Latest From Maureen Kenny
The EU marketing authorization application for Takeda's dengue vaccine candidate is no longer being fast-tracked. Also, five requests for accelerated assessment were decided on at the latest meeting of the European Medicines Agency's drug evaluation committee, the CHMP.
The European Medicines Agency decided this month whether to grant fast-track review for planned marketing authorization applications for four potential new orphan treatments.
Sanofi and GSK are way behind in the COVID-19 vaccine race and the start of a rolling review of Vizprevtyn at the European Medicines Agency is an important step.
EU marketing authorization applications from Bayer for copanlisib and from Takeda for maribavir will be reviewed under standard timelines at the European Medicines Agency.
EU reviewers will decide this week whether to grant accelerated assessment to a handful of new dug candidates that will soon be filed for approval.
Bristol Myers Squibb's marketing application for liso-cel is in the final stages of the review process at the European Medicines Agency. The agency’s drug evaluation committee, the CHMP, adopted in mid-April the list of concerns it has with the application.