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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 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.
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

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