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News Breaks
January 30, 2013
11:56 EDTGSKGlaxoSmithKline says Guardian wrong to suggest Avandia safety data concealed
GlaxoSmithKline, in response to a news article published this morning in The Guardian on U.K. legal proceedings related to the type 2 diabetes medicine Avandia, said: "We have every sympathy for people with health complications associated with diabetes and those who care for them. However, respecting the UK court process, we are unable to comment on ongoing legal cases. We continue to believe that the company acted appropriately and responsibly in its management of Avandia. Specifically, it is wrong to suggest that we hid or concealed safety data relating to Avandia. We made Avandia clinical trial results available on our website and shared these with regulators. With respect to Avandia, the settlement reached in 2012 following a US Department of Justice investigation related solely to the inadvertent omissions in certain Food and Drug Administration regulatory reports of information regarding the initiation and status of certain studies. The Department of Justice has expressly acknowledged that the information had been provided by GSK to the FDA in other forms. The FDA has also stated that the omissions did not impact the agency’s evaluation of the safety data related to Avandia. We continue to stand behind the safety and efficacy profile of Avandia in the treatment of type 2 diabetes when used appropriately. Nevertheless, we fully accept regulators’ decisions to restrict its use and have worked to make sure health professionals and patients understand this latest advice and guidance." In its report, The Guardian said "GlaxoSmithKline has admitted concealing data about the damaging side-effects of the drug...But, despite this, GSK is not prepared to settle claims in the UK without a court fight." The Guardian's health editor, Sarah Boseley, also stated the history of U.K. drug litigation suggests that "families might not easily get compensation." Shares of GlaxoSmithKline trading in New York were up 0.24% to $45.68 near noon.
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.
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.

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