Genzyme Fabrazyme
FDA indicates "there is no need for a December advisory committee review" of the agalsidase beta BLA, Genzyme announces. The company said that it had expected a review by the Endocrinologic and Metabolic Drugs Advisory Committee on December 7-8. Genzyme expects FDA action on the application by Jan. 13
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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.’
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.