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GSK Submits FDA New Drug Application for COPD Triple Combination Therapy

GlaxoSmithKline (GSK), together with Innoviva, recently announced GSK submitted a New Drug Application (NDA) with the U.S. FDA for the triple combination therapy FF/UMEC/VI (fluticasone furoate/umeclidinium/vilanterol) to treat chronic obstructive pulmonary disease (COPD). GSK announced earlier this year that it was planning to advance the timing of the filing with…

FDA Grants Marketing Clearance to Propeller Platform for Use with GSK’s Breo Ellipta Inhaler

Propeller Health recently announced that its Propeller platform has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for use with Breo Ellipta, GSK’s dry powder inhaler. On Dec. 1, 2015, Propeller, based in Madison, Wisconsin, and GlaxoSmithKline, headquartered in London, entered into a research and development agreement…

Sunovion Supports U.S. COPD and Epilepsy Awareness Month in November

Marlborough, Mass.-based Sunovion Pharmaceuticals is supporting several advocacy initiatives during the month of November in observance of the coinciding Chronic Obstructive Pulmonary Disease (COPD) and Epilepsy Awareness Months in the U.S., as well as World COPD Day on Nov. 16. Sunovion, a wholly owned subsidiary of Sumitomo Dainippon Pharma…

#CHEST2016 — Aerobika Reduces Medicine Needs, Clinical Costs Following COPD Exacerbations

The Aerobika device, developed by Monaghan Medical Corporation (MMC), is effective in reducing drug use and costs for patients with chronic obstructive pulmonary disease (COPD), according to a presentation at the recent American College of Chest Physicians (CHEST) annual meeting in Los Angeles. The Aerobika Oscillating Positive Expiratory Pressure (OPEP),…

Positive Phase 3 Trial Data of COPD Therapy Revefenacin Reported by Theravance and Mylan

Theravance Biopharma and Mylan recently reported positive Phase 3 trial data on the effectiveness of the drug revefenacin (TD-4208) for the treatment of chronic obstructive pulmonary disease (COPD). Revefenacin is an investigational long-acting muscarinic antagonist (LAMA) and the first once-daily nebulized bronchodilator in development to treat COPD. The drug will be…

New Drug Application for Sunovion’s COPD Therapy Accepted by FDA

The FDA recently accepted a New Drug Application (NDA) for Sunovion’s investigational treatment SUN-101 (glycopyrrolate) administered by the eFlow nebulizer to treat adults with chronic obstructive pulmonary disease (COPD). Although the FDA’s acceptance of the NDA for review does not guarantee approval, it is a crucial step in the drug approval process. Sunovian…