Plenty Of Action On EU Accelerated Assessment Front
A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.
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Novartis is trying its luck with capmatinib on the accelerated assessment front at the European Medicines Agency. Gilead and Astellas/Seagen have secured fast-track review for their respective potential new products while Sesen Bio and Amryt Pharma are dealing with rejection.
One out of seven requests for the accelerated assessment of planned EU marketing authorization applications is known to have been granted this year to date.
There is one orphan drug among the five new marketing authorization applications that the European Medicines Agency has under review. All five drugs will be reviewed under standard review timelines.