Orphan Drugs Nefecon, Maribavir & Copanlisib Among New EU Filings
US Filings For The Orphan Drugs Are Under Review
Marketing applications for two generic versions of the multiple sclerosis blockbuster, Tecfidera, are also under review by the European Medicines Agency.
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In the first half of 2021, just six requests from companies seeking accelerated assessment of their planned EU marketing authorization applications were granted; 11 were rejected. The outcomes of five decided on in July and August are still unknown.
The European Medicines Agency has added nine new products to its latest list of medicines that are under review for potential EU marketing authorization.
bluebird bio's decision to wind down commercial initiatives for its gene therapy business in Europe is a blow for the sector in the region as a whole.