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Medical

Discovery Labs announces additional Phase 2a data, says it is ready to advance Aerosurf to Phase 2b

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 Labs provides update on Aerosurf development

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

Acerus changes course on Tefina intranasal testosterone gel, says Endo “de-priotizing” Natesto

Acerus (formerly Trimel) has announced that it will pursue development of its Tefina nasal testosterone for the treatment of hypoactive sexual desire disorder (HSDD) instead of for female orgasmic disorder (FOD). In May 2014, the company announced positive results from a Phase 2 study of Tefina for FOD. The decision to switch course came after meeting with the FDA … [Read more...] about Acerus changes course on Tefina intranasal testosterone gel, says Endo “de-priotizing” Natesto

GSK announces that Advair Diskus meets primary endpoint in safety study

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

GSK announces results from studies of Incruse Ellipta vs tiotropium and glycopyrronium

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

Similar hospital readmission rates for COPD patients using Brovana vs. fluticasone/salmeterol or tiotropium bromide

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

Phase 2 trial of Verona’s RPL554 for the treatment of COPD gets underway

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

Serendex announces positive topline data from Phase 1 study of Molgradex

Serendex Pharmaceuticals has announced that data from a Phase 1 randomized, double blind, placebo controlled single ascending dose/multiple ascending dose trial showed that Molgradex inhaled GM-CSF (molgramostim) was well tolerated at all dose levels. No serious or severe events were reported, and similar numbers of subjects in both the active and control groups … [Read more...] about Serendex announces positive topline data from Phase 1 study of Molgradex

Phase 2 data show effectiveness of Invion’s inhaled nadolol for smoking cessation

A Phase 2 study of Invion's INV102 inhaled nadolol showed that smokers using the therapy were much more likely to stop smoking or significantly reduce the number of cigarettes they smoked than those using a placebo, the company said. The randomized, double blinded, placebo controlled study also showed a significant reduction in biomarkers for the beta arrestin … [Read more...] about Phase 2 data show effectiveness of Invion’s inhaled nadolol for smoking cessation

Verona reports positive data from SAD/MAD trial of RPL554 for COPD

Verona Pharma has announce that data from the third part of single ascending dose (SAD)/multiple ascending dose (MAD) trial of nebulized RPL554 in COPD patients show that the formulation was well tolerated at all doses with no serious adverse events and that patients using RPL554 experienced "pronounced improvement in lung function." Verona reported results from … [Read more...] about Verona reports positive data from SAD/MAD trial of RPL554 for COPD

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