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Re: surf1944 post# 54

Tuesday, 09/10/2013 2:50:08 PM

Tuesday, September 10, 2013 2:50:08 PM

Post# of 62
7:18AM Theravance halted; FDA Advisory Committee to review ANORO ELLIPTA NDA (THRX) 37.79 : Co announced that NASDAQ halted trading of Theravance common stock this morning, Sep 10, 2013. The Pulmonary-Allergy Drugs Advisory Committee to the FDA meets today to discuss the new molecular entity New Drug Application (NDA) 203975 for umeclidinium bromide and vilanterol dry powder for inhalation (proposed trade name ANORO ELLIPTA), sponsored by Glaxo Group (GSK) (d/b/a GSK) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. UMEC/VI is a combination of two investigational bronchodilator molecules - GSK573719 or umeclidinium bromide, a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA inhaler. UMEC/VI is in development under the LABA collaboration agreement between Glaxo Group and Theravance.

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