‘Open & Constructive’: Early Feedback Supports Simultaneous Scientific Advice In Europe
16 Meetings Have Taken Place So Far
A European pilot project that lets drug companies developing innovative products receive scientific advice from two EU member states at the same time is proving its worth during the pandemic.
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Improvements have been made to the second phase of an EU pilot that allows drug sponsors to obtain simultaneous scientific advice from two member states.
Twelve new drugs are now being reviewed for potential EU marketing approval, including Servier’s vorasidenib for IDH-mutant diffuse glioma, which the company says could become the first targeted therapy for the malignant and incurable brain tumor.
Outlook Therapeutics is hoping to secure EU marketing approval for the first ophthalmic formulation of bevacizumab.