Otsuka Pharmaceutical

Otsuka, Proteus Digital Health resubmit FDA application for first digital medicine

Tuesday, May 23, 2017

Otsuka Pharmaceutical and Proteus Digital Health announced that the FDA has acknowledged receipt of the New Drug Application (NDA) resubmission for the drug-device combination product of ABILIFY (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet. The NDA resubmission will now be reviewed by the FDA, with an anticipated action date by the agency in the fourth quarter of 2017.

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Novo Nordisk, Servier, Otsuka, Teva among top sponsors

Wednesday, March 1, 2017

Sponsors have done a good job of maintaining, but not improving, the overall quality of their relationships with investigative sites during the past two years, according to a new CenterWatch survey, but performance gaps have widened across several of the attributes sites identify as the most important for conducting a successful study.

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TransCelerate Biopharma turns three

Monday, June 1, 2015

The name alone excites many in clinical research. It’s the first—or so far best promoted—consortium consisting only of high-level people from big biopharmaceutical companies, each vowing to be deeply “pre-competitive” with one another while trying to rework some of the redundant and wasteful practices endemic to clinical research.

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Novo Nordisk, Takeda, Servier, Celgene among top sponsors

Sunday, March 1, 2015

Relationships between drug sponsors and investigative sites have become more effective during the past two years, according to a new CenterWatch survey, as the initiatives top sponsors have implemented in recent years to address site burdens—such as increased protocol complexity and insufficient study support—are beginning to have a positive impact.

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