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April 2, 2014
08:37 EDTKERXKeryx announces EMA validation of MAA for Zerenex
Keryx Biopharmaceuticals announced that the European Medicines Agency, or EMA, has determined that the company's Marketing Authorization Application, or MAA, seeking the approval of Zerenex as a treatment for hyperphosphatemia in patients with chronic kidney disease, CKD, including dialysis- and non-dialysis-dependent CKD, is valid. Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. The EMA's review of the application will follow the centralized marketing authorization procedure. If approved by the EMA, Zerenex will receive marketing authorization in all 27 member states of the European Union, as well as in Norway, Liechtenstein and Iceland.
News For KERX From The Last 14 Days
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May 4, 2015
07:17 EDTKERXKeryx reports Q1 EPS (28c), consensus (30c)
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April 23, 2015
08:08 EDTKERXKeryx appoints John Neylan, MD, as Chief Medical Officer
Keryx Biopharmaceuticals announced the appointment of John Neylan, MD to the newly created position of Chief Medical Officer. In this role, Dr. Neylan will be responsible for oversight of medical affairs, clinical development and pharmacovigilence at Keryx. Dr. Neylan comes to Keryx from Genzyme, where since 2008 he served in the capacity of SVP, Clinical Development, focusing on specialty metabolic diseases.

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