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Janssen's New Drug Submission for Daratumumab for Treatment of Multiple Myeloma Accepted for Review by ...

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(Source: Johnson & Johnson) 7a0aabb9-0888-4668-8358-93cee0e0424d.pdf November 18, 2015 Janssen's New Drug Submission for Daratumumab for Treatment of Multiple Myeloma Accepted for Review by Health Canada TORONTO, ON, November 18, 2015 - Janssen Inc. announced today that Health Canada has accepted for review the New Drug Submission (NDS) for daratumumab as a treatment for patients with multiple myeloma. Health Canada will review the submission with advance consideration under the Ministry's Notice of Compliance with Conditions Policy (NOC/c) based on data from the Phase 2 MMY2002 (SIRIUS) monotherapy study. Daratumumab is a new class of therapy - a human anti-CD38 monoclonal antibody. It...

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