FLIXABI®, Biogen’s Infliximab Biosimilar Referencing Remicade®, Approved in the European Union
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Biogen's (BIIB) Aducanumab Accepted into EMA PRIME Program
June 1, 2016 12:09 PM EDTBiogen (Nasdaq: BIIB) announced that aducanumab, its investigational treatment for early Alzheimers disease (AD), was accepted into the European Medicines Agencys (EMA) PRIority MEdicines (PRIME) program. PRIME aims to bring treatments to patients faster by enhancing the EMAs support for the development of investigational medicines for diseases without available treatment or in need of better treatment options.
Alzheimers disease is a debilitating condition affecting a growing number of patients and their loved ones, and there is an urgent need for new effective treatment for this disease, said Alfred Sandrock, M.D.,... More
Biogen (BIIB) Announces Receipt of Positive CHMP Opinion for TYSABRI in RRMS Patients
May 31, 2016 7:31 AM EDTThe Committee of Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a variation to the marketing authorization of TYSABRI® (natalizumab), Biogen (NASDAQ: BIIB) announced today. The CHMP recommends the approval of TYSABRI for use as a disease modifying therapy (DMT) for relapsing-remitting multiple sclerosis (RRMS)... More
