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September 4, 2025
by Jason Scott

Recon: Prasad overruled staff on COVID vaccine eligibility; Congo declares Ebola outbreak

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Kennedy defends CDC shakeup in closely watched Senate hearing (STAT)
  • US Senators pit Kennedy vaccine policy against Trump's Operation Warp Speed (Reuters)
  • Big shakeups to the childhood vaccination schedule could be nearing (STAT)
  • After ousting CDC’s director, RFK Jr. mirrors her ideas to reform the agency (STAT)
  • FDA Official Overruled Scientists on Wide Access to Covid Shots (The New York Times)
  • FDA delays decision on Agios drug in thalassemia over liver safety (Endpoints)
  • Ousted CDC head says she was pressured to preapprove vaccine panel recommendations (Reuters)
  • Kennedy picks seven new members for US CDC vaccine panel, document shows (Reuters)
  • Trump Pollster Briefed Republicans on Support for Vaccines (Bloomberg)
In Focus: International                                                                                                       
  • India looking beyond US for pharma exports amid tariff tensions (Reuters)
  • India's drug regulator eyes lighter oversight, more AI to boost efficiency (Reuters)
  • Congo Declares Ebola Virus Outbreak as 15 Deaths Reported (Bloomberg)
  • Edwards, Medtronic and Abbott stand to benefit from new TAVR guidelines in Europe (MedTech Dive)
  • Salient Bio Raises £2.35M For March 2026 Rollout Of At-Home IBD Microbiome Test (MedTech Insight)
Pharma & Biotech
  • Pfizer, Moderna defend COVID vaccine effectiveness after Trump remarks (Reuters)
  • For a deadly metastatic site, proton beam radiation therapy may improve survival (STAT)
  • Biotech VC raises $400 million ‘opportunity’ fund in sign of possible industry rebound (STAT)
  • Sanofi shares drop after disappointing trial results (STAT)
  • Amneal Pharma is scolded by FDA for using contaminated bags for a sterile injectable drug (STAT)
  • Is biotech back? Don’t jinx it, but the signs are encouraging (STAT)
  • AC Immune culls pipeline, lays off 30% of staff to extend cash runway further into 2027 (Endpoints)
  • MindMed publishes Phase 2b LSD data, with execs bullish about distinction from Spravato (Endpoints)
  • Exothera shutters; Lotte Biologics’ latest contract with an unnamed US client (Endpoints)
  • Avadel's $20M upfront for sleep drug; Congruence gets $32M for obesity drug (Endpoints)
  • Novo Has High Hopes That Ozempic Pill Can Also Fight Dementia (Bloomberg)
  • Monogram Sets Sept. 30 Shareholder Vote on $177M Zimmer Biomet Deal, $11M Fee If Terminated (MedTech Insight)
Medtech
  • Renal denervation gets strong backing from cardiologists ahead of Medicare coverage decision (MedTech Dive)
  • Kardium receives FDA OK for pulsed field ablation system (MedTech Dive)
  • Highridge Medical CEO Whitney On Accelus Buys And Spine Strategy (MedTech Insight)
  • Fairtility’s FDA-Cleared CHLOE Brings AI To Embryo Selection (MedTech Insight)
Food & Nutrition
  • Major report that tied moderate drinking to disease won’t be released, researchers say (STAT)
  • Campbell’s becomes latest food giant to remove synthetic colors (Food Dive)
Government, Regulatory & Legal  
  • Fired members of the CDC vaccine advisory committee: Americans are losing the ability to choose vaccination (STAT)
  • Florida plans to end all state vaccine mandates, including for schools (Reuters)
  • Texas lawmakers pass bill allowing private citizens to sue abortion pill distributors (Reuters)
  • Massachusetts Allows Pharmacies to Give New Covid Vaccines (Bloomberg)
  • Cannabis Redux: Marijuana Rescheduling Act Reintroduced in the U.S. House (FDA Law Blog)
  • Over 1,000 HHS employees call for RFK Jr. to step down (MedTech Dive)
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.
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