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GlaxoSmithKline (GSK) Catches Analysts Off-Guard and Files Melanoma Drug Combo Early in Race to Market



7/10/2013 8:49:55 AM

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GlaxoSmithKline has filed for U.S. approval of a two-drug combination against melanoma earlier than many industry analysts expected, using data from a mid-stage clinical trial. The move highlights a growing belief among drug companies that highly specific cancer drugs can prove their worth after relatively small-scale testing, speeding their path to market. Britain's biggest pharmaceuticals group said on Tuesday it had submitted the combination of dabrafenib and trametinib to the U.S. Food and Drug Administration based on data from a randomised Phase I/II study.

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