Adolor and marketing partner GlaxoSmithKline's post-operative constipation therapy Entereg is the first drug to clear FDA with its highest level of Risk Evaluation and Mitigation Strategy - a required controlled distribution program. Entereg is at least the fifth new drug, and the second new molecular entity, to be approved with a REMS since the new authority granted by the FDA Amendments Act went into effect March 25
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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.’
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
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.
