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February 13, 2025
by Jason Scott

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)
In Focus: International                                                                                                       
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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
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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