CHICAGO - With the positive results of Roche's AVADO study of Avastin in first-line metastatic breast cancer, Roche and Genentech have the value of having a placebo-controlled, double-blind confirmation of bevacizumab's use in that setting. But what the presentation of AVADO at the American Society of Clinical Oncology annual meeting really did was revive debate over the breast cancer approval and raise questions about proper use in that setting
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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.
