Recon: White House adds Amazon, GoodRx, and Cost Plus to TrumpRx; Merck reports survival benefit in late-stage uterine cancer study
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Maryland state affordability board places a price cap on Ozempic (STAT)
- Trump’s CMS to allow skimpier plans on ACA exchanges (STAT)
- U.S. bans entry from Ebola-affected countries as American patient is identified (STAT)
- White House taps Amazon, GoodRx, and Mark Cuban to bolster TrumpRx (STAT)
- Health experts meet in search of Ebola Bundibugyo vaccine options (Reuters)
- Trump bought stock in drugmaker as admin boosted its obesity drugs (Fierce Pharma)
- FDA's unreleased Covid vaccine deaths report is published by lawmaker (Endpoints)
In Focus: International
- The China question is tearing biotech apart (STAT)
- Ebola deaths in eastern Congo rise to 131 as outbreak spreads (Reuters)
- WHO awaits six tons of Ebola supplies to Congo as outbreak grows (Reuters)
- WHO chief concerned at speed and scale of Ebola outbreak (Reuters)
- Novartis terminates plant contract with Chinese CDMO Porton, threatens $64M in legal claims (Fierce Pharma)
Pharma & Biotech
- Merck's drug helps uterine cancer patients live longer in late-stage trial (Reuters)
- With no approved vaccine for Ebola outbreak, experts weigh testing a long shot (STAT)
- Relay's PI3Kα inhibitor clears efficacy bar in Phase 2 vascular anomalies study (Endpoints)
- Amgen stands by Tavneos, despite reports of 20 deaths in Japan (Endpoints)
- After key trial fail, Regeneron reaches $125M Parabilis deal for hard-to-catch drug targets (Endpoints)
Medtech
- Natera wins FDA approval for companion diagnostic (MedTech Dive)
- Embecta closes Owen Mumford acquisition for up to $201M (MedTech Dive)
- Europe Cautiously Moves Toward PCCP Implementation (MedTech Insight)
- Perspective: What Architecture Tells Us About Safely Navigating Generative AI Risks in Medtech (MedTech Insight)
Food & Nutrition
- China bans import of pigs, wild boar from the Philippines due to swine fever (Reuters)
- Nourish raises $100M for virtual nutrition care (Endpoints)
- Getting reformulation right: How food companies are rethinking ingredients to (Food Dive)
- Brazil Sends Cheap Soy Oil Abroad as Biodiesel Plan Stalls (Bloomberg)
Government, Regulatory & Legal
- I’m a heart transplant recipient. I’m haunted by ‘ghost approval’ for medication I need to survive (STAT)
- Takeda slapped with $885M verdict in pay-for-delay antitrust case (Fierce Pharma)
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.
