Proteus Digital Health has filed for Chapter 11 bankruptcy protection, noting that its efforts to raise money or sell the company fell victim to the COVID-19 pandemic. The Redwood City, Calif.-based company missed a $100 million funding target in December. Once valued at $1.5 billion, Proteus previously raised $420 million from investors including Novartis Venture Fund […]
Otsuka Pharmaceutical
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 […]
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. A late-stage trial showed that Abilify Maintena delayed the time […]
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. After 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 […]
FDA wants more from Proteus, Otsuka on 'smart pill'
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
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 […]
