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Otsuka inks collab deal to bring Abilify Mycite drug-device combo to US

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Otsuka Pharmaceutical (TYO:4578) said today it inked a collaborative deal with health management group Magellan Health to distribute its drug-device combo Abilify Mycite in the US. The Tokyo-based pharmaceutical company touted the Abilify Mycite system as the first FDA-approved drug-device combo designed to track drug ingestion, and said that the tracking data will be integrated into […]

The 10 most innovative medical devices of 2018

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The nominees for the best medical technology of 2018 were recently announced for the 12th Annual Prix Galien USA Awards. The host of the awards, The Galien Foundation, awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition. Before the candidates can qualify […]

Otsuka to acquire renal denervation firm ReCor Medical

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Otsuka Holdings (TYO:4578) said today that it plans to acquire the remaining stake it doesn’t already own in ReCor Medical and the renal denervation device it’s developing to treat hypertension. Tokyo-based Otsuka led ReCor’s $15 million Series D in April 2015 to back Palo Alto, Calif.- and Amsterdam-based ReCor’s Radiance-HTN study, which will test its Paradise system in patients […]

Otsuka Holdings to shift ReCor rights to medical device subsidiary

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Otsuka Holdings said this week it plans to move renal denervation assets it acquired commercialization rights it acquired last year to its wholly-owned subsidiary, Otsuka Medical Devices. The Japan-based company acquired the rights to commercialize ReCor Medical’s renal denervation technology last May after having invested in the company in 2014. Otsuka said that its board […]

FDA approves first pill with sensor to track ingestion

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The FDA today approved Abilify MyCite, the first drug in the U.S. to have an ingestible sensor embedded within the pill that can track if the medication was taken. The drug-device combination product is indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes linked with bipolar I disorder and as an […]

Injectable, extended-release bipolar drug wins FDA nod

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Otsuka Pharmaceutical (TYO:4578) and Lundbeck said last week that its extended-release injectable aripiprazole suspension, Abilify Maintena, won FDA approval as a maintenance monotherapy for adults with bipolar I disorder. The once-monthly intramuscular formulation was created by Otsuka and co-developed and commercialized with Lundbeck, the companies reported. Get the full story at our sister site, Drug Delivery Business News.

Proteus, Otsuka take another run at FDA approval for Abilify-smart pill combo

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Otsuka Pharmaceutical (TYO:4578) and Proteus Digital Health said today that the FDA accepted its resubmitted new drug application for their “smart pill”. The drug-device product combines Abilify and a Proteus ingestible sensor in a single tablet. The FDA is slated to make a decision on the NDA resubmission in the 4th quarter this year. Get the […]

Otsuka gets in on ReCor Medical’s Paradise renal denervation device

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ReCor Medical said it landed a strategic investment from Japanese conglomerate Otsuka Pharmaceutical (TYO:4578) that will bring to Asia its Paradise renal denervation device for treating hypertension. Neither side is disclosing financial terms, but the deal calls for Otsuka to receive exclusive rights to pursue clinical trials, regulatory approval and commercialization of ReCor’s Paradise device in Japan, China, Korea […]

FDA wants more from Proteus, Otsuka on ‘smart pill’

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Otsuka Pharmaceutical (TYO:4578) and Proteus Digital Health  said today that the FDA issued a complete response letter requesting more information from the companies for the combination of the Proteus “smart pill” and Otsuka’s Abilify anti-depressant drug. The Proteus pill is designed to signal a wearable patch after it reaches the stomach, recording and time-stamping data from […]

FDA to review Proteus ‘smart pill’ with Otsuka’s Abilify anti-depressant

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Otsuka Pharmaceutical (TYO:4578) and Proteus Digital Health said yesterday that the FDA will review a combination of the Proteus “smart pill” and Otsuka’s Abilify anti-depressant drug. The companies said the FDA accepted their new drug application for the drug-device combination, using the Proteus ingestible sensor and Otsuka’s aripiprazole drug in patients with serious mental illnesses such as major […]

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