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)
- 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)
- 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)
- 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)
- 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)
- 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)
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