ACTIVATED CHARCOAL/SORBITOL WILL BE NONMONOGRAPH AS POISON TREATMENT in the upcoming final monograph for over-the-counter poison treatment drug products, FDA forewarned the Nonprescription Drag Manufacturers Association in a June 17 letter. The agency noted that although there are "a number" of poison treatment drug products that contain activated charcoal and sorbitol being marketed, FDA has not received any safety and effectiveness data on the combination drug product.
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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.’
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
