CHICAGO - The Phase III results for Bristol-Myers Squibb's ipilimumab represent a breakthrough in melanoma, stole the show at the 2010 American Society of Clinical Oncology annual meeting and are generally expected to presage the first approval of a CTLA-4 inhibitor and the first approval in the disease for more than a decade. But the unexpectedly lackluster performance of an experimental vaccine used with the trial drug and as a control has created some interesting clinical and regulatory plot twists
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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.’
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.
