Anti-NGF Trials Might Resume With Very Narrow Patient Populations

FDA’s Arthritis Advisory Committee suggests strictures that could be so strong as to discourage the resumption of clinical trials of Pfizer’s tanezumab, Regeneron’s REGN475 and Janssen’s fulranumab.

The Arthritis Advisory Committee suggested that FDA impose much stricter safety criteria on studies of anti-nerve growth factor agents than what the sponsors said they would contemplate, causing some panel members to wonder aloud whether there may be practical problems implementing them.

“I think we can all agree that risk minimization measures need to be practical and realistic to conform with routines of clinical care,” Elaine Morrato, Colorado

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

More from North America