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Good News, Bad News For Novartis' Oral MS Drug, But REMS Could Help

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Novartis' fingolimod, which could become the first oral treatment for relapsing-remitting multiple sclerosis, recently beat Biogen Idec's Avonex in a head-to-head Phase III trial. The bad news for Novartis is that a handful of severe safety signals, spotted in Phase II, recurred in this most recent trial of the drug

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