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Merck & Co Inc initiates rolling submission of U.S. Biologics license application for MK-3475


Monday, 13 Jan 2014 08:30am EST 

Merck & Co Inc:Says it has started a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application for MK-3475, the company's investigational anti-PD-1 immunotherapy, for patients with advanced melanoma who have been previously treated with ipilimumab.Says a rolling submission allows completed portions of the application to be submitted and reviewed by the FDA on an ongoing basis.Says it expects to complete the application in the first half of 2014. 

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24 Oct 2014