Approved nearly six weeks before the March 8 PDUFA date, Erivedge (vismodegib) will be available to treat advanced basal cell cancers in a week or two for about $7,500 a month wholesale, partner Genentech said.
FDA’s approval of the hedgehog inhibitor Erivedge (vismodegib) for patients with advanced basal cell cancer is the first for the drug classand a transformational event for Lexington, Mass., biotech Curis Inc.
The approval, which came more than a month before its priority review PDUFA date, was announced Jan. 30 by Curis and Genentech Inc., a member of the Roche Group,...
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.’
President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.
FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
