Recon: J&J and Sanofi halt E.coli vaccine study over weak efficacy data; Pfizer nabs new FDA indication for Adcetris
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- As Trump pauses enforcement of an anti-bribery law, will pharma engage in bad behavior? (STAT)
- Kennedy to take top US health post after Senate confirmation (Reuters)
- Larry Tabak, NIH’s longtime second-in-command, to retire (STAT)
- NIH’s funding cut plan poses challenges for researchers despite court halt (Endpoints)
- Trump policies spark fears of brain drain, threatening to undermine U.S. dominance in biomedicine (STAT)
- Kaiser Permanente calls on FDA and Congress to firm up accelerated approval requirements (Endpoints)
- J&J, Sanofi stop E.coli vaccine trial due to low effectiveness (Reuters) (Endpoints)
- Pfizer wins approval in new indication for blood cancer drug Adcetris (Endpoints)
- As officials prepare for WHO-led flu vaccine meeting, many wonder: Will the U.S. show? (STAT)
- WHO releases $2 million to support Uganda's Ebola outbreak response (Reuters)
- China says Wuhan institute was not involved in creating COVID-19 virus (Reuters)
- Italian drug maker Recordati boosts 2025 core profit, revenue forecast (Reuters)
- EMA creates advice portal for some high-risk medical devices (Reuters)
- India’s Healthtech Revival: $1.1B Surge In 2024 Signals Renewed Investor Confidence (MedTech Insight)
- Biotech is in a dark place (STAT)
- Newleos, a new biotech with $93.5M, repurposes Roche's experimental CNS drugs (Endpoints)
- Hunger-suppressing biotech Aardvark raises $94M in IPO (Endpoints)
- Neumora shakes up C-suite a month after depression drug fails first Phase 3 trial (Endpoints)
- Astellas shifts investment focus to later-stage opportunities amid reprioritization (Fierce Pharma)
- With $40 million, former DeepMind employees launch startup ‘laser-focused’ on AI protein design (STAT)
- GE HealthCare forecasts upbeat 2025 profit on steady medical device demand (Reuters)
- Medtronic buys Nanovis’ nano technology for use in spine implants (MedTech Dive)
- Judge orders FDA, health agencies to restore removed webpages (MedTech Dive)
- Trump orders agencies to plan for ‘large-scale’ job cuts (MedTech Dive)
- Edwards predicts second-half lift from TAVR label expansion (MedTech Dive)
- Glucotrack Announces Successful First Human Clinical Study For Implanted CGM Device (MedTech Insight)
- People with alcohol-use disorder drank less on Ozempic, small study shows (STAT)
- The FDA must remove an unnecessary barrier to the use of clozapine for treatment-resistant schizophrenia (STAT)
- Young researchers mobilize to protest Trump administration’s science policies (STAT)
- Medicare removes sexual orientation, gender identity questions from enrollment forms (STAT)
- Nestle CEO defends packaged food ahead of Robert F. Kennedy Jr. confirmation (Reuters)
- Into the Ashtray: FDA’s Previous Proposal to Ban Menthol Cigarettes (FDA Law Blog)
- High medical costs have eaten away at CVS Health's earnings all year. There’s no quick fix (Endpoints)
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