PharmaEngine's Cancer Drug Granted Priority Review by the FDA

PharmaEngine of Taiwan reported its pancreatic cancer drug, MM-398, was granted priority review for its US NDA, reducing review time from ten months to six. The filing was made by Merrimack Pharma, PharmaEngine's US licensee. Its European partner, Baxalta, a subsidiary of Baxter, said the filing for approval of MM-398 was accepted by the EMA, triggering an $11 million payment to PharmaEngine. MM-398 (irinotecan liposome injection (nal-IRI)) is indicated for cancer of the pancreas in patients who have failed a gemcitabine treatment. In Taiwan, PharmaEngine's filing for approval of the drug was accepted earlier this month. More details.... Stock Symbols: (TWO: 4162) (NSDQ: MACK) (NYSE: BAX) Share this with colleagues: // //