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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The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.