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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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May 3, 2015
18:11 EDTGSKSiemens investigated by Chinese regulator last year, Reuters says
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May 1, 2015
07:43 EDTGSKExpensive drugs drove over 25% of 2013 Medicare drug spending, WSJ says
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April 30, 2015
16:59 EDTGSKGlaxoSmithKline, Theravance announce FDA approval of Breo Ellipta
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15:20 EDTGSKGlaxo says FDA issued CRL on use of Breo Ellipta in patients aged 12-17
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15:17 EDTGSKGlaxoSmithKline says FDA approves BREO ELLIPTA for adults with asthma
GlaxoSmithKline (GSK) and Theravance (THRX) announced that the FDA has approved BREO ELLIPTA for the once-daily treatment of asthma in patients aged 18 years and older. Breo Ellipta is not indicated for the relief of acute bronchospasm. Breo is a fixed-dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist vilanterol. Two strengths, 100/25mcg and 200/25mcg, have been approved in the US for use in asthma, administered once-daily using the Ellipta dry powder inhaler.
07:21 EDTGSKFDA PDUFA Date for Theravance BREO ELLIPTA is April 30, 2015
April 27, 2015
10:04 EDTGSKHigh option volume stocks
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08:46 EDTGSKAgenus data positive, says JMP Securities
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08:41 EDTGSKTelegraph discusses potential takeover of GSK by Pfizer
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06:19 EDTGSKPharmceutical companies buy drugs and raises prices, WSJ reports
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April 24, 2015
07:11 EDTGSKAgenus: GSK's RTS,S vaccine showed statistically significant results in study
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April 20, 2015
07:20 EDTGSKAmerican Association for Cancer Research to hold annual meeting
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07:01 EDTGSKPernix Therapeutics obtains six months U.S. pediatric exclusivity for Treximet
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