Sunovion Pharmaceuticals

Assessing the strategic impact of supply chain management

Thursday, June 15, 2017

The globalization of clinical trials and more complex protocols, which include adaptive designs and those for targeted therapies, have driven the need for new practices and strategies to reduce waste and inefficiencies in the clinical supply logistics area.

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MAGI Award for Excellence in Site Payments winners announced

Monday, June 5, 2017

Nimblify, a clinical trials technology company, helped announce the winners of the MAGI Award for Excellence in Site Payments at MAGI‘s Clinical Research Conference on May 22, 2017 in Philadelphia, Pennsylvania. Nimblify partnered with MAGI to perform an analysis on the state of the industry as it relates to site payments and to honor and recognize sponsors and CROs that pay sites promptly. Site customers of Nimblify’s parent company, Forte Research Systems, contributed data for hundreds of studies across 142 sponsors and CROs with nearly 32,000 payment records. Dr. Wendy Tate, director of Data Analytics at Nimblify, curated and analyzed the data to identify trends and averages in timeliness of payments made to sites.

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Sunovion touts positive results from ADHD pivotal study evaluating dasotraline

Monday, April 24, 2017

Sunovion Pharmaceuticals announced positive results of a pivotal phase III study (SEP360-305) evaluating the efficacy and safety of novel drug candidate dasotraline, a dopamine and norepinephrine reuptake inhibitor (DNRI) being evaluated in children 6 to 12 years of age with attention deficit hyperactivity disorder (ADHD). In a laboratory classroom setting, dasotraline showed persistent, statistically significant improvement in ADHD symptoms compared to placebo throughout the day (12 to 24 hours post-dose), demonstrating a duration of effect of up to 24 hours, and was generally well-tolerated.

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Sunovion receives NDA Acceptance for COPD treatment SUN-101/eFlow

Thursday, October 13, 2016

Sunovion Pharmaceuticals has announced that the FDA has accepted for review the New Drug Application (NDA) for SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist (LAMA), delivered via PARI’s innovative investigational eFlow closed system nebulizer, for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is May 29, 2017.

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Sunovion releases long-term data of biopolar depression treatment Latuda

Monday, May 23, 2016

Sunovion Pharmaceuticals has published results in the journal Depression and Anxiety from a six-month, open-label extension study that evaluated the long-term safety, tolerability and effectiveness of Latuda (lurasidone HCI) when used either as monotherapy or as adjunctive therapy in combination with lithium or valproate in adults with major depressive episodes associated with bipolar I disorder (bipolar depression).

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Sunovion releases positive data for COPD inhalation solution Brovana

Monday, May 23, 2016

Sunovion Pharmaceuticals has announced the results of a post-hoc analysis of a long-term safety study evaluating Brovana (arformoterol tartrate) Inhalation Solution in people with moderate-to-severe chronic obstructive pulmonary disease (COPD). Results from this analysis reinforce the use of Brovana in COPD, as measured by COPD exacerbation-related hospitalizations compared to those treated with placebo.

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Top issues facing ClinOps executives

Tuesday, December 1, 2015

Never before have operating conditions for clinical studies been more difficult. Clinical operations groups face growing pressure to get drugs to market faster while improving efficiencies and study quality. Development costs continue to rise. At the same time, the logistics of conducting a clinical trial have become more complex in the increasingly competitive and regulated environment.

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