Theravance Inc (THRX.O) Key Developments | Reuters.com
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Theravance Inc (THRX.O)

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Latest Key Developments (Source: Significant Developments)

GlaxoSmithKline says lung drug meets late-stage study goals
Monday, 20 Jun 2016 02:02am EDT 

Glaxosmithkline Plc : Fulfil study results closed triple eu . Fulfil study shows superiority of closed triple combination therapy ff/umec/vi versus symbicort turbohaler . Data supports regulatory submission by gsk in europe by end of 2016 . Positive top-line results from phase iii study of fluticasone furoate/umeclidinium/vilanterol . Study met its two co-primary endpoints .Study demonstrated statistically significant improvements in lung function and health- related quality of life.  Full Article

Glaxosmithkline and Innoviva report positive headline results in Salford Lung study
Tuesday, 24 May 2016 05:54am EDT 

Glaxosmithkline Plc : Co and Innoviva announced positive headline results from innovative salford lung study in chronic obstructive pulmonary disease . Study showed that relvar ® ellipta ® 100/25mcg achieved a superior reduction in exacerbations versus usual care, in patients with copd . Analyses remain ongoing and will be subject of future publications and presentations . Second salford lung study is currently being conducted in asthma patients, with results expected in 2017 .For primary effectiveness analysis, in patients treated there was statistically significant reduction in rate of moderate or severe exacerbations.  Full Article

Theravance Inc declares cash dividend
Wednesday, 29 Jul 2015 04:05pm EDT 

Theravance Inc:Declared $0.25 per share cash dividend to be paid on Sept. 30, to stockholders of record as of close of business on Sept. 10.  Full Article

Glaxosmithkline plc and Theravance announces FDA approval of BREO ELLIPTA for treatment of adults with asthma in the US
Thursday, 30 Apr 2015 03:17pm EDT 

Glaxosmithkline plc and Theravance:Says that the US Food and Drug Administration (FDA) has approved BREO ELLIPTA (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma in patients aged 18 years and older.Breo Ellipta is not indicated for the relief of acute bronchospasm.Breo is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate (FF) and the long-acting beta2-agonist (LABA) vilanterol (VI).Says two strengths, 100/25mcg and 200/25mcg, have been approved in the US for use in asthma, administered once-daily using the Ellipta dry powder inhaler.FDA issued a complete response letter related to the proposed use of Breo Ellipta in patients aged 12-17 stating that the data submitted do not show adequate risk-benefit to support the approval in these patients.FDA stated that additional data would be required to further demonstrate the safety and efficacy in this population.  Full Article

Theravance Inc announces cash dividend
Monday, 23 Feb 2015 04:05pm EST 

Theravance Inc:Declares a $0.25 per share cash dividend to be paid on March 31 to stockholders of record as of the close of business on March 12.  Full Article

GlaxosmithKline Plc and Theravance Inc announce start of Phase III lung function study with 'closed' triple combination treatment FF/UMEC/VI for COPD
Monday, 9 Feb 2015 05:12am EST 

GlaxosmithKline Plc and Theravance Inc:Says start of second global phase III study.To evaluate effects of investigational once-daily closed triple combination of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with chronic obstructive pulmonary disease (COPD).Secondary objectives include investigating effect on rate of exacerbations with FF/UMEC/VI compared with budesonide/formoterol, and the safety profile of FF/UMEC/VI compared with budesonide/formoterol.Adverse events of particular interest include pneumonia and cardiovascular risk. Patient perspectives of efficacy and physical activity will also be evaluated versus budesonide/formoterol.First, larger study in phase III programme, known as IMPACT, started in July 2014.To assess whether FF/UMEC/VI can reduce rate of moderate and severe exacerbations compared with two approved once-daily COPD treatments, Relvar/Breo Ellipta, an ICS/LABA combination, and Anoro Ellipta, LAMA/LABA combination.  Full Article

Theravance Inc announces data published on Anoro Ellipta demonstrate improved lung function compared to Tiotropium
Friday, 17 Oct 2014 05:05am EDT 

Theravance Inc:Says it has published positive results from third lung function study comparing efficacy & safety of Anoro Ellipta (umeclidinium /vilanterol, UMEC/VI), combination long-acting muscarinic antagonist/ long-acting beta2-adrenergic agonist, with LAMA tiotropium, administered in HandiHaler inhaler.Says in this study UMEC/VI 62.5/25 mcg showed a statistically significant improvement of 112mL compared with tiotropium 18mcg for the primary endpoint measurement of lung function using trough forced expiratory volume in one second (FEV1) at the end of the treatment period (day 169).Says for the secondary endpoint measurement of lung function using weighted mean FEV1 0 - 6 hour, at the end of the treatment period (day 168) UMEC/VI 62.5/25mcg showed a statistically significant improvement of 105mL, (95% confidence interval (CI) 71, 140, p < 0.001) compared to tiotropium 18 mcg.Says this study was a 24-week, blinded, parallel group, multicenter study to assess the efficacy and safety of UMEC/VI 62.5/25mcg inhalation powder administered once-daily in the dry powder inhaler, Ellipta, compared to tiotropium 18mcg administered once-daily in the HandiHaler inhaler.  Full Article

Theravance Inc appoints Eric d'Esparbes as Senior Vice President and Chief Financial Officer
Thursday, 9 Oct 2014 04:05pm EDT 

Theravance Inc:Announced the appointment of Eric d'Esparbes as Senior Vice President and Chief Financial Officer.  Full Article

Theravance Inc declares dividend for third quarter
Wednesday, 6 Aug 2014 04:08pm EDT 

Theravance Inc:Declares $0.25 per share dividend for third quarter of 2014.Dividend will be paid on Sept. 18, 2014 to all stockholders of record as of close of business on Aug. 28, 2014.  Full Article

Theravance Inc appoints Michael W. Aguiar as president and chief executive officer
Wednesday, 6 Aug 2014 04:05pm EDT 

Theravance Inc:Appoints Michael W. Aguiar as President and Chief Executive Officer of the company effective Aug. 15, 2014 and as a member of the Board of Directors effective immediately.  Full Article