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News Breaks
November 15, 2012
06:48 EDTGSKGlaxoSmithKline says FDA panel recommends approval of H5N1 flu vaccine
GlaxoSmithKline announced that the U.S. Food and Drug Administrationís Vaccines and Related Biological Products Advisory Committee voted unanimously 14-0 that the safety and immunogenicity data of the H5N1 adjuvanted influenza vaccine candidate supports its licensure for the active immunisation for the prevention of disease in persons 18 years of age and older who are at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine. The VRBPAC provides the FDA with independent expert advice and non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. According to agency regulations, the FDA is scheduled to conclude its review for the vaccine in December 2012. If approved, the vaccine is to be used only according to official guidance from the U.S. Government.
News For GSK From The Last 14 Days
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July 2, 2015
18:37 EDTGSKViiV, Desano enter strategic manufacturing agreement for Tivicay
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June 26, 2015
10:38 EDTGSKCourt revives lawsuit over GlaxoSmithKline Lamictal drug, Bloomberg reports
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June 25, 2015
14:01 EDTGSKGlaxoSmithKline initiated with a Buy at HSBC
Price target GBP 17.
June 24, 2015
13:37 EDTGSKGSK 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 EDTGSKPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.

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