Recon: Prasad returns FDA as CBER chief; FDA grants priority review for GSK’s gonorrhea antibiotic
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Vinay Prasad returns to the FDA, weeks after his ouster (STAT) (Reuters) (Politico) (Bloomberg)
- In internal FDA town hall, employees raise concerns about staffing, impromptu expert meetings (STAT)
- Exclusive: Medical journal rejects Kennedy's call for retraction of vaccine study (Reuters)
- CureVac and GSK to receive money and royalties from BioNTech/Pfizer as part of mRNA patent settlement (Endpoints)
- GSK's antibiotic gets FDA priority review for oral treatment of gonorrhoea (Reuters)
- Swiss government to meet pharma firms to discuss US tariffs (Reuters)
- EU4Health Boost For Orphan Devices And SMEs (MedTech Insight)
- Roche Eyes 2026 FDA Nod After CE Mark For pTau181 Test To Boost Global Alzheimer’s Diagnosis (MedTech Insight)
- Novo, Orsted Woes Make Danish Stock Benchmark the World’s Worst (Bloomberg)
- Alnylam could be the next mega-cap biotech (STAT)
- Medical journal rejects Kennedy's call for retraction of vaccine study (Reuters)
- IO Biotech's cancer vaccine shows improvement, but narrowly misses study goal (Reuters)
- Novartis plans Sjögren’s disease filings as antibody passes two Phase 3 studies (Endpoints)
- FDA restricts use of bluebird's gene therapy Skysona due to increased blood cancer risk (Endpoints)
- Former Biotech Raising $1.5 Billion to Hoard Trump-Tied Token (Bloomberg)
- FDA Formally Rescinds the LDT Final Rule Following Defeat in Court (FDA Law Blog)
- Apreo raises $130M for pivotal trial of emphysema device (MedTech Dive)
- Boston Scientific updates instructions of devices linked to 17 deaths (MedTech Dive)
- Tandem, Insulet monitoring CMS payment proposal for diabetes tech (MedTech Dive)
- Zimmer Biomet Targets 2027 Launch For Semi-Autonomous Orthopedic Robot After Monogram Acquisition (MedTech Insight)
- Survey Reveals Gaps In Medtech Compliance Processes (MedTech Insight)
- Environmental Group Questions FDA’s Stance On PFAS In Medical Devices (MedTech Insight)
- Danone targets consumers taking weight loss drugs with new drink (Reuters)
- Albertsons outlines defense against growing ingredients costs (Food Dive)
- Exclusive: USPS blocks shipping of illicit vapes in boost for Big Tobacco (Reuters)
- Trump’s firing of the Bureau of Labor Statistics commissioner puts crucial health data at risk (STAT)
- CDC shaken after gunman attacks its headquarters (STAT)
- Inside the research machine that helps UnitedHealth protect its Medicare profits (STAT)
- Trump administration launches investigation into Harvard’s federally funded research patents (STAT)
- As Novo Nordisk ramps up lawsuits over Wegovy copies, investors ask where is Hims? (Reuters)
- Updated: HHS official tasked with MAHA relations fired amid hasty rollout of mRNA contract cuts (Endpoints)
- Telehealth Abortions Are Centered in Poor States With Few Options, Study Finds (Bloomberg)
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