Medical

Novartis today has announced that the Phase 3 FLAME study demonstrated that the Utibron Neohaler (Ultibro Breezhaler) indacaterol/glycopyrronium DPI reduced the rate of COPD exacerbations more effectively than the Advair (Seretide) fluticasone/salmeterol DPI over a 52-week period. FLAME involved over 3,360 COPD patients in 43 countries and was designed to demonstrate … [Read more...] about Phase 3 study shows indacaterol/glycopyrronium reduces COPD exacerbations better than Advair

Teva Pharmaceutical Industries has announced top-line results from three Phase 3 clinical studies of its generic fluticasone propionate/salmeterol DPI and a fluticasone propionate monotherapy DPI for the treatment of asthma. The company said that all of the studies met their primary endpoints and that it plans to submit regulatory applications to the FDA for both … [Read more...] about Positive top-line results from several Teva Phase 3 DPI studies

Discovery Laboratories has announced additional data from its Phase 2a trials of Aerosurf aerosolized surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants 29 to 34 week gestational age. that are receiving nasal continuous positive airway pressure (nCPAP). The company said that the data are "encouraging" and demonstrate that Aerosurf … [Read more...] about Discovery Labs announces additional Phase 2a data, says it is ready to advance Aerosurf to Phase 2b

Discovery Laboratories has provided an update on its clinical development program for Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants. In March 2015, the company announced that it was restructuring to focus all its attention on Aerosurf. According to Discovery Labs, enrollment in a Phase 2a expansion … [Read more...] about Discovery Labs provides update on Aerosurf development

GlaxoSmithKline has announced results from the 26-week AUSTRI postmarketing study comparing the safety of Advair Diskus fluticasone propionate/salmeterol DPI to fluticasone propionate monotherapy for the treatment of asthma. According to GSK, the study demonstrated that Advair Diskus was non-inferior to FP at three different dosage strengths for the risk of serious … [Read more...] about GSK announces that Advair Diskus meets primary endpoint in safety study

GlaxoSmithKline has announced data from two studies demonstrating that the Incruse Ellipta umeclidinium DPI produced statistically significant increase in FEV1 at 12 weeks in COPD patients compared to tiotropium and was non-inferior to glycopyrronium. GSK said that data from both 12-week randomized, blinded head-to-head studies will be presented at a future scientific … [Read more...] about GSK announces results from studies of Incruse Ellipta vs tiotropium and glycopyrronium

Sunovion is presenting data from retrospective database analyses in two separate posters at the 2015 American College of Chest Physicians annual meeting that show similar rates of hospital readmission for COPD patients treated with Brovana arformoterol tartrate inhalation solution compared to fluticasone/salmeterol or tiotropium bromide. Rates of 1-month all-cause … [Read more...] about Similar hospital readmission rates for COPD patients using Brovana vs. fluticasone/salmeterol or tiotropium bromide

The first patients have been dosed in a Phase 2a study of Verona Pharma's RPL554 inhaled PDE3/PDE4 inhibitor as an addition to albuterol (salbutamol) and with ipratropium for the treatment of COPD, Verona said. The double-blind, placebo-controlled, six way crossover study will enroll up to 30 patients and will use the new suspension formulation of RPL554. Verona … [Read more...] about Phase 2 trial of Verona’s RPL554 for the treatment of COPD gets underway