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August 6, 2024
by Michael Mezher

Recon: GSK prevails in Illinois Zantac suit; Baxter lifts forecast on strong device demand

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • GSK wins latest trial over Zantac cancer claims (Reuters)
  • Jeff Shuren stabilized the FDA’s medical devices center, winning over industry but not all patients (STAT)
  • Baxter raises full-year profit forecast on robust demand for medical devices (Reuters)
  • Harris’ running mate, Minnesota Governor Tim Walz, boasts progressive health care record (STAT)
  • ‘Jerking families around’: Canceled Roche rare disease trial devastates parents, angers researchers (STAT)
  • BioMarin scales back launch for hemophilia gene therapy, pitches path to profitability (Endpoints)
  • What Washington wants in Cures 2.0 (Politico)
In Focus: International
  • China to beef up regulations on fentanyl chemicals, White House says (Reuters)
  • India's Gland Pharma posts surprise fall in Q1 profit on soaring employee costs (Reuters)
  • Sanofi: England Needs ‘Flexible’ Pricing For Multi-Indication Drugs (Pink Sheet)
  • Japanese government grants Shinobi $59M for cell therapy development (Endpoints)
  • Bayer details 3,200 job cuts so far, spotlights ‘momentum’ in pharma pipeline (Endpoints)
Pharma & Biotech
  • Biotech VCs are pacing for another record-low year of fundraising amid glimpses of recovery (STAT)
  • EU Helps Firms To Prioritize Submission Of Data On ‘Critical’ Drugs (Pink Sheet)
  • Zoetis lifts 2024 results forecasts on strong demand for pet treatments (Reuters)
  • Ex-Pfizer drug reduces osteoarthritis pain in British biotech's phase 2 study (Fierce)
  • Former Biden White House health official joins Flagship Pioneering (STAT)
  • Merck advances lung cancer attack, pocketing $170M from Daiichi and plotting ADC-trispecific combo (Fierce)
  • Gaps Found In Most Pharma Trial Diversity Policies (Pink Sheet)
  • Exclusive: Covid and epidemic threat biotech Aerium Therapeutics closes after emergence of variants (Endpoints)
  • Ultimovacs’ cancer vaccine flunks again — this time in head and neck cancer (Endpoints)
  • Eisai picks SEED Therapeutics for molecular glue deal worth as much as $1.5B (Endpoints)
  • Bicycle Therapeutics focuses pipeline and streamlines leadership team (Endpoints)
  • Hims takes steps to lock up drug supply for its booming weight loss business (Endpoints)
  • Genentech partners with cash-strapped Sangamo on epigenetic Alzheimer’s therapy (Endpoints)
Medtech
  • FDA seeks feedback on health equity for medical devices (MedtechDive)
  • Ascensia’s new head of CGM talks plans for a 365-day sensor (MedtechDive)
  • J&J To Launch Velys Spine Platform After Securing FDA Clearance (MedtechInsight)
Government, Regulatory & Legal
  • Novartis, Viatris face new lawsuit over 'HeLa' cell misuse claims (Reuters)
  • CooperSurgical Says Lab Hid Flawed IVF Product Tests (Law360)
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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