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News Breaks
March 26, 2014
07:58 EDTGSKGlaxoSmithKline withdraws MAA to EMA for use of Mekinist and Tafinlar in Europe
GlaxoSmithKline announced that it has withdrawn its Marketing Authorisation Application to the European Medicines Agency for the use of Mekinist in combination with the previously approved BRAF inhibitor Tafinlar for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The application for the use of Mekinist as a single agent in the same patient population, submitted simultaneously with the MAA for the combination, is still undergoing review by the EMA. The Committee for Medicinal Products for Human Use of the EMA has indicated that the data provided to date by GSK did not allow the Committee to conclude on a positive benefit-risk balance of the combination. GSK intends to re-submit the MAA for the combined use of Tafinlar and Mekinist when additional data from the ongoing Phase III programme become available.
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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