Recon: FDA rejects Unicycive's kidney disease therapy; Top FDA gene therapy regulator to step down
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA’s top gene therapy regulator is leaving his role (STAT)
- The loophole in Trump’s obesity drug deal with Eli Lilly and Novo Nordisk (STAT)
- All of Us tests a new approach to collect real-world data for research (STAT)
- US House committee opens investigation into Merck, AbbVie China drug trials (Reuters)
- FDA staff question peptides backed by Kennedy ahead of advisory panel review (Reuters)
- Trump's push for the world's lowest drug prices hits snag with mid-sized companies (Reuters)
In Focus: International
- Eli Lilly transfers commercialization rights for breast cancer drug in China (Reuters)
- Ebola outbreak could cost Africa up to $3.6 billion, UN says (Reuters)
- Africa CDC seeks $18 million in urgent support for Ebola drug trials in DRC (Reuters)
- India Initiates Anti-Dumping Probe Into Dialyzer Imports From China, Malaysia (MedTech Insight)
Pharma & Biotech
- Abivax seeks to ease safety concerns with new data, boosting shares (STAT)
- US FDA declines to approve Unicycive's kidney disease drug (Reuters)
- Hybio's generic weight-loss drug set for FDA review (Reuters)
- Vistagen's anxiety disorder drug misses main goal in late-stage trial, shares plummet (Reuters)
- Exclusive: Akeso pushes back on ASCO questioning of lung cancer drug (Endpoints)
- Medical journal retracts Tavneos pivotal study article, complicating Amgen’s defense effort (Fierce Pharma)
Medtech
- J&J starts pivotal trials of Shockwave IVL device in carotid arteries (MedTech Dive)
- FDA Blocks Data From Third Chinese Lab (MedTech Insight)
- Zimmer to buy Pacira pain relief device for up to $140M (MedTech Dive)
- DePuy Synthes names CFO ahead of J&J split (MedTech Dive)
- Edwards wins FDA clearance for LAA clip, setting up competition with AtriCure and Medtronic (MedTech Dive)
- FDA Approves United Therapeutics’ LungFX For Centralized Lung Perfusion, On A Narrow Indication (MedTech Insight)
Food & Nutrition
- How the Trump administration derailed alcohol addiction research and prevention (STAT)
- Challenger food brands are standing out despite fewer marketing swings (Food Dive)
Government, Regulatory & Legal
- AstraZeneca to pay $34 million to settle kickback charges filed by Texas attorney general (STAT)
- FDA allows Philip Morris to market Zyn as less harmful than cigarettes (Reuters)
- 26 states sue to block Medicaid work requirements (STAT)
- 5 takeaways from STAT’s investigation into microhospital operator Nutex Health (STAT)
- Health AI caution crosses into confidence (Endpoints)
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.
