How Low Can Gilenia Go? Panel Wants Reduced-Dose Phase IV Trial
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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A new pilot aims to take Brazil closer to ‘digital transformation.’
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The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.