Biogen Idec, Inc. (Massachusetts) (BIIB) Release: US and EU Regulatory Authorities Accept PLEGRIDY (peginterferon beta-1a) Marketing Applications for Review
7/19/2013 10:05:57 AM
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WESTON, Mass.--(BUSINESS WIRE)--Today Biogen Idec (NASDAQ: BIIB) announced that U.S. and EU regulatory authorities have accepted the marketing applications for the review of PLEGRIDY™ (peginterferon beta-1a), the company’s pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (MS). The U.S. Food and Drug Administration (FDA) has accepted Biogen Idec’s Biologics License Application (BLA) for marketing approval of PLEGRIDY in the United States and granted the company a standard review timeline. The Marketing Authorisation Application (MAA) of PLEGRIDY for review in the European Union was also validated by the European Medicines Agency.
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