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News Breaks
February 7, 2013
10:33 EDTGSKGlaxoSmithKline submits MEK monotherapy, BRAF/MEK combo therapy to EMA
GlaxoSmithKline announced submission of a Marketing Authorization Application to the European Medicines Agency for trametinib, or MEK, as monotherapy and in combination with dabrafenib, or BRAF, for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The EMA’s Committee for Medicinal Products for Human Use has granted GSK’s request for accelerated assessment of this application, the company said. An application that has been granted accelerated assessment will have a maximum review time of 150 days. However, at any time during the assessment CHMP may decide to continue the assessment under the standard centralised procedure assessment timelines of 210 days or GSK may submit a request for a change to a standard assessment procedure.
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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