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Sunovion Pharmaceuticals

FDA rejects Sunovion’s NDA for Parkinson’s disease-treating apomorphine sublingual film

January 31, 2019 By Fink Densford

sunovion

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Sublingual films Tagged With: Sunovion Pharmaceuticals

Sunovion looks to molecular clues, patient preferences to inform drug development

June 25, 2018 By Sarah Faulkner

sunovion

From discovery to commercial launch, drug development often takes years. New tools available to the industry, like the use of biomarkers and patient-reported outcomes, promise to help inform and speed up the process. “Being able to pick out the appropriate patients using the appropriate biomarkers and establishing a relationship between on-target pharmacology and any safety […]

Filed Under: Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Wall Street Beat Tagged With: Sunovion Pharmaceuticals

FDA to review Sunovion’s apomorphine sublingual film for Parkinson’s disease

June 13, 2018 By Sarah Faulkner

sunovion

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. The company’s product is a fast-acting therapy based on a novel formulation […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals Tagged With: Sunovion Pharmaceuticals

Sunovion launches inhaled COPD therapy in U.S.

April 3, 2018 By Sarah Faulkner

sunovion

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 […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Respiratory Tagged With: Boehringer Ingelheim Pharmaceuticals, Sunovion Pharmaceuticals

Sunovion seeks FDA nod for sublingual film to treat Parkinson’s disease

March 30, 2018 By Sarah Faulkner

sunovion

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Acorda Therapeutics, Sunovion Pharmaceuticals

Sunovion touts pivotal Ph3 trial for Parkinson’s drug

January 30, 2018 By Sarah Faulkner

sunovion

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Neurological, Pharmaceuticals, Sublingual films, Wall Street Beat Tagged With: Acorda Therapeutics, Sunovion Pharmaceuticals

Sunovion wins FDA nod for inhaled COPD therapy

December 6, 2017 By Sarah Faulkner

sunovion

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Respiratory, Wall Street Beat Tagged With: Boehringer Ingelheim Pharmaceuticals, Sunovion Pharmaceuticals

Mylan, Theravance’s inhaled COPD therapy proves safe in late-stage trial

July 20, 2017 By Sarah Faulkner

Mylan, Theravance

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. Revefenacin was generally well-tolerated among the 1,055 patients who participated in the […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: Boehringer Ingelheim Pharmaceuticals, Mylan, Sunovion Pharmaceuticals, Theravance Biopharma

Sunovion divests asthma, allergy tech to Covis Pharma

July 13, 2017 By Sarah Faulkner

sunovion

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 […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: covispharma, Sunovion Pharmaceuticals

Sunovion seeks FDA nod for COPD treatment – again

June 30, 2017 By Sarah Faulkner

Sunovion Pharmaceuticals

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. The U.S. regulatory watchdog is […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: Sunovion Pharmaceuticals

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