Irinotecan regulatory update

FDA and EMA accepted for review regulatory applications from Merrimack and Baxter for MM-398 to treat metastatic adenocarcinoma of the pancreas in patients who have been previously treated with gemcitabine-based therapy. FDA granted Priority Review to the NDA, which has an Oct. 24 PDUFA date and was submitted by Merrimack. Baxter submitted the MAA to EMA in early May. Partner PharmaEngine submitted an NDA in Taiwan in May. ...