According to Insmed Incorporated both the US and European patent offices are granting new patents related to the company's Arikace liposomal amikacin for inhalation to treat Pseudomonas aeruginosa lung infections in cystic fibrosis patients and for non-tuberculous mycobacteria (NTM) lung infections. The company says that the US Patent and Trademark Office (USPTO) … [Read more...] about Insmed gets two new patents for Arikace
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FDA advisory committee recommends approval of umeclidinium/vilanterol inhaler
The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 11 to 2 in favor of approval for GSK's Anoro Ellipta umeclidinium/vilanterol dry powder inhaler for the treatment of COPD, according to GlaxoSmithKline and Theravance. The committee voted 10-3 in agreement that the safety of the UMEC/VI inhaler has been demonstrated and 13-0 on the question of … [Read more...] about FDA advisory committee recommends approval of umeclidinium/vilanterol inhaler
Asthmapolis renames itself “Propeller Health”
Inhaler monitoring specialist Asthmapolis has announced that the company has changed its name to Propeller Health. The company said that the name change reflects a widening focus that includes products for inhaled COPD medications as well as asthma medications and that Propeller plans to offer additional asthma and COPD mobile apps and additional snap-on inhaler … [Read more...] about Asthmapolis renames itself “Propeller Health”
FDA issues draft guidance on BE for fluticasone propionate/salmeterol xinafoate
The FDA has issued a draft guidance on bioequivalence recommendations for generic fluticasone propionate/salmeterol xinafoate inhalers. Notice of the draft guidance appeared in the Federal Register for September 10, 2013. According to the agency, public responses to the draft guidance will be considered before the agency responds to a December 2009 citizen petition … [Read more...] about FDA issues draft guidance on BE for fluticasone propionate/salmeterol xinafoate
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
Nexus6 announces three new hires
Smartinhaler manufacturer Nexus6 has announced three new management appointments: Veronique Bouchet as VP of Business Development for Europe, Christopher Stevens as Chief Operating Officer, and Chris Mander as Head of Regulatory and Quality. According to the company, increased demand for its inhaler monitoring systems necessitated the expansion of its global … [Read more...] about Nexus6 announces three new hires
Capsugel to acquire Bend Research
Capsugel will acquire Bend Research for an undisclosed amount, the companies have announced. Bend will become part of Capsugel's Dosage Form Solutions (DFS) business unit. Although the press release highlights Capsugel's new "access to a premier suite of technologies to address customers’ most pressing formulation challenges for oral drug delivery," both companies … [Read more...] about Capsugel to acquire Bend Research
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