Genetech's Activase: Supplemental PLA submitted March 19 for treatment of acute ischemic stroke within three hours of symptom outset based on results of a Phase III clinical study by the National Institute of Neurological Disorders & Stroke published in December. Activase (alteplase, t-PA) administration resulted in 30% more patients "likely to have minimal or no disability," over four assessment scales. Activase is marked for acute myocardial infarction and pulmonary embolism...
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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.’
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
