Pfizer Inc.'s 10-year Celebrex (celecoxib) cardiovascular study culminated in a US FDA advisory committee vote supporting a label change that could boost sales of the COX-2 inhibitor. But the panel discussion showed some of the trial's limitations and the difficulties in doing a large population-based study.
Celebrex PRECISION Trial: 'Herculean' Effort, But Missing Information Bugs US FDA Panel
Pfizer study finds Celebrex's CV risk comparable to naproxen and ibuprofen, but advisory committee wanted data on confounding factors and reasons for high dropout.
More from US FDA Performance Tracker
• By
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
• By
March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
• By
The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.
• By
The US FDA is receiving more requests for regenerative medicine advanced therapy designation and granting more of them, according to recently reported agency data.
More from Regulatory Trackers
• By
March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
• By
The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.
• By
The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.