Otsuka Pharmaceutical

New patient adherence tech tests the limits

Monday, November 27, 2017

With the FDA’s recent approval of Abilify MyCite, a “digital pill” that can indicate whether a patient has taken his or her medication, physicians may finally have an effective way of attacking the problem of medication nonadherence. Abilify MyCite is a drug-device combina-tion product that consists of Otsuka Pharmaceutical’s oral Abilify (aripiprazole) tablets that have been embedded with an ingestible biosensor developed by Proteus Digital Health.

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FDA approves pill with sensor to track patients adherence

Tuesday, November 14, 2017

The FDA approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

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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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