EU Accelerated Assessment Tracker 2018: Rejection Rates Remain High
The European Medicines Agency will fast-track Shionogi’s new antibiotic, , through regulatory review when the company files for approval but there’s no special treatment for Roche’s new tissue agnostic oncologic, . More than half the accelerated assessment requests made in 2018 to the EMA failed to make the grade.
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Accelerated assessment requests at the European Medicines Agency.
A decision to yoke together two indications in one EU accelerated assessment filing for the anticancer has backfired on Roche and left the product at even more of a disadvantage compared with Bayer’s Vitrakvi in the tumor-agnostic setting.
New medicines under evaluation at the European Medicines Agency. This article was updated on March 1.