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News Breaks
January 9, 2014
05:08 EDTGSKGSK gains accelerated FDA approval for combination use of Mekinist, Tafinlar
GlaxoSmithKline announced that the FDA has approved Mekinist for use in combination with Tafinlar for the treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved test. Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma. The approval of the combination is based on the demonstration of response rate and median duration of response in a Phase I/II study. Improvement in disease-related symptoms or overall survival has not been demonstrated for Mekinist in combination with Tafinlar. The combination was approved through the FDA's Accelerated Approval programme and reviewed under a Priority Review designation. This accelerated approval is contingent on the results of the ongoing Phase III trial, which is designed to evaluate the clinical benefit of the combination in this patient population.
News For GSK From The Last 14 Days
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December 18, 2014
09:21 EDTGSKOn The Fly: Pre-market Movers
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07:15 EDTGSKAgenus reports GSK ZOE-50 Phase 3 study met primary endpoint
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December 9, 2014
10:23 EDTGSKOn The Fly: Analyst Downgrade Summary
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09:10 EDTGSKARIAD takeover rumors rekindled, Independent says
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07:44 EDTGSKAmerican Association for Cancer Research to hold a symposium
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05:37 EDTGSKGlaxoSmithKline downgraded to Underperform from Neutral at BofA/Merrill
BofA/Merrill downgraded GlaxoSmithKline to Underperform citing a lack of pipeline catalysts and its belief the European pharma sector is close to fair value.
December 8, 2014
13:32 EDTGSKEpizyme announces results for PRMT5 inhibitor
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December 5, 2014
06:04 EDTGSKGSK won't pursue divestment of certain brands in established products portfolio
As announced at the company’s Q2 results in July, GSK started a process to consider the divestment of certain North American and European brands in its Established Products Portfolio.The company has evaluated all bids received and has concluded, consistent with its key criteria of maximizing shareholder value, not to pursue divestment of these products.

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