FDA's Oncologic Drugs Advisory Committee creates a second obstacle to the approval of Genentech's Avastin in metastatic breast cancer by deciding that existing data do not establish a positive risk-benefit profile for a first-line indication. Genentech's primary obstacle is relying on a surrogate endpoint for full approval, in trying to use progression-free survival as a direct measure of clinical benefit
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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.”
