Medical

Grifols has announced that its inhaled alpha1-proteinase inhibitor received orphan drug designation from the FDA in April 2012 and that the company will begin a safety study of the drug by the end of the year. Grifols markets intravenous alpha1-proteinase inhibitor, derived from human plasma, as Prolastin-C as a treatment for alpha1-antitrypsin (AAT) deficiency and is … [Read more...] about Safety study of inhaled alpha1-proteinase inhibitor for CF to begin this year

GlaxoSmithKline and Theravance have announced results from four Phase 3 studies of its umeclidinium bromide (UMEC)/vilanterol (VI) combination DPI for the treatment of COPD. The studies include two 24-week efficacy studies and two 24-week active comparator studies comparing UMEC/VI with tiotropium. UMEC is a a long-acting muscarinic antagonist (LAMA) and vilanterol is … [Read more...] about Results from four Phase 3 studies of GSK’s LAMA/LABA inhaler for COPD

Regency Therapeutics has announced the initiation of the 18-month AMPED (Acute Management of Pain from the Emergency Department) registry study to compare patient response to Sprix ketorolac tromethamine nasal spray used to treat pain in emergency departments to outcomes for patients prescribe oral narcotics. The study will be conducted in 15 hospitals, including the … [Read more...] about Regency launches study of Sprix ketorolac nasal spray

Civitas Therapeutics has announced the initiation of a Phase 2a clinical trial of its CVT-301 inhaled L-dopa for the treatment of motor fluctuations in patients with Parkinson’s disease. CVT-301 is formulated and delivered using the company's proprietary Arcus dry powder technology. Development of the product is being funded in part by the Michael J. Fox Foundation … [Read more...] about Civitas initiates Phase 2a study of inhaled L-dopa

Alnylam Pharmaceuticals says that its ALN-RSV01 inhaled RNAi drug failed to meet the primary endpoint of a Phase 2b study, not significantly reducing the incidence of bronchiolitis obliterans syndrome (BOS) at 180 days after infection in lung transplant patients infected with respiratory syncytial virus (RSV) in an “intent-to-treat” (ITTc) analysis, but that it met … [Read more...] about Alnylam inhaled RSV drug misses primary endpoint in Phase 2b study

Boehringer Ingelheim has presented data from studies of olodaterol and tiotropium at the 2012 Annual Meeting of the American Thoracic Society. According to the company, it has now completed its Phase 2 trials of olodaterol, delivered via the Respimat soft mist inhaler, as a monotherapy for COPD, and that Phase 3 trials are also complete. BI is also developing a fixed … [Read more...] about Boehringer Ingelheim announces results from studies of olodaterol and tiotropium

US Health and Human Services Secretary Kathleen Sebelius has announced a national plan to fight Alzheimer’s disease that includes almost $8 million in funding for research related to an insulin nasal spray for the treatment of the disease. An article published in the Archives of Neurology in September 2011 described positive results from the SNIFF (Study of Nasal … [Read more...] about US plan to fight Alzheimer’s includes funding for development of insulin nasal spray

Elevation Pharmaceuticals has announced that a Phase 2b study of its EP-101 glycopyrrolate inhalation solution in patients with moderate to severe COPD demonstrated that EP-101 produced statistically significant improvement in lung function compared to placebo after 7 days. The GOLDEN-1 (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) study … [Read more...] about Positive Phase 2b results for Elevation’s glycopyrrolate inhalation solution