THALIDOMIDE APPROVAL RECOMMENDATION WOULD OVERRULE FDA PRIMARY REVIEWERS, DIVISION DIRECTOR; REVIEW WOULD BE SYMBOL OF NEW FDA THEMES OF PATIENT ACCESS
The FDA advisory committee recommendation to approve Celgene's thalidomide for use in the treatment of systemic erythema nodosum leprosum contrasts with the non-approval recommendations of the primary reviewers and division director.
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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.’
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A new European initiative will help trial sponsors better understand whether digitization and decentralized clinical trials of drugs generate less carbon than traditional methods.
A first-of-its-kind review of clinical trial applications submitted to the UK medicines regulator, the MHRA, shows there is a concentration of research in certain disease areas and identifies opportunities to enhance the representation of specific patient groups.
Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.