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MM-398 Receiving The Priority Review Designation By US FDA For New Drug Application And The Acceptance Of Market Authorization Application By EMA In Post-Gemcitabine Metastatic Pancreatic Cancer
2015-07-01 08:52:42| drugdiscoveryonline Home Page
PharmaEngine, Inc. (TWO: 4162) announced that (1) its license partner, Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK), has received the notification from the US Food and Drug Administration (FDA) for the acceptance and the grant of the priority review designation for their New Drug Application (NDA); and (2) its sublicense partner, Baxalta Incorporated, a wholly owned subsidiary of Baxter International Inc. (NYSE: BAX) has received the acceptance of Market Authorization Application (MAA) from the European Medicines Agency (EMA), of MM-398 (irinotecan liposome injection, also known as "nal-IRI,") in the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy
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Category:Biotechnology and Pharmaceuticals