Sunovion Pharmaceuticals Inc.

299 articles with Sunovion Pharmaceuticals Inc.

• Sunovion Announces Appointment of Dr. Antony Loebel as President and CEO, Effective April 1, 2019

  3/4/2019

  Sunovion Pharmaceuticals Inc. announced the appointment of Antony Loebel, M.D., to the role of President and Chief Executive Officer, effective April 1, 2019.

• Aquestive Therapeutics Provides Update on Licensee, Sunovion Pharmaceuticals Inc.'s Apomorphine Sublingual Film (APL-130277) New Drug Application

  1/31/2019

  APL-130277 is a medicine to treat OFF episodes (the re-emergence or worsening of Parkinson's symptoms otherwise controlled by medications) experienced by people living with Parkinson's disease

• Sunovion Receives Complete Response Letter from FDA for Apomorphine Sublingual Film (APL-130277)

  1/31/2019

  Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration issued a Complete Response Letter for the New Drug Application for apomorphine sublingual film to treat OFF episodes experienced by people living with Parkinson’s disease.

• 

  FDA Rejects Sunovion Pharmaceutical’s Parkinson’s Disease Treatment

  1/31/2019

  The regulatory agency issued a Complete Response Letter to the Marlborough, Mass.-based Sunovion, the company said this morning. After reviewing the New Drug Application, the FDA said it could not approve the application for the apomorphine sublingual film in its present form.

• Sunovion and PsychoGenics Announce Positive Results from Pivotal Phase 2 Study of Novel Investigational Agent SEP-363856 for the Treatment of Schizophrenia

  12/13/2018

  SEP-363856 was identified through a collaboration between Sunovion and PsychoGenics

• 

  AstraZeneca Unloads Three Asthma and Rhinitis Drugs to Covis Pharma for $350 Million

  11/6/2018

  AstraZeneca is unloading rights to Alvesco (ciclesonide) to treat persistent asthma, and Omnaris and Zetonna (ciclesonide) to treat nasal symptoms associated with rhinitis. The company indicates that the rights cover markets outside the United States and the U.S. royalties for the drugs.

• Kedalion Therapeutics Broadens Leadership Team with Vice President of Engineering

  9/25/2018

  Kedalion Therapeutics, Inc. today announced the hiring of medical device industry veteran Reynaldo Quintana as Vice President of Engineering.

• Sunovion Announces Health Canada Approval of Aptiom® (eslicarbazepine acetate) as Adjunctive Therapy for the Treatment of Partial-Onset Seizures in Adolescents and Children Above Six Years of Age

  9/19/2018

  APTIOM provides an important new treatment option for adolescents and children above six years of age with partial-onset seizures

• Sunovion Announces Positive Top-Line Results from Pivotal Study Evaluating Dasotraline in Adults with Binge Eating Disorder

  7/25/2018

  Study met its primary endpoint demonstrating fewer binge days per week with dasotraline versus placebo in the treatment of adults with moderate to severe binge eating disorder.

• Sunovion to Launch Take On Tomorrow™ Giving Opportunity with Red Sox Foundation and 7th Annual Community Service Program

  7/17/2018

  Expecting to Reach 25,000 Cumulative Employee Volunteer Hours This Summer, Company Will Mark Milestone by Donating $25,000 to Support Education and Mental Health Initiatives

• 

  As Treatments Await FDA Ruling, Researchers Discover ‘Key Players’ in Early-Onset Parkinson’s Dis...

  6/15/2018

  While pharma and biotech researchers have been driving forward with therapies aimed at helping Parkinson’s disease patients, medical researchers have identified “unexpected new key players” in the development of early-onset Parkinson’s disease, called Parkinsonism.

• Sunovion Announces FDA Acceptance of New Drug Application for Apomorphine Sublingual Film (APL-130277)

  6/12/2018

  Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for apomorphine sublingual film (APL-130277)

• 

  Biotechs Develop Treatments Targeting Multiple Types of Mental Illness

  5/7/2018

  Approximately 25 percent of adults in the United States will deal with some form of mental illness within a given year. It’s also estimated that many of the people who experience these problems may never report it or seek help.

• Sunovion to Deliver Multiple Presentations at the 2018 American Psychiatric Association Annual Meeting

  5/2/2018

  – New data analyses highlight the use of Latuda® (lurasidone HCl) in pediatric populations, including long-term efficacy and safety outcomes in bipolar depression and schizophrenia – – Further data on use of dasotraline in children and adults with ADHD and adults with binge eating disorder (BED) will be presented –

• Sunovion Announces Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution Now Available in the U.S. for the Treatment of COPD

  4/3/2018

  LONHALA MAGNAIR is the first nebulized long-acting muscarinic antagonist (LAMA) available for the treatment of COPD in the U.S.

• 

  Sunovion Submits NDA for Sublingual Parkinson's Treatment

  3/30/2018

  Sunovion Pharmaceuticals announced it submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for apomorphine sublingual film to treat OFF episodes in Parkinson’s disease (PD).

• Sunovion Submits New Drug Application to the FDA for Apomorphine Sublingual Film (APL-130277) for the Treatment of OFF Episodes Associated with Parkinson’s Disease

  3/30/2018

  Submission is supported by Phase 3 clinical study data showing that the investigational medicine demonstrated superior efficacy versus placebo for the on-demand treatment of OFF episodes associated with Parkinson’s disease.

• 

  FDA Grants Sunovion’s Latuda Expanded Approval for Bipolar Depression in Pediatric Patients

  3/6/2018

  There is a newly approved treatment for pediatric patients with major depressing episodes associated with bipolar disorder.

• Sunovion Receives FDA Approval of Supplemental New Drug Application (sNDA) for Use of Latuda® (lurasidone HCl) in the Treatment of Bipolar Depression in Pediatric Patients (10 to 17 Years of Age)

  3/6/2018

  Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) that expands the use of Latuda® (lurasidone HCI) to include the treatment of major depressive episode associated with bipolar I disorder (bipolar depression) in pediatric patients (10 to 17 years of age).

• 

  Sunovion's Parkinson's Drug Succeeds in Late-Stage Trial

  1/30/2018

  The drug met its primary and key secondary endpoints, and the medicine was also generally well-tolerated by study participants.