News briefs: Genmab/GSK, Gilead and Mylan

24 May 2012

Denmark’s Genmab (OMX: GEN) yesterday received a milestone payment of 20 million Danish kroner ($3.4 million from GlaxoSmithKline to Genmab in connection with the recent filing of the New Drug Application to the Japanese Ministry of Health, Labor and Welfare (MHLW) for Arzerra (ofatumumab) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received prior therapy (The Pharma Letter May 2). The drug was approved in USA in 2009 and in Europe in 2010.

EMA validates Gilead’s cobicistat MAA

US biotech firm Gilead Sciences (Nasdaq: GILD) says that the European Medicines Agency has validated its Marketing Authorization Application for cobicistat as a "pharmacoenhancing" agent that increases blood levels of certain commercially available protease inhibitors such as atazanavir and darunavir in-order to enable a once-daily dosing. The company plans to submit a New Drug Application for cobicistat to the Food and Drug Administration in the third quarter of 2012.

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