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Wednesday, Jan 16
Biogen Idec (BIIB -0.2%) and Elan (ELN -0.5%) submit applications to the FDA and EMA requesting...
Biogen Idec (BIIB -0.2%) and Elan (ELN -0.5%) submit applications to the FDA and EMA requesting labeling updates to Tysabri to expand the indication to include first-line use for people living with relapsing forms of multiple sclerosis who have tested negative for antibodies to the JC virus. If approved, it will allow all anti-JCV antibody negative patients to consider the drug early in the course of treatment, regardless of the level of disease activity or prior treatment history.