Recon: FDA OKs xenotransplantation clinical trial from United Therapeutics; Trump tariffs may raise cost of drugs and devices
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA approves first xenotransplantation clinical trial, as United Therapeutics forges ahead (STAT)
- How Trump’s tariffs may raise health care costs, from medical devices to prescription drugs (STAT)
- Democratic senators press RFK Jr. about ethics issues ahead of committee vote (STAT)
- RFK Jr. says U.S. won’t threaten pharmaceutical patents to push for lower drug prices (STAT)
- Smaller US winter COVID wave adds pressure to Pfizer turnaround (Reuters)
In Focus: International
- DeepSeek signals China’s rising influence in AI — and AI drug development (STAT)
- WHO says 6 contacts of Ugandan Ebola patient are ill, vaccination efforts could begin Sunday (STAT)
- WHO proposes budget cut after US exit, defends its work (Reuters)
- AstraZeneca ditches UK investment over cut in state support (Reuters)
- No plan to prop up global health, Novo Nordisk Foundation says, as Trump freezes US aid (Reuters)
- German IVD Industry’s Election 2025 Priorities: IVDR Reform, POC Push And Better Reimbursement (MedTech Insight)
- Withdraw AI Liability Proposal, Medtech Industry Tells EU Policymakers (MedTech Insight)
- AI-Powered Patient Alert System Can Save Time, And Lives (MedTech Insight)
Pharma & Biotech
- CAR-T cells can arm other immune cells with engineered proteins to fight cancer, study says (STAT)
- Drugmakers seize on biomarkers to test the FDA's rare disease shift (Endpoints)
- Exclusive: German biotech declares Phase 2 win for non-opioid drug for neuropathic pain (Endpoints)
- Sionna seeks $135M IPO to fuel tests of cystic fibrosis drug candidates (Endpoints)
- Irish startup reports mid-stage victory for short-acting psychedelic drug in depression (Endpoints)
- Tectonic to raise $185M; Acelyrin drops rights to Affibody drug (Endpoints)
- Australian biotech AdvanCell nabs $112M Series C for radiopharmaceuticals (Endpoints)
Medtech
- HPV self-collection tests must be approved for use at home (STAT)
- EssilorLuxottica receives FDA clearance for its Nuance audio glasses (Reuters)
- Thermo Fisher to lay off 300 workers at two viral vector factories (Endpoints)
- Becton Dickinson Plans Life Sciences Segment Separation (Bloomberg)
- Troy Tazbaz, CDRH digital health leader, resigns (MedTech Dive)
- FDA warns about patient monitor cybersecurity vulnerabilities (MedTech Dive)
- Beta Bionics raises $204M in IPO (MedTech Dive)
- Angle Shares Up After New Research Released In Partnership With Illumina (MedTech Insight)
Government, Regulatory & Legal
- National Science Foundation restores payments after five-day pause, but worries over science funding persist (STAT)
- Nobel laureates call on National Academies and biotech CEOs to speak out against Trump attacks on science (STAT)
- Q&A: How gluten-free processed foods put people with celiac disease at risk (STAT)
- RFK Jr. is giving his son any fees he earns from Gardasil vaccine litigation (STAT)
- CDC removal of databases on sexual orientation, gender identity sparks alarm (STAT)
- CDC orders pullback of new scientific papers involving its researchers, source says (Reuters)
- Cigna links executive pay to customer satisfaction as insurers face scrutiny (Reuters)
- Pharmacy Law and Licensing Highlights 2025 (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.
