Agency's newest advisory committee will hold its first meeting July 30-31. The panel was formed to help with FDA reviews of cytokines and other biologicals seeking approval for use in treating cancer. The meeting's agenda has not been released, but reportedly, the committee's first reviews could involve GM-CSF and G-CSF. PLAs for GM-CSF products were filed earlier this year by Immunex and Schering-Plough. Amgen submitted a PLA for G-CSF in December.
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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.’
New members of the CDC’s Advisory Committee on Immunization Practices suggested concerns beyond myocarditis, questioning whether test-negative observational studies are giving an incorrect picture of effectiveness.
The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.
Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”
