Sunovion Pharmaceuticals said yesterday that the FDA rejected its New Drug Application for its apomorphine sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease. The Marlborough, Mass.-based company’s product is a fast-acting therapy based on a novel formulation of an FDA-approved drug, apomorphine. Sunovion is assessing its apomorphine sublingual film as a therapy […]
FDA to review Sunovion’s apomorphine sublingual film for Parkinson’s disease
Sunovion Pharmaceuticals said today that the FDA accepted its new drug application for a sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease. The U.S. regulatory agency is slated to make a decision regarding Sunovion’s application by January 29. Get the full story at our sister site, Drug Delivery Business News.
Sunovion launches inhaled COPD therapy in U.S.
Sunovion Pharmaceuticals launched its Lonhala Magnair drug in the U.S. for the long-term maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease, the company reported today. Sunovion touts its drug as the first nebulized long-acting muscarinic antagonist approved to treat COPD in the U.S. The product is delivered using the Magnair nebulizer […]
Sunovion seeks FDA nod for sublingual film to treat Parkinson’s disease
Sunovion Pharmaceuticals submitted a new drug application to the FDA this week for its apomorphine sublingual film designed to treat motor fluctuations experienced by people with Parkinson’s disease. The Marlborough, Mass.-based company is testing the film as a therapy for Parkinson’s patients experiencing “off” episodes – when symptoms that are otherwise controlled by medications resurface. As […]
Sunovion touts pivotal Ph3 trial for Parkinson’s drug
Gearing up for a springtime FDA submission, Sunovion Pharmaceuticals reported today that its apomorphine sublingual film succeeded in a pivotal Phase III trial in patients with Parkinson’s disease who experience motor fluctuations. Without revealing the study’s full results, the Marlborough, Mass.-based company said that the trial met its primary and key secondary endpoints and that the drug […]
Sunovion wins FDA nod for inhaled COPD therapy
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, Theravance’s inhaled COPD therapy proves safe in late-stage trial
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 divests asthma, allergy tech to Covis Pharma
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 seeks FDA nod for COPD treatment – again
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 […]
FDA deals setback to Sunovion for inhaled COPD therapy
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.
Sunovion, Novartis ink licensing deal for inhaled COPD drugs
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 […]
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