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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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April 27, 2015
10:04 EDTGSKHigh option volume stocks
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08:46 EDTGSKAgenus data positive, says JMP Securities
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08:41 EDTGSKTelegraph discusses potential takeover of GSK by Pfizer
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06:19 EDTGSKPharmceutical companies buy drugs and raises prices, WSJ reports
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April 24, 2015
07:11 EDTGSKAgenus: GSK's RTS,S vaccine showed statistically significant results in study
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April 20, 2015
07:20 EDTGSKAmerican Association for Cancer Research to hold annual meeting
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07:01 EDTGSKPernix Therapeutics obtains six months U.S. pediatric exclusivity for Treximet
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April 16, 2015
09:14 EDTGSKAdamis says albuterol HFA product study met clinical FEV1 primary endpoint
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08:15 EDTGSKGlaxoSmithKline and Theravance announce launch of Anoro in Spain
In a regulatory filing, GlaxoSmithKline (GSK) and Theravance (THRX) announced the launch of Anoro in Spain following the approval in Europe in May 2014. Anoro Ellipta is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. Anoro Ellipta is a combination of two bronchodilators, umeclidinium, a long-acting muscarinic antagonist and vilanterol, a long-acting beta2 agonist, in a single dry powder inhaler, the Ellipta. The approved dose of UMEC/VI is 55/22mcg. UMEC/VI has been developed under the 2002 LABA collaboration agreement between Glaxo Group Limited and Theravance.
April 15, 2015
11:53 EDTGSKGlaxoSmithKline initiated with a Sell at Societe Generale

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