EU Approval Decision Delay For BMS’s Ozanimod

Company Needed More Time To Answer Questions On New MS Product

BMS should find out mid-2020 whether its new MS drug will be approved in the EU.

Question marks
Companies sometime ask for extra time to address regulators' questions • Source: Shutterstock

Bristol-Myers Squibb has pushed back by one or two months its estimate of when it expects to hear whether ozanimod, the company’s potential new treatment for relapsing/remitting multiple sclerosis, is likely to secure marketing approval in the EU. 

A regulatory decision by the European Medicines Agency is expected mid-2020. If the EMA recommends in favor of approval, formal...

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 Europe

More from Geography

‘Clean Sweep’ Of US CDC Vaccine Committee Puts Kennedy In Driver’s Seat

 

With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."

Generic Drug Office’s Policy Staff Returning To US FDA

 

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.