Recon: Drugmakers sink after Marks’ ouster; Lilly’s drug slashes genetic heart disease risk in late-stage trial
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- It’s RFK Jr.’s FDA now (STAT)
- Peter Marks, FDA’s top vaccine regulator, forced out (STAT)
- New FDA commissioner agreed to oust top vaccine regulator after private swearing-in (Politico)
- Ouster of FDA’s Peter Marks alarms a biopharma industry that saw him as an ally (STAT)
- Drugmakers sink after key FDA official ousted as Trump plans health overhaul (Reuters)
- HHS emergency response unit given two days to figure out its fate (STAT)
- Trump chooses Fox News contributor Sara Carter as next drug czar (STAT)
- Drugmakers sink after key FDA official ousted as Trump plans health overhaul (Reuters)
- Experimental Lilly drug cuts genetic heart disease risk factor by 94% in trial (Reuters)
- Eli Lilly’s Alzheimer’s drug gets thumbs-down from European regulators (STAT)
- European institutions target ‘scientific asylum-seekers’ from US (The Hill)
- Chinese brain chip project speeds up human trials after first success (Reuters)
- Lassa fever kills 118 in Nigeria over last three months (Reuters)
- WHO proposing to cut jobs and slash budget by a fifth, memo shows (Reuters)
- Emotional whiplash for PTC Therapeutics (STAT)
- Novo Nordisk sets sights on new type of oral obesity drug (STAT)
- Alphabet’s Isomorphic Labs raises $600M in biotech’s largest round of 2025 (Endpoints)
- Inspirna, which was preparing for a Phase 3 cancer trial, has folded (Endpoints)
- Lilly's heart disease drug could be dosed as little as once a year, study shows (Endpoints)
- Corcept's ovarian cancer drug cuts disease progression in study, shares jump (Reuters)
- Exclusive: Transcend notches Phase 2 win to treat PTSD, invigorating budding neuroplastogen class (Endpoints)
- BiomX’s phage therapy succeeds in Phase 2 diabetic bone infection study (Endpoints)
- Exclusive: SV Health debuts Parkinson's biotech with backing from AbbVie and others (Endpoints)
- Vertex’s second-generation diabetes cell therapy fails early-stage study (Endpoints)
- FDA OKs first at-home test for 3 STIs (MedTech Dive)
- Tandem eyes Medicare coverage expansion for Type 2 (MedTech Dive)
- How Cutting Edge Technology Is Changing Risk Management In the EU (MedTech Insight)
- LSI 2025: Vektor Medical CEO Says ‘Arrhythmia Is The Biggest Health Care Crisis Nobody Talks About,’ vMap Treats It With 91.1% Accuracy (MedTech Insight)
- Requirements for Mandatory Foodborne Pathogen WGS Analysis, Data Submission in EU (Food Safety)
- Boar’s Head Appoints Natalie Dyenson as Chief Food Safety Officer (Food Safety)
- Utah bans fluoride in public drinking water, a first in the U.S. (STAT)
- Amgen loses its battle against Colorado over a prescription drug affordability board (STAT)
- Big Tobacco targets Trump in hope - and fear - of change (Reuters)
- It’s a Bird, It’s a Plane, It’s Operation Stork Speed (FDA Law Blog)
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