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...
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 UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.
Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.
