EU Accelerated Assessment Tracker: Nine Definites So Far From 24 Requests In 2018
In 2018, the European Medicines Agency considered 24 requests from drug companies for fast-track review of their planned marketing authorization applications. The agency has granted at least nine requests, eleven have been rejected and the results of four have yet to be disclosed.
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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.
Four orphan drugs, Roche’s tissue agnostic cancer treatment entrectinib, and a single-dose oral vaccine for cholera are among the raft of new products that the European Medicines Agency has started to review for potential approval across the EU.
The European Medicines Agency is this week considering applications from two companies seeking the coveted accelerated assessment review pathway for their new products.