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News For IPSEY From The Last 14 Days
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September 1, 2014
10:41 EDTIPSEYIpsen announces acceptance of filings for Somatuline for GEP-NETs1 treatment
Ipsen N.A., an affiliate of Ipsen announced that the FDA has accepted and granted priority review of its supplemental New Drug Application, sNDA, for Somatuline Depot 120mg injection in the treatment of gastroenteropancreatic neuroendocrine tumors, GEP-NETs. The FDA designates priority review status to drug candidates that have the potential to offer a significant improvement in treatment compared to currently approved options. A decision is expected in early Q1, 2015. The regulatory submission was supported by the results of the investigational CLARINET Phase III study, which demonstrated the antitumor effect of Somatuline in the treatment of patients with GEP-NETs, and which was recently published in the July 17th issue of The New England Journal of Medicine.
08:52 EDTIPSEYIpsen says FDA accepts Somatuline Depot for priority review
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