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Baxalta's marketing application for pancreatic cancer candidate tagged for accelerated review in Canada

Jan. 07, 2016 8:03 AM ETShire PLC (SHPG) StockBy: Douglas W. House, SA News Editor
  • Health Canada grants Priority Review status for Baxalta's (BXLT) New Drug Submission for irinotecan liposome injection (nal-IRI) for the treatment patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The review should be completed in the second half of the year.
  • Under a licensing deal with Merrimack Pharmaceuticals (MACK), Baxalta is responsible for the development and commercialization of nal-IRI outside of the U.S. and Taiwan.
  • The FDA cleared nal-IRI, branded as Onivyde, in October 2015.
  • Previously: Baxter and Merrimack collaborate on cancer drug (Sept. 24, 2014)

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