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News Breaks
December 18, 2012
07:20 EDTGSK, THRXGlaxoSmithKline, Theravance announce U.S. regulatory submission for UMEC/VI
GlaxoSmithKline (GSK) and Theravance (THRX) announced the submission of a regulatory application in the US for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease, or COPD. UMEC/VI is a combination of two investigational bronchodilator molecules -- GSK573719 or umeclidinium bromide, or UMEC, a long-acting muscarinic antagonist, or LAMA, and vilanterol, a long-acting beta2 agonist, or LABA, administered using the ELLIPTA inhaler. US Submission: A New Drug Application, or NDA, for UMEC/VI with the proposed proprietary name Anoro Ellipta has been submitted to the FDA, for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.
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08:15 EDTGSK, THRXGlaxoSmithKline 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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