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News Breaks | | | | January 30, 2013 | | 11:56 EDT |  | GSK | GlaxoSmithKline 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. | |
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News For GSK From The Last 14 Days Check below for free stories on GSK the last two weeks. |
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| May 22, 2013 | | 08:25 EDT | | GSK | GlaxoSmithKline awarded up to $200M by U.S. to develop new antibiotics
 Subscribe for More Information | | | May 21, 2013 | | 07:44 EDT |  | GSK | Sachs Associates to host a forum
Subscribe for More Information | | | 07:07 EDT |  | GSK | Theravance pullback on Elan bid a buying opportunity, says Piper Jaffray
Subscribe for More Information | | | May 14, 2013 | | 07:24 EDT | | GSK | EBD Group to host a conference
BioTrinity 2013 is being held in Newbury, England on May 14-16. | | | May 13, 2013 | | 16:25 EDT |  | GSK | On The Fly: Closing Wrap
Stocks on Wall Street were little changed from their opening levels as investors weighed the potential end of the Fed's quantitative easing program against a better than expected report on retail sales. The Wall Street Journal's Jon Hilsenrath suggested in a report over the weekend that the Federal Reserve has mapped a QE exit strategy. The report paired with the retail sales data left the market lacking conviction in either direction today, as the averages spent the majority of the session range-bound near the flatline. ECONOMIC EVENTS: In the U.S., retail sales rose 0.1% in April, which beat expectations for a 0.3% decline. Retail sales excluding autos, gas, and building materials rose 0.6%, which was also better than expected. Business inventories were flat in March, versus expectations for a 0.3% gain. In Asia, Chinese factory output grew 9.3% annually in April, which was up from 8.9% in March but still missed expectations for a 9.5% growth rate. COMPANY NEWS: The Supreme Court ruled unanimously that Monsanto's (MON) patented genetically altered soybeans are protected and that farmers cannot use them to create new seeds without paying the company... Dell's (DELL) special committee publicly asked for more information from Carl Icahn and Southeastern Asset Management about their proposed leveraged recapitalization. This request follows television interviews by Icahn last Friday in which he discussed his Dell proposal, as well as a weekend report in Barron's saying the Icahn and Southeastern plan could be a better deal for shareholders. MAJOR MOVERS: Among the notable gainers was Theravance (THRX), up $6.26, or 17.92%, to $41.20 after Elan Corporation (ELN) bought a stake in the potential future royalty payments from four respiratory programs partnered with GlaxoSmithKline (GSK) in exchange for $1B in cash. Also higher was Tesla (TSLA), which rose $11.04, or 14.38%, to $87.80 in its third straight double-digit percentage gain following a better-than-expected earnings report last week. Among the noteworthy losers was Barnes & Noble (BKS), down $2.21, or 9.48%, to $21.10 after the blog InsiderMonkey disputed a previous report about Microsoft's (MSFT) interest in the bookseller's NOOK assets. Also lower was JoS. A. Bank (JOSB), down $3.31, or 7.16%, to $42.90 after the company's first quarter earnings view came in below expectations. INDICES: The Dow was down 26.81, or 0.18%, to 15,091.68; the Nasdaq was up 2.21, or 0.06%, to 3,438.79; and the S&P 500 was nearly unchanged at 1,633.77. | | | 12:20 EDT | | GSK | On The Fly: Midday Wrap
Subscribe for More Information | | | 05:44 EDT | | GSK | Elan provides additional information on Elan/Theravance agreement
Subscribe for More Information | | | 05:35 EDT | | GSK | Theravance, Elan enter into $1B royalty participation agreement
Subscribe for More Information | | | May 10, 2013 | | 12:42 EDT | | GSK | GlaxoSmithKline, Theravance confirm FDA approval of Breo Ellipta
Subscribe for More Information | | | 11:48 EDT |  | GSK | Drugmakers to face pressure on U.S. prices, Reuters says
Subscribe for More Information | | | | 11:15 EDT | | GSK | FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease
Subscribe for More Information | | | 06:53 EDT | | GSK | GlaxoSmithKline, Merck to discount cancer vaccine in poor nations, NY Times says
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