
- Synthetic biology researchers think they’ve made a cell. Is it alive? (STAT)
- Abivax nears $11 billion valuation after fundraising eases M&A pressure (Reuters)
- Older Americans left out of costly GLP-1 craze expected to flock to new program (Reuters)
- Roche’s KRAS G12C inhibitor beats rivals in head-to-head Phase 3 study (Endpoints)
- BridgeBio adds $1B as it prepares three more drug launches (Endpoints)
- Merck scraps a Phase 2 Alzheimer's asset from partner Neuphoria (Endpoints)
Medtech
- How Butterfly, once known for its handheld ultrasound device, is growing its chip-making business (MedTech Dive)
- FDA authorizes more devices so far in 2026, but it’s taking longer (MedTech Dive)
- FDA updates Hologic BioZorb recall, citing 252 injuries (MedTech Dive)
- Spinal Cord Stimulator Plaintiffs Allege Harm Far Beyond Device Failure (MedTech Insight)
Food & Nutrition
- Booze schmooze: The alcohol industry, frazzled by headwinds, wields its power behind the scenes (STAT)
- 7 takeaways from STAT’s investigation into the U.S. alcohol epidemic (STAT)
Government, Regulatory & Legal
- DEA moves to place some strong kratom-related products under strict federal drug controls (Reuters)
- Medicare's new $50 weight-loss drug program: Who qualifies and what are the concerns? (Reuters)
- Alibaba to pay $600 million to resolve US drug sales probe (Reuters)
- Terumo’s Global RelayPro Recall Tests Aortic Franchise Amid Record Year (MedTech Insight)
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.
