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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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September 30, 2014
16:39 EDTGSKCMS discloses drug makers' payments to doctors, WSJ says
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08:01 EDTGSKGE Healthcare to collaborate with GlaxoSmithKline in commercial oncology testing
GE Healthcare (GE) announced an agreement between its affiliate, Clarient Diagnostic Services, and GlaxoSmithKline (GSK). The collaboration aims to improve access to diagnostic testing for cancer patients by establishing a network of clinical laboratories to identify genetic mutations associated with different tumour types. The collaboration will enable GE to develop a broader laboratory and data analytics service that will enable better efficiency in the healthcare market related to oncology precision medicine. This will be made available as a subscription-based service and operated by GE Healthcare. Under terms of the agreement with GSK, GE Healthcare, through its Clarient affiliate, will initially use its clinical laboratory, pathology and genomics expertise, to certify laboratories and generate diagnostic data on metastatic melanoma patients. The first Clarient certified laboratories to initiate this work, are expected to be operational in several countries in early 2015. Laboratory testing will initially focus on more than 70 mutations relevant to melanoma, including BRAF V600E and V600K, with the opportunity to expand testing beyond melanoma into other tumor types, as the network of clinical laboratories develops.
07:30 EDTGSKSachs Associates to hold a conference
14th Annual Biotech in Europe Forum for Global Partnering and Investment to be held in Basel, Switzerland on September 30-October 1.
September 29, 2014
13:47 EDTGSKGlaxoSmithKline reports 45% survival rate of Tafinlar-treated melanoma patients
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07:26 EDTGSKInforma Business Information to hold a conference
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September 25, 2014
05:36 EDTGSKGlaxoSmithKline names Philip Hampton Non-Executive Director
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September 24, 2014
10:18 EDTGSKGlaxoSmithKline set to name RBS' Philip Hampton as next chairman, Sky News says
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September 23, 2014
08:29 EDTGSKGlaxoSmithKline weakness creates buying opportunity, says Argus
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08:07 EDTGSKFDA Pediatric Advisory Committee to hold a meeting
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September 22, 2014
10:15 EDTGSKOn The Fly: Analyst Upgrade Summary
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07:21 EDTGSKEBD Group to hold a conference
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05:27 EDTGSKGlaxoSmithKline upgraded to Buy from Neutral at Goldman
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September 19, 2014
05:58 EDTGSKGlaxoSmithKline to pay GBP 297M fine to Chinese government
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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.

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