How Low Can Gilenia Go? Panel Wants Reduced-Dose Phase IV Trial
• By The Pink Sheet
FDA should approve Novartis' Gilenia (fingolimod), an oral tablet intended to treat relapsing remitting multiple sclerosis, but should require the company to test a lower dose of the medication in a post-market clinical trial due to the product's many risks, a mostly united advisory panel said June 10
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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