PharmaEngine receives FDA Priority Review, EMA MMA acceptance for MM-398

Monday, June 29, 2015

PharmaEngine has announced that its license partner, Merrimack Pharmaceuticals, has received FDA acceptance and Priority Review designation for their NDA and its sublicense partner, Baxalta, a wholly owned subsidiary of Baxter International, has received Market Authorization Application (MAA) from the 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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