Verily, Google’s life science’s sister company under Alphabet (NSDQ:GOOGL), has received an FDA 510(k) clearance to include an irregular pulse monitor in its Study Watch wearable. The FDA announcement, last updated Jan. 20, did not include additional information. The agency cleared ECG capabilities on the Study Watch in January 2019. Launched in April 2017, the Study […]
Proteus pivots, hands digital mental health adherence business to Otsuka
Proteus Digital Health is abandoning its mental illness and cardiovascular work in its digital pill technology after its deal with Otsuka Pharmaceutical (TYO:4578) ended prematurely and will start to focus more on therapeutic areas, STAT News reports. Otsuka Pharmaceutical had been paying Proteus to develop a portfolio of digital medicines for serious mental health conditions. […]
Proteus Digital Health restructuring amid reported funding woes
Proteus Digital Health said today that it is restructuring, reportedly because it failed to close a $100 million funding round. A report by CNBC said the Redwood City, Calif.-based company missed the funding target. Once valued at $1.5 billion, the company previously raised $420 million from investors including Novartis Venture Fund and Kaiser Permanente Ventures, […]
Otsuka inks collab deal to bring Abilify Mycite drug-device combo to US
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
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
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
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
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
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
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
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 […]
