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News Breaks
March 18, 2014
17:30 EDTTHRXTheravance says EC lifts suspension of Marketing Authorization for VIBATIV
In a regulatory filing, Theravance said on March 17, Theravance was informed by its partner, Clinigen Group that it had received a notification dated March 13 from the European Commission, EC, that the EC has lifted the Europe-wide suspension of Marketing Authorization and amended the Marketing Authorization for VIBATIV, telavancin, for the treatment of adults with nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by methicillin resistant Staphylococcus aureus, MRSA, when other alternatives are not suitable. Theravance and Clinigen have an exclusive commercialization agreement in the European Union and certain other European countries for VIBATIV.
News For THRX From The Last 14 Days
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July 24, 2014
10:03 EDTTHRXOn The Fly: Analyst Downgrade Summary
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07:32 EDTTHRXTheravance downgraded at BofA/Merrill
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06:07 EDTTHRXTheravance downgraded to Neutral from Buy at BofA/Merrill
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July 16, 2014
05:38 EDTTHRXGSK, Theravance initiate Phase III IMPACT study
GlaxoSmithKline (GSK) and Theravance (THRX) announced the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the 'closed' triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease, or COPD. IMPACT is the first pivotal phase III study in a programme to evaluate a once-daily closed triple combination treatment of an inhaled corticosteroid, or ICS; a long-acting muscarinic antagonist, or LAMA; and a long-acting beta2-adrenergic agonist, or LABA, in patients with COPD. The IMPACT study will enrol approximately 10,000 patients and assess whether the combination of FF, or fluticasone furoate, an ICS, UMEC, or umeclidinium, a LAMA, and VI, or vilanterol, a LABA, all delivered in GSK's Ellipta inhaler, can reduce the annual rate of moderate and severe exacerbations compared with two approved once daily COPD treatments, Relvar/Breo Ellipta, FF/VI, which is an ICS/LABA combination, and Anoro Ellipta, UMEC/VI, which is a LAMA/LABA combination.

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