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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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October 20, 2014
09:09 EDTGSKEMA encourages applications for orphan designation for Ebola treatments
The European Medicines Agency encourages developers of treatments or vaccines against Ebola to apply for orphan designation. Applications for orphan designation of Ebola medicines will be treated as a priority and EMA has committed to fast-tracking their evaluation, the regulator announced. Drug companies that are working on experimental Ebola vaccines and treatments include Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX), NewLink Genetics (NLNK) and GlaxoSmithKline (GSK).
07:19 EDTGSKIBC Life Sciences to hold a conference
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October 17, 2014
14:50 EDTGSKBARDA asks labs to ramp up Zmapp production, Reuters says
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11:17 EDTGSKGSK says Ebola vaccine too late for current epidemic, BBC reports
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October 14, 2014
13:09 EDTGSKGlaxoSmithKline seeks binding bids for mature drugs, Reuters reports
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11:23 EDTGSKBIND Therapeutics and The Conference Forum hold a conference
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11:19 EDTGSKNIH says several potential Ebola treatments under development
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10:10 EDTGSKNIH director says supporting BioCryst, Chimerix Ebola treatments
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October 13, 2014
07:12 EDTGSKOligonucleotide Therapeutics Society to hold annual meeting
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October 9, 2014
07:02 EDTGSKIsis Pharmaceuticals receives $18M milestone payment from GlaxoSmithKline
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October 8, 2014
06:11 EDTGSKNovartis says expects three executive committee members to leave
Novartis (NVS) confirmed that following completion of the transactions with GlaxoSmithKline (GSK) and Eli Lilly and Company (LLY) in the coming months, that the three business leaders of the Novartis divisions at the center of the transaction will leave the Executive Committee of Novartis. The expected changes to the ECN are subject to the closing of the transactions announced on April 22 - Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with Eli Lilly for its Animal Health Business to close in the first quarter of 2015. George Gunn, currently Division Head, Novartis Animal Health, will reach his contractual retirement age in July 2015 and will retire from Novartis. Upon closing of the Animal Health transaction with Lilly he will leave the ECN. Brian McNamara, currently Division Head, Novartis OTC, will transition to GSK as Head of Americas and Europe for the consumer health businesses, reporting to the President of GSK Consumer Healthcare, effective at closing of the transaction. Andrin Oswald, currently Division Head, Novartis Vaccines, will be leaving Novartis to pursue other opportunities following closing of the transaction with GSK.

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