Medical

GlaxoSmithKline and Innoviva have announced the initiation of a Phase 3 study of a fluticasone furoate/umeclidinium/vilanterol DPI compared to Relvar/Breo Ellipta for the treatment of asthma. GSK recently filed regulatory submissions for the FF/UMEC/VI DPI for the treatment of COPD in the United States and in the European Union. The Clinical study of Asthma … [Read more...] about GSK initiates Phase 3 study of triple therapy DPI for the treatment of asthma

Aradigm Corporation has announced that top-line results from the Phase 3 ORBIT-3 and ORBIT-4 trials of Pulmaquin inhaled ciprofloxacin for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis bronchiectasis (non-CF BE) demonstrated increase in time to the first exacerbation, the primary endpoint, that was not statistically significant in … [Read more...] about Aradigm announces top line results from Phase 3 trials of Pulmaquin for non-CF bronchiectasis

Results from a study of Adherium's Smartinhaler adherence monitoring system showing a 5-fold reduction in hospitalizations over a one-year period for children with poorly controlled asthma who used the device have been published online by the journal Thorax. The STAAR study also found that adherence among the 38 children who completed the study using the … [Read more...] about Study shows significant reduction in hospitalizations for children using Smartinhaler

Irish science center AMBER (Advanced Materials and BioEngineering Research), located at Trinity College Dublin, has announced that investigator Anne Marie Healy has received a €600,000 grant from the US National Institutes of Health (NIH) for development of a new mucolytic therapy dry powder inhaler. Clinical trials are expected to begin within five years. … [Read more...] about AMBER announces NIH funding for development of DPI

Mucosis has initiated a Phase 1 study of its SynGEM intranasal respiratory syncytial virus (RSV) vaccine, the company said. In January 2016, Mucosis announced that it had received a €3.7 million grant from the Wellcome Trust for Phase 1 and Phase 2a studies. The Phase 1 study will be conducted at Imperial College London and will involve 48 healthy adults. The … [Read more...] about Mucosis initiates Phase 1 trial of its intranasal RSV vaccine

Spyryx Biosciences has presented data from preclinical studies of its SPX-101 inhaled SPLUNC1-derived peptide showing that SPX-101 improves mucus clearance and survival in animal models of cystic fibrosis and demonstrated no toxicity. The data were presented in three posters at the North American Cystic Fibrosis Conference. According to the company, nebulized … [Read more...] about Spyryx Biosciences presents data from preclinical studies of SPX-101

Arch Biopartners has announced that Dr. Ralph Panos of the Cincinnati Veterans Affairs Medical Center (CVAMC) will prepare a protocol for human trials of the company's AB569 inhaled bactericide and will subsequently prepare an application to conduct the trials. The company expects that the application will be submitted to the IRB of the CVAMC by December 2016, … [Read more...] about Arch Biopartners announces preparations for Phase 1 and 2 trials of AB569

Upsher-Smith Laboratories has presented data from a Phase 1 study of its USL261 midazolam nasal spray in children with epilepsy demonstrating that the median Tmax for 1.25 mg, 2.5 mg and 5 mg single doses was ~15 minutes and Cmax was not dose dependent. According to the company, the FDA has granted both fast track and orphan drug designations to USL261 for rescue … [Read more...] about Upsher-Smith reports results from Phase 1 study of midazolam nasal spray in children

Windtree Therapeutics has announced that a lung deposition study in cynomolgus macaques showed that its proprietary aerosol delivery system (ADS) delivered KL4 surfactant uniformly to all regions of the lung. The ADS is being developed to deliver Windtree's Aerosurf inhaled lucinactant, which is in Phase 2 development for the treatment of respiratory distress syndrome … [Read more...] about Windtree Therapeutics announces data from deposition study using its aerosol delivery system

Eurocine Vaccines has started a Phase 1/2 clinical study of its Immunose FLU intranasal quadrivalent influenza vaccine, which uses the company's Endocine adjuvent and inactivated split antigens, the company said. Results should be available in mid-2017. Eurocine Vaccines Chief Scientific Officer Anna-Karin Maltais said, "We are very pleased that our nasal influenza … [Read more...] about Eurocine Vaccines begins Phase 1/2 study of intranasal flu vaccine