Biogen IDEC (NASDAQ: BIIB): Closing price $178.00
Biogen has received a positive opinion from the Committee for Medicinal Products for Human Use in the European Union, recommending a marketing authorization be granted for Tecfidera (dimethyl fumarate) as a first-line oral treatment for adults suffering from relapsing-remitting multiple sclerosis. The Committee, on the basis of quality, safety and efficacy data submitted by Biogen Idec, considers there to be a favorable benefit-to-risk balance for the drug. The recommendation is now referred to the European Commission, which grants marketing authorization for medicines in the European Union. The FDA should make a decision on the marketing application for Tecfidera in the United States in the coming days.
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