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.’
The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
