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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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September 17, 2014
14:57 EDTGSKProsensa announces commencement of re-dosing of drisapersen
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07:39 EDTGSKMorningstar to hold a conference
Management Behind the Moat Conference to be held in Chicago on September 17-18.
September 16, 2014
07:33 EDTGSKMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
07:31 EDTGSKEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
September 15, 2014
16:10 EDTGSKFive Prime announces option exercise by GlaxoSmithKline to obtain license
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07:27 EDTGSKIBC Life Sciences to hold a conference
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September 10, 2014
09:58 EDTGSKGlaxoSmithKline has a conference call hosted by JPMorgan
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September 9, 2014
06:25 EDTGSKDocuments show DOJ probed GSK China unit in 2012, Reuters says
Internal documents revealed that a U.S. anti-bribery investigation into GlaxoSmithKline (GSK) touched on the firm's Chinese consumer healthcare division two years ago, which infers that the company's compliance issues in the country could be broader than initially discovered, according to Reuters, citing the documents. Reference Link
September 8, 2014
08:48 EDTGSKGilead announces AMBITION study results in collaboration with Glaxo
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September 7, 2014
13:57 EDTGSKGlaxoSmithKline Ebola vaccine works in tests on monkeys, Bloomberg says
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