Insmed has announced that it anticipates discussions with the EMA by the end of 2013 regarding Arikace inhaled liposomal amikacin for the treatment of nontuberculous mycobacterial (NTM) lung disease and that it has already initiated the Scientific Advice Working Party (SAWP) process. The company says that it is also looking to take advantage of a "globally … [Read more...] about Insmed provides update on Arikace for NTM
Medical
Nephron recalls albuterol inhalation solution
Nephron Pharmaceuticals has announced a voluntary recall of ten lots of albuterol inhalation solution "as a precautionary measure, due to results from . . . internal monitoring processes." The company says that it has not received reports of reportable adverse events for the 0.083% solution and that the lots met Nephron's quality specifications when … [Read more...] about Nephron recalls albuterol inhalation solution
Positive results in artificial pancreas plus inhaled insulin study
Diabetes research organization JDRF, along with Sansum Diabetes Research Institute, and the College of Engineering at University of California, Santa Barbara (UCSB) have announced positive results from a trial of an artificial pancreas used in conjunction with inhaled insulin taken at mealtimes. In 2010, MannKind Corporation announced that it would provide Afrezza … [Read more...] about Positive results in artificial pancreas plus inhaled insulin study
Avanir publishes data on intranasal sumatriptan
Avanir Pharmaceuticals has published results of a pharmacokinetic study of its AVP-825 intranasal sumatriptan powder for the treatment of acute migraine. Avanir licensed AVP-825 from OptiNose in July 2013, and the powder is delivered using the OptiNose breath-activated intranasal device. The study, published in Headache, compared AVP-825 to liquid nasal spray, oral … [Read more...] about Avanir publishes data on intranasal sumatriptan
Mundipharma launches Flutiform trial for COPD
A Phase 3 trial of Flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of COPD has been initiated, according Mundipharma. The 52-week randomized, double-blind EFFECT study compare Flutiform 250/10 μg and Flutiform 125/5 μg with formoterol 12 μg. Flutiform is approved in Europe for the treatment of asthma; it is not approved for the treatment of … [Read more...] about Mundipharma launches Flutiform trial for COPD
BI presents new data on olodaterol and tiotropium at ERS
Boehringer Ingelheim has presented new data from several Phase 3 studies of olodaterol for the treatment of COPD and from the TIOSPIR tiotropium Respimat study at the European Respiratory Society (ERS) Annual Congress 2013. Data from the olodaterol studies shows that two tested doses of the drug delivered by the Respimat inhaler improved lung function in COPD … [Read more...] about BI presents new data on olodaterol and tiotropium at ERS
Positive Phase 2b results for Theravance investigational LAMA
Theravance has announced that a dose-ranging 7-day Phase 2b study of TD‑4208 inhalation solution, an investigational long-acting muscarinic antagonist (LAMA) for the treatment of COPD, met its primary endpoints for all six doses. TD-4208 showed a statistically significant difference compared to placebo from baseline in trough FEV1 for doses ranging from 22 µg to 700 … [Read more...] about Positive Phase 2b results for Theravance investigational LAMA
Civitas initiates Phase 2B study of CVT-301 inhaled levodopa
Civitas Therapeutics has initiated a 28-day Phase 2b efficacy and safety study of CVT-301 inhaled levodopa for the treatment of intermittent motor fluctuations in Parkinson's patients, the company said. The study is partially funded by a $1 million grant from the Michael J. Fox Foundation for Parkinson's Research. Civitas announced positive results from a Phase 2a … [Read more...] about Civitas initiates Phase 2B study of CVT-301 inhaled levodopa
Study finds tiotropium Respimat safety comparable to tiotropium HandiHaler safety
A study appearing online first in the New England Journal of Medicine finds that "Tiotropium Respimat at a dose of 5 μg or 2.5 μg had a safety profile and exacerbation efficacy similar to those of tiotropium HandiHaler at a dose of 18 μg in patients with COPD." According to the authors, the TIOSPIR randomized, double-blind, parallel-group trial of more than 17,000 … [Read more...] about Study finds tiotropium Respimat safety comparable to tiotropium HandiHaler safety
Trinity College and Woolcock Institute get grant for collaboration
The Respiratory Technology Team of the Woolcock Institute for Medical Research (WIMR) has announced that a $12,000 International Research Collaboration Award from the University of Sydney will fund a collaboration between the team and Carsten Ehrhardt of Trinity College Dublin. Ehrhardt will perform research on drug absorption of inhaled drugs at WIMR during a … [Read more...] about Trinity College and Woolcock Institute get grant for collaboration