Recon: Prasad went against FDA staff to refuse to review Moderna’s flu vaccine; Sanofi ousts Paul Hudson as CEO
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Trump administration revives effort to launch pilot initiative reworking drug discount program (STAT)
- Prasad overruled FDA staff to reject Moderna’s flu vaccine application (STAT)
- The old Vinay Prasad never left. He just changed jobs (STAT)
- How employers feel about the state of healthcare (and GLP-1s) (Endpoints)
- CDC moves to cut $600M in grants to Democrat-led states (MedTech Dive)
- Dozens of Democrats call for removal of newly appointed OB-GYNs from vaccine advisory panel (The Hill)
- European VCs band together to improve the landscape for biotech startups (STAT)
- Even Europeans don't see a future in Euro biopharma anymore: Endpoints Signal (Endpoints)
- In Mexico, at least 28 have died from measles outbreak that started 2025 (Reuters)
- Bringing Net Zero Onto The Radar For UK Healthtech Innovators (MedTech Insight)
- Talkiatry raises $210 million, eyeing opportunity to use AI for engaging with patients (STAT)
- Big Health raises funding as investors see glimmer of hope for digital therapeutics (STAT)
- BridgeBio drug for genetic cause of dwarfism succeeds in key study (STAT)
- Paul Hudson out as Sanofi CEO (STAT)
- Terray says its AI model beats a popular open-source model at predicting how molecules bind with proteins (Endpoints)
- In a first, one CAR-T therapy is going up directly against another in trial (Endpoints)
- Utah startup Leash Bio warns AI models could 'cheat' in biology. It bets its own 'dinky' model shows the way forward (Endpoints)
- CSL's bleak earnings report helps explain why it made CEO switch (Fierce Pharma)
- J&J’s Tremfya roars into 2026 with massive TV ad spend, trailed by AbbVie’s Rinvoq and Skyrizi (Fierce Pharma)
- FDA Approves First Home-Use Pancreatic Cancer Treatment Device (MedTech Insight)
- US import block on vapes could cut illegal sales by a third, BAT says (Reuters)
- Neurent raises $74M to commercialize treatment for nasal condition (MedTech Dive)
- AdvaMed names Melissa Torres as new leader for technology and regulatory affairs (MedTech Dive)
- Zimmer plans US salesforce reorganization (MedTech Dive)
- Edwards focuses on earlier TAVR adoption (MedTech Dive)
- Solace Health Raises $130M In Series C Round Bringing It To $1Bn Valuation (MedTech Insight)
- FDA to reassess safety of snack food preservative BHA (Food Dive)
- Fresh produce has a messaging problem (Food Dive)
- RFK Jr's vaccine agenda faces Boston judge who has handed Trump setbacks (Reuters)
- Drug injection fades as smoking grows more common, marking sea change in U.S. fentanyl epidemic (STAT)
- Students, faculty mystified as NSF turns back applications for prestigious fellowship program (STAT)
- Four states sue Trump administration over cuts to public health funding (Reuters)
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