Sunovion Pharmaceuticals Inc.

325 articles with Sunovion Pharmaceuticals Inc.

• Sunovion Announces the Commercial Launch of KYNMOBI™ (apomorphine hydrochloride) Sublingual Film for the Treatment of Parkinson’s Disease OFF Episodes

  10/5/2020

  Sunovion Pharmaceuticals Inc. (Sunovion) today announced that KYNMOBI™ (apomorphine HCI) sublingual film is now available in the U.S. by prescription for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD). KYNMO

• Sunovion Answers Is Named a J.D. Power 2020 Certified Customer Service ProgramSM

  9/22/2020

  Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the Company’s support services program, Sunovion Answers, has been named as a J.D. Power 2020 Certified Customer Service Pro

• XENLETA® (lefamulin) Receives Health Canada Approval for Treatment of Community Acquired Pneumonia-XENLETA to be marketed exclusively in Canada by Sunovion Pharmaceuticals Canada Inc.

  7/16/2020

  Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that its partner, Sunovion Pharmaceuticals Canada Inc., has received approval from Health Canada to market oral and intravenous (IV) formulations of XENLETA® (lefamulin) for the treatment of community-acquired pneumonia (CAP) in adults.

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  Clinical Catch-Up: July 6-10

  7/13/2020

  Everybody seems to be back to work after the U.S. 4th of July holiday. Here’s a look at last week’s clinical trial updates.

• Sunovion Announces Topline Results from Global Phase 2 Study of SEP-4199 in Patients with Bipolar I Depression

  7/6/2020

  Sunovion Pharmaceuticals Inc. (Sunovion) today announced topline results from study SEP380-201 , a global, multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety, and tolerability of treatment with SEP-4199, an investigational oral medicine for the treatment of major depressive episodes associated with bipolar I disorder (bipolar I depression). SEP-4199 is

• Urovant Sciences Announces Collaboration with Sunovion Pharmaceuticals

  6/18/2020

  Urovant Sciences (Nasdaq: UROV) today announced it has entered into an exclusive three-year distribution agreement with Sunovion Pharmaceuticals Inc. (Sunovion) for services to support the commercialization of vibegron, an investigational agent for the treatment of overactive bladder. Both companies are subsidiaries of Sumitomo Dainippon Pharma Co., Ltd. The co-promotion agreement will enable

• AMSA and Sunovion Team Up For Second Year of Neuroscience Peer Teaching Program While Transitioning to Remote Learning Experience

  6/17/2020

  The Advanced Math & Science Academy Charter School (AMSA) and Sunovion Pharmaceuticals Inc. (Sunovion) today announced completion of the second year of a program to help students understand Science, Technology, Engineering and Math (STEM) life science career paths within a pharmaceutical company and foster a deeper knowledge of neuroscience. Six AMSA upper school level students, five seniors and one junior, we

• Sunovion Announces Health Canada Approval of KYNMOBI™ (apomorphine hydrochloride) Soluble Film for the Treatment of Parkinson’s Disease OFF Episodes

  6/15/2020

  Sunovion Announces Health Canada Approval of KYNMOBI™ (apomorphine hydrochloride) Soluble Film for the Treatment of Parkinson’s Disease OFF Episodes - First and only sublingual therapy approved for the on-demand treatment of Parkinson’s disease OFF episodes - MISSISSAUGA, Ontario--( BUSINESS WIRE )-- Sunovion Pharmaceuticals Inc. (Sunovion) announced today that Health Canada has approved KYNMOBI™ (apomorphine HCI) soluble film for the acute, inter

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  FDA Gives Thumbs-Up to Sunovion's Under-the-Tongue Parkinson's Drug

  5/22/2020

  “Today’s approval of Kynmobi advances treatment options for people with Parkinson’s disease who experience OFF episodes and the associated disruption of everyday activities,” said Antony Loebel, Sunovion’s president and chief executive officer.

• Sunovion Announces U.S. FDA Approval of KYNMOBI™ (apomorphine hydrochloride) Sublingual Film for the Treatment of Parkinson’s Disease OFF Episodes

  5/21/2020

  Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has approved KYNMOBI™ (apomorphine HCI) sublingual film (APL-130277) for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD).

• Sunovion Discontinues Dasotraline Program

  5/13/2020

  Sunovion Pharmaceuticals Inc. (Sunovion) today announced that it has withdrawn the New Drug Applications (NDAs) for dasotraline, a novel dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of moderate-to-severe binge eating disorder (BED) and attention deficit hyperactivity disorder (ADHD). While Sunovion considers dasotraline to be a promising, novel treatment for BED and ADHD, we believe t

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  FDA Action Alert: Blueprint, Bristol Myers Squibb, Clovis and Sunovion

  5/11/2020

  Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here’s a look at what’s on the schedule for the next two weeks.
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  Clinical Catch-Up: April 13-17

  4/20/2020

  There’s plenty of news related to clinical trials related to COVID-19, but it does seem to be drowning out non-COVID-19-related clinical trials. Here’s a look.

• Sunovion Announces FDA Filing Acceptance of Resubmitted New Drug Application for Apomorphine Sublingual Film

  12/20/2019

  Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease (PD), which was resubmitted on November 21, 2019.

• Sunovion Announces Results from Its Open-Label Extension Study of SEP-363856 in Schizophrenia

  12/12/2019

  Sunovion Pharmaceuticals Inc. (Sunovion) today announced results from study SEP361-202 which evaluated the long-term safety and effectiveness of SEP-363856, a novel non-dopamine 2 (D2) agent under investigation for the treatment of patients with schizophrenia.

• Sunovion Resubmits New Drug Application for Apomorphine Sublingual Film

  11/22/2019

  Sunovion Pharmaceuticals Inc. (Sunovion) today announced the resubmission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease (PD) in response to the January 29, 2019 Complete Response Letter (CRL).

• Sunovion President and CEO Dr. Antony Loebel Receives Outstanding Leadership Award at CNS Summit

  11/14/2019

  The award was presented to Dr. Loebel by Dr. Amir Kalali, Chairman and Chief Curator of CNS Summit.

• PsychoGenics Announces Milestones Associated with Sunovion’s Advancing Pipeline

  10/30/2019

  Two Compounds Discovered Using PsychoGenics’ SmartCube® Platform Have Entered Clinical Development

• Sunovion Answers Becomes a J.D. Power 2019 Certified Customer Service Program℠

  9/30/2019

  Sunovion’s support services program is recognized by J.D. Power for providing an outstanding customer service experience

• Sunovion and PsychoGenics Initiate DIAMOND Phase 3 Clinical Studies for SEP-363856 in the Treatment of Adults and Adolescents with Schizophrenia

  9/27/2019

  Sunovion Pharmaceuticals Inc. and PsychoGenics Inc. announced the initiation of the DIAMOND (Developing Innovative Approaches for Mental Disorders) Phase 3 studies for SEP-363856, a novel agent for the treatment of adults and adolescents with schizophrenia.