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Priority Review Status Granted by Health Canada for irinotecan liposome injection (nal-IRI) for New Drug Submission; review expected to be complete in the second half of 2016

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BXLT

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Additional Information

Additional Relevant Details Priority Review allows for expedited review of critical new drugs faster than the standard timeline. Review by Health Canada is expected to be conducted in the second half of 2016. Baxalta is responsible for the development and commercialization of nal-IRI outside of the U.S. and Taiwan under the exclusive licensing agreement with Merrimack Pharmaceuticals, Inc.
http://newsroom.baxa...
Additional Relevant Details The Application was closed and not fully submitted in Canada. 
https://www.cadth.ca...
Additional Relevant Details Drug ownership was acquired by Ipsen on 3/4/17.
http://www.ipsen.com...
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Catalyst Date
Occurred on:
Mar 11, 2017
Occurred Source:
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Related Keywords Priority Review, Health Canada, Metastatic Pancreatic Cancer, Mpac, Nds, Irinotecan Liposome Injection, Nal-iri