Biogen Idec on Wednesday commented on the approval of Novartis' once-daily, oral multiple sclerosis therapy, Gilenya, noting that "the long-term safety profile of Gilenya has yet to be established and there is limited data for it in patients with certain common comorbidities." The drugmaker added that "we agree with the FDA that there is a need for safety monitoring for Gilenya through a comprehensive Risk Evaluation and Mitigation Strategy."
Reference Articles
Biogen Idec makes statement about US FDA approval of Gilenya - (Biogen Idec)
Why Novartis’ approval is bad for Biogen - (Forbes)
Biogen Idec falls 3.4% after issuing statement on MS drug - (Market Intelligence Center)
Biogen gets beat on new MS pill - (Mass High Tech)
Biogen shares hit hard on FDA safety concern over MS drug - (SmarTrend)
Biogen Idec issues statement on Novartis MS drug - (The Boston Globe)
**Published in "First Word"