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July 30, 2024
by Michael Mezher

Recon: Pfizer raises profit forecast on cancer, heart drug sales amid declining COVID revenue; Sanofi sues Sarepta over gene therapy patents

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Patients push back against Novo Nordisk move to scrap an insulin product (Reuters)
  • Ozempic linked to less tobacco-related healthcare use in study (Reuters)
  • Pfizer lifts profit forecast on strong sales of cancer, heart drugs (Reuters)
  • Sanofi sues Sarepta over US patents for gene therapy treatments (Reuters)
In Focus: International
  • Novo's older obesity drug shows biological effect on Alzheimer's patients in small trial (Reuters)
  • BioNTech's cancer drug meets primary endpoint in Phase 2 trial (Reuters)
  • Grifols takes $494 mln writedown on Chinese investment (Reuters)
  • Concern over Merck's Gardasil sales in China sink shares (Reuters)
  • Italy's Recordati hikes 2024 guidance after core profit rises 11.5% (Reuters)
  • Granules India's Q1 profit nearly triples on strong demand (Reuters)
Pharma & Biotech
  • How artificial intelligence can bolster Europe’s competitive edge in biopharma (STAT)
  • Incyte touts 2 trial wins for PD-1 drug Zynyz, eyes comeback in anal cancer (Fierce)
  • EU To Launch New Platform For Tackling Shortages Of ‘Critical’ Medicines In Health Crises (Pink Sheet)
  • EU Pilot On Raw Data Analysis Shows Benefits For Streamlining Medicines Evaluation (Pink Sheet)
  • Imunon shares up over 150% as ovarian cancer treatment extends survival in Phase 2 (Endpoints)
  • Celldex says antibody drug improves irritable skin condition in Phase 2 test (Endpoints)
  • Startup aims to tackle ‘undruggable’ neuro targets with tech from Kevan Shokat's UCSF lab (Endpoints)
  • Keytruda tops $7B quarterly sales for the first time (Endpoints)
Medtech
  • Italy's Amplifon posts flat Q2 net profit on weak Europe demand (Reuters)
  • Dialysis firm FMC cuts outlook for US treatment volumes, shares fall (Reuters)
  • FDA officials outline benefits of AI lifecycle management (MedtechDive)
  • Hologic quarterly profit rises on strong demand for its women's health products (Reuters)
  • The Case For Quality: The Value Of The Voluntary Improvement Program (MedtechInsight)
  • Verily to relocate its HQ from San Francisco to Dallas (Fierce)
  • Patient shares a day in the life with diabetes at FDA’s first Home Health Hub meeting (MedtechDive)
Government, Regulatory & Legal
  • How Orange Book Antitrust Scrutiny Is Intensifying (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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