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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The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.