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Phase 3 programme for revefenacin in COPD starts
14 September 2015 | By Victoria White
The Phase 3 programme includes two replicate three-month efficacy studies and a single 12-month safety study...
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Results from the SUMMIT COPD CV survival study announced
9 September 2015 | By Victoria White
For the primary endpoint of the study, the risk of dying on Relvar/Breo Ellipta 100/25mcg was 12.2% lower than on placebo over the study period, which was not statistically significant...
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GSK and Theravance announce initiation of phase III programme with fixed dose triple combination treatment FF/UMEC/VI in patients with COPD
16 July 2014 | By GlaxoSmithKline
GlaxoSmithKline plc and Theravance, Inc. 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...
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Anoro® Ellipta® (umeclidinium/vilanterol) gains approval in Japan for the treatment of COPD
4 July 2014 | By GlaxoSmithKline
GlaxoSmithKline plc and Theravance, Inc. announced that the Japanese Ministry of Health, Labour and Welfare has approved Anoro® Ellipta® (umeclidinium/vilanterol) for the relief of various symptoms due to airway obstruction with chronic obstructive pulmonary diseases...
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GSK and Theravance announce submission to US regulatory authorities for fluticasone furoate/vilanterol in asthma
1 July 2014 | By GlaxoSmithKline
GlaxoSmithKline plc and Theravance, Inc. announced the submission of a supplemental New Drug Application to the US Food and Drug Administration for a fixed dose combination of the inhaled corticosteroid, fluticasone furoate and the long-acting beta2 agonist, vilanterol...
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GSK and Theravance announce positive data from two studies evaluating the efficacy and safety of Incruse™ Ellipta® when added to Relvar®/Breo® Ellipta® in patients with COPD
11 June 2014 | By GlaxoSmithKline
GlaxoSmithKline plc and Theravance, Inc. announced positive results from two phase III studies, which showed that patients with chronic obstructive pulmonary disease who received the anticholinergic, Incruse™ Ellipta®...
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GSK and Theravance announce positive results from studies comparing ANORO™ ELLIPTA™ with SERETIDE® DISKUS® and ADVAIR® DISKUS®
14 March 2014 | By GlaxoSmithKline
GlaxoSmithKline plc and Theravance, Inc. announced positive results from three phase III studies...
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Anoro® (umeclidinium / vilanterol) receives positive opinion from the CHMP in Europe for the treatment of COPD
20 February 2014 | By GlaxoSmithKline
GlaxoSmithKline plc and Theravance, Inc. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorisation for umeclidinium/vilanterol under the proposed brand name Anoro®...
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RELVAR® ELLIPTA® receives European marketing authorisation for the treatment of asthma and COPD
18 November 2013 | By GlaxoSmithKline
RELVAR® ELLIPTA® is now licensed across 31 European countries...
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FDA Advisory Committee recommends approval in US of umeclidinium/vilanterol for the treatment of COPD
10 September 2013 | By GlaxoSmithKline
GSK and Theravance, Inc. announced that the PADAC to the US FDA voted 11 yes to 2 no that the efficacy and safety data provide substantial evidence to support approval of umeclidinium/vilanterol...
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BREO™ ELLIPTA™ gains US approval for the treatment of COPD
10 May 2013 | By GlaxoSmithKline
GlaxoSmithKline and Theravance announced that the US FDA has approved BREO™ ELLIPTA™...
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GSK and Theravance announce regulatory submission for ANORO™ ELLIPTA™ in Japan
22 April 2013 | By GlaxoSmithKline
Submission of a regulatory application to the Japanese MHLW...
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GSK and Theravance announce FDA acceptance of NDA submission in the US for ANORO ELLIPTATM for COPD
19 February 2013 | By GlaxoSmithKline
The NDA for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI has been accepted...
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GSK and Theravance announce regulatory submission for ANORO™ (UMEC/VI) in Europe
9 January 2013 | By GlaxoSmithKline
GSK and Theravance announced the submission of a regulatory application...
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GSK and Theravance announce regulatory submission for UMEC/VI (LAMA/LABA) in the US
18 December 2012 | By GlaxoSmithKline
ANORO ELLIPTA™ proposed proprietary name for UMEC/VI...
