Biogen's Aducanumab And Three Other Drugs Get First EU PRIME Designations
The European Medicines Agency has announced the names of the first four drugs to be accepted onto its new priority medicines scheme, including Biogen Inc.'s aducanumab for Alzheimer's disease. But the agency also turned down 14 other applications for PRIME eligibility.
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New guidance from the UK covers the recognition of EU approvals, accelerated assessment, rolling reviews, and much else besides.