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May 21, 2024
by Jason Scott

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