Recon: FDA staff find Guardant test may not identify certain pre-cancerous tumors; AstraZeneca targets $80B in revenue and 20 new therapies by 2030
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- PBM executives invited to testify before House panel (STAT)
- Lyra to lay off 75% of its workers; Dupixent nears COPD decision (Endpoints)
- Lilly makes another radiopharma move in collaboration with Aktis Oncology (Endpoints)
- Lilly doubles down on radiopharma (STAT)
- FDA lifts partial clinical hold on Larimar’s Friedreich’s ataxia treatment (Endpoints)
- More Pediatric Cancer Trials Conducted Due To RACE Act (Pink Sheet)
- US FDA Looking To Modernize Clinical Trial Regulations To Spur ‘Evolution’ In Research (Pink Sheet)
- ‘Antiquated’ Regulations Slowing Adoption of Innovative Clinical Trial Approaches (Pink Sheet)
- US FDA staff says Guardant's test may fail to detect some pre-cancerous tumors (Reuters)
- Aktis to collaborate with Eli Lilly on cancer therapies (Reuters)
- European Pharmacopoeia Gets To Grips With Quality Standards for mRNA Vaccines (Pink Sheet)
- France Reveals The Drugs That Are Most Likely To Require Post-Market RWE Studies (Pink Sheet)
- EU To Suspend 17-OHPC Preterm Birth Drugs A Year After US Pulled Makena (Pink Sheet)
- Dexcom Announced Launch Of One+ CGM In UK, State Of Type 2 Report (MedTech Insight)
- GSK’s asthma push continues as drug succeeds in Phase 3 trials (STAT)
- At a flashy new research hub, AstraZeneca lays out ambitious growth goals (STAT)
- AltruBio raises $225 million to develop ulcerative colitis drug and other immune checkpoint enhancers (STAT)
- AstraZeneca counts on ‘difficult-to-copy’ therapies for big 2030 goal and beyond (Endpoints)
- ‘A new era of growth’: AstraZeneca aims for $80B revenue, 20 new drugs by 2030 (Endpoints)
- Hims’ push into compounded GLP-1 drugs risks scrutiny from Novo Nordisk (Endpoints)
- With a fresh $100M, Monte Rosa CEO details plans to move several molecular glues into the clinic (Endpoints)
- Sanofi, OpenAI, Formation Bio announce AI drug development partnership (Endpoints)
- AI biotech Exscientia to trim nearly a quarter of workforce, following pipeline cut and CEO firing (Endpoints)
- AltruBio secures $225M for an updated version of its ulcerative colitis drug (Endpoints)
- Reports of telehealth’s death have been greatly exaggerated (STAT)
- FDA seeks AI tech to predict, detect Parkinson’s symptoms (STAT)
- Medtronic heads into earnings having seen rivals prosper (MedTech Dive)
- Boston Scientific’s cardiac rhythm system hits pivotal trial goals (MedTech Dive)
- Pulsed field ablation poised for fast adoption, analysts say (MedTech Dive)
- J&J posts latest Varipulse data while awaiting FDA review (MedTech Dive)
- Class action against UnitedHealth asks about DOJ probe transparency (STAT)
- As a primary care physician, here’s how I hope to partner with AI (STAT)
- Move over, wastewater. Store-bought milk could be another way to track the bird flu outbreak in cows (STAT)
- Regulatory Overhaul Needed For Innovative Techs, Gottlieb Says (MedTech Insight)
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