Recon: FDA rejects Aldeyra’s eye disease drug; Senate confirms Dr. Oz to lead CMS
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
Trump administration begins mass cuts of federal health policy researchers (STAT)
US Senate confirms Trump's Medicare and Medicaid nominee Mehmet Oz (Reuters)
Inquiry by New York congressman reveals frustration over UnitedHealth practices in Hudson Valley (STAT)
Five NIH institute directors and numerous lab heads ousted in unprecedented shake-up (STAT)
Decimation of HHS comms, FOIA offices will leave Americans in the dark about urgent health matters (STAT)
Chaotic tariff rollout leaves as many questions as answers for drugmakers (Endpoints)
Trump’s broad tariffs exempt pharma — but for how long? (Endpoints)
US FDA approves Amgen's Uplizna as first treatment for rare immune disorder (Reuters)
US FDA declines to approve Aldeyra's eye disease drug (Reuters)
US FDA misses deadline for decision on Novavax's COVID-19 vaccine (Reuters)
Cantor analysts double down on Kennedy criticism as FDA jobs cuts begin (Reuters)
In Focus: International
Small-town Ireland nervous as Trump seeks to lure pharma investment to US (Reuters)
Bidding war for UK healthcare REIT Assura heats up after new $1.96 billion bid (Reuters)
Early Randomization Among Advice On How To Meet Both EMA & HTA Needs (Pink Sheet)
AI Could Be Used ‘In The Deliberation’ Of HTA Reviews In England, Says NICE (Pink Sheet)
Swiss Blast US Import Tariffs As Medtechs Look For Dialog To Forestall Damage To Industry (MedTech Insight)
Pharma & Biotech
Pharma stocks survive market rout on tariff exemption, but uncertainty continues (Reuters)
The Johnson & Johnson cancer drug scandal that encapsulates corruption in health care (STAT)
Vida Ventures brings in new leaders after co-founders’ departure (STAT)
Sarepta, Roche pause Elevidys trials in Europe following patient death (Endpoints)
Exclusive: Neurona bags $102M to treat epilepsy with cell therapy (Endpoints)
Q&A: John Crowley warns biotech is 'dangerously close' to breaking, as tariff threat, markets batter industry (Endpoints)
Novartis’ Chinook-originated kidney disease drug gets accelerated approval (Endpoints)
FDA cuts stir buyer’s remorse for some biopharma leaders, once excited by Trump (Endpoints)
MoonLake discloses up to $500M in financing; OSR’s deal with innovation fund (Endpoints)
Novo Nordisk's head of commercial strategy steps down (Reuters)
Medtech
Every doctor is a writer: On the end of note-writing and meaning-making in medicine (STAT)
Dartmouth put its AI therapy chatbot through the RCT wringer. Is it better than playing Tetris? (STAT)
Boston Scientific’s Farapulse matches Medtronic cryoablation in trial (MedTech Dive)
‘Just goodbyes and crying’: CDRH hit in HHS mass layoffs (MedTech Dive)
AI-Powered Robotics: Monogram Bets On ‘Active’ Assistance With FDA-Cleared Robotic Knee System To Outperform Stryker’s Haptics (MedTech Insight)
Food & Nutrition
Researchers Develop Predictive Model for Listeria Growth in RTE Artisanal Cheeses (Food Safety)
Government, Regulatory & Legal
What FDA cuts could mean for the future of tobacco (STAT)
Scientists sue NIH, saying politics cut their research funding (STAT)
Why a small journal’s ‘blueprint for NIH’ may offer clues to the agency’s future (STAT)
Makary’s first speech to FDA staff focuses on challenging norms, fighting chronic disease (STAT)
FTC suit over PBMs’ insulin pricing is delayed in part by Trump firings (STAT)
Three Supreme Court health cases to keep an eye on (STAT)
Supreme Court sides with the FDA in its dispute over sweet-flavored vaping products (STAT)
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.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.