|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.
News For GSK From The Last 14 Days
|June 26, 2015|
|10:38 EDT||GSK||Court revives lawsuit over GlaxoSmithKline Lamictal drug, Bloomberg reports|
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|June 25, 2015|
|14:01 EDT||GSK||GlaxoSmithKline initiated with a Buy at HSBC|
Price target GBP 17.
|June 24, 2015|
|13:37 EDT||GSK||GSK says CDC committee votedfor meningococcal group B vaccines|
GlaxoSmithKline (GSK) announced that the U.S. Centers for Disease Control Advisory Committee on Immunization Practices voted for a Category B recommendation for meningococcal group B vaccination, including Bexsero, in individuals aged 16 to 23. Bexsero was approved by the FDA in January for use in individuals aged 10 through 25 years and acquired by GSK in March following the closure of the three-part transaction with Novartis (NVS).
|June 23, 2015|
|07:25 EDT||GSK||Piper Jaffray to hold a summit|
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.
|June 22, 2015|
|07:01 EDT||GSK||Pfizer to acquire Nimenrix, Mencevax from GlaxoSmithKline for $130M|
Pfizer (PFE) announced that it has entered into an agreement with GlaxoSmithKline (GSK) to acquire its quadrivalent meningitis ACWY vaccines, Nimenrix and Mencevax, for a total consideration of approximately $130M. This transaction will add two high-quality and complementary vaccines to Pfizer’s portfolio, allowing the company to reach a broader global population. Nimenrix is a single dose meningococcal ACWY-TT conjugated vaccine designed to protect against Neisseria meningitidis, an uncommon but highly contagious disease that can lead to disability and death. Mencevax is a single-dose meningococcal ACWY unconjugated polysaccharide vaccine used to control outbreaks of meningococcal infection and for travelers to countries where the disease is endemic or highly epidemic. Pfizer does not expect this transaction to have any significant impact on its 2015 financial performance. The transaction is subject to customary closing conditions as well as regulatory approvals in several markets, and is expected to occur in the second half of 2015. Pfizer’s legal advisors for the transaction were Ropes & Gray and Clifford Chance.
|June 18, 2015|
|13:08 EDT||GSK||GlaxoSmithKline management to meet with Piper Jaffray|
Meeting to be held in Minneapolis on June 23 hosted by Piper Jaffray.
|June 16, 2015|
|13:16 EDT||GSK||FDA appoves labeling changes for GSK anti-seizure drug |
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