The FDA has approved Sunovion Pharmaceutical‘s Lonhala Magnair system for the long-term treatment of airflow obstruction in people with chronic obstructive pulmonary disease, the company reported today. The drug-device combo, also known as Sun-101/eFlow, is the first nebulized long-acting muscarinic antagonist approved for the treatment of COPD in the U.S. The system includes a portable nebulizer […]
Mylan (NSDQ:MYL) and Theravance Biopharma, Inc. (NSDQ:TBPH) touted safety data yesterday from the late-stage trial of its once-daily inhaled bronchodilator, revefenacin, in patients with chronic obstructive pulmonary disease. If approved, revefenacin would be the first nebulized long-acting muscarinic antagonist on the market for COPD patients in the U.S. Get the full story at our sister site, Drug Delivery Business […]
Sunovion Pharmaceuticals said today that it plans to divest the U.S. market rights for its allergy and asthma products to Covis Pharma, in an effort to narrow its focus to the company’s COPD portfolio. Included in the deal is Sunovion’s Alvesco inhalation aerosol, its Omnaris nasal spray and its Zetonna nasal aerosol. All three products are ciclesonides […]
Sunovion Pharmaceuticals said today that the FDA accepted the revised new drug application for its eFlow chronic obstructive pulmonary disease drug-device combo. The submission follows a complete response letter that the FDA issued Sunovion in May. The Marlborough, Mass.-based company didn’t provide details as to why the FDA denied its initial application. Get the full story at our sister […]
The FDA issued a complete response letter to Sunovion Pharmaceuticals in regards to the new drug application for its eFlow chronic obstructive pulmonary disease drug-device combo. The investigational eFlow closed-system nebulizer delivers a long-acting muscarinic antagonist bronchodilator, glycopyrrolate, to reduce airflow obstruction in COPD patients. Get the full story at our sister site, Drug Delivery Business News.
Novartis (NYSE:NVS) said today that it out-licensed its U.S. commercial rights for 3 inhaled chronic obstructive pulmonary disease drugs to Sunovion Pharmaceuticals. Novartis will commercialize the Utibron Neohaler, Seebri Neohaler, and Arcapta Neohaler inhalation powders outside of the U.S. The Switzerland-based company will manufacture the powders for Sunovion, according to the agreement. Get the full story […]
Sunovion Pharmaceuticals said today that it will soon begin enrollment for a Phase IV study of its anti-epileptic drug Aptiom with Empatica‘s Embrace watch. The Marlborough, Mass.-based company touted its study as the 1st to incorporate a wearable seizure device with an anti-epileptic drug into the design of a clinical trial for partial-onset seizures. The Embrace watch […]
Sunovion Pharmaceuticals and the American College of Chest Physicians yesterday launched a strategic initiative called Delivery Makes a Difference to better understand patient and healthcare provider practices in COPD therapy. A series of “nationally recognized COPD thought leaders” came together to be a part of the steering committee for the initiative. They developed a survey for 1,000 […]