Trade Resources Industry Views GSK Have Announced The Submission of a New Drug Application

GSK Have Announced The Submission of a New Drug Application

Genmab and GlaxoSmithKline (GSK) have announced the submission of a new drug application (NDA) for Arzerra (ofatumumab) to the Japanese Ministry of Health, Labor and Welfare (MHLW).

 

Arzerra (ofatumumab) is submitted for the approval to treat chronic lymphocytic leukemia (CLL).

 

Genmab chief executive officer Jan van de Winkel said, "This marks another important achievement in our collaboration with GSK for Arzerra."

 

Genmab is a publicly traded, biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/genmab-gsk-announce-nda-submission-for-arzerra-in-japan-300412
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Genmab, GSK Announce NDA Submission for Arzerra in Japan