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EU Accelerated Assessment Tracker 2018: Rejection Rates Remain High

Executive Summary

The European Medicines Agency will fast-track Shionogi’s new antibiotic, cefiderocol, through regulatory review when the company files for approval but there’s no special treatment for Roche’s new tissue agnostic oncologic, entrectinib. More than half the accelerated assessment requests made in 2018 to the EMA failed to make the grade.

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