A 72-patient study of Interneuron's Redux (dexfenfluramine) assessing cognitive function provides a "reassuring lack of evidence of neurotoxicity," FDA Medical Officer Leo Lutwak, MD/PhD, told the Endocrinologic & Metabolic Drugs Advisory Committee Nov. 16.
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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.’
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
