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 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 […]
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 […]
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.
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 […]
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 […]
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 […]
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 […]