Medical

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

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 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

Boehringer Ingelheim has announced new data from the ENERGITO and OTEMTO studies of the Stiolto tiotropium/olodaterol Respimat inhaler for the treatment of COPD. The FDA approved Stiolto Respimat in May 2015; in Europe, where the product is known as Spiolto Respimat, BI announced approval by several countries in July 2015. BI previously announced data from OTEMTO … [Read more...] about BI announces new data from Stiolto/Spiolto Respimat studies

OptiNose has announced positive results from the NAVIGATE I Phase 3 trial of its OPN-375 intranasal fluticasone for the treatment of nasal polyposis demonstrating statistically significant reduction of symptoms and total polyp grade. In June 2015, the company announced positive results from the NAVIGATE II trial. Based on the results from both studies, OptiNose said, … [Read more...] about Additional positive Phase 3 results for OptiNose intranasal fluticasone

Theravance Biopharma and Mylan announced that they have initiated Phase 3 studies for TD-4208 revefenacin inhalation solution for the treatment of COPD. The Phase 3 program includes 2 12-week efficacy studies plus a 12-month safety study and is expected to enroll 2,300 patients. The two companies announced in February 2015 that they would partner on development of the … [Read more...] about Mylan and Theravance Biopharma initiate Phase 3 trials of revefenacin for COPD

AZTherapies announced that it has initiated a Phase 3 study of its ALZT-OP1 DPI for the treatment of early stage Alzheimer's disease. ALZT-OP1 is a dry powder formulation of cromolyn and ibuprofen that is delivered by a proprietary inhaler called Azhaler-D; AZTherapies licensed the technology from Massachusetts General Hospital. The company said that it plans to be … [Read more...] about AZTherapies begins Phase 3 study of inhaled Alzheimers therapy

GSK and Theravance have announced that a study called SUMMIT (Study to Understand Mortality and MorbidITy in COPD ) showed that COPD patients treated with the Breo/Relvar Ellipta fluticasone furoate/vilanterol DPI had lower risk of dying than those treated with placebo, but the difference was not statistically significant. Almost 16,500 COPD patients who had either a … [Read more...] about Breo/Relvar Ellipta study shows reduction in deaths not statistically significant