i2o Therapeutics says it acquired the diabetes-treating assets of one-time medtech unicorn Intarcia Therapeutics. The Boston-based company acquired and integrated Intarcia’s proprietary assets and made a big personnel move. With CEO Ravi Srinivasan moving onto other opportunities, i2o named Kurt Graves as chair, president and CEO. Graves previously served as executive chair of the i2o […]
Intarcia Therapeutics
Intarcia Therapeutics takes another run at FDA approval
Intarcia Therapeutics said last week that the FDA accepted its new drug application resubmission for ITCA 650 for the treatment of Type 2 diabetes mellitus. The Boston-based company originally resubmitted the NDA on Sept. 9. FDA told the company that it considered the NDA resubmission a complete class 2 response. The Prescription Drug User Fee Act […]
Intarcia slashes headcount after FDA rejects diabetes drug-device combo
Four months after the FDA rejected its diabetes drug-eluting implant, privately-held Intarcia Therapeutics has cut 60 employees and received a clinical hold for two of its ongoing marketing studies, according to reports. The company’s device is designed for the continuous, subcutaneous delivery of exenatide in people with Type II diabetes. It was rejected by the U.S. regulatory agency in […]
FDA deals setback to Intarcia for diabetes implant
Privately-held biopharma Intarcia Therapeutics revealed today that the FDA rejected its exenatide implant, ITCA 650, designed to treat Type II diabetes. The company said that it doesn’t think it will need to conduct new pivotal trials in order to address the concerns brought about by the FDA’s complete response letter. Get the full story at our sister […]
FDA accepts Intarcia’s NDA for diabetes drug-device combo
Intarcia Therapeutics said today that the FDA accepted its New Drug Application for the 1st drug to use Intarcia’s Medici drug delivery system to treat Type II diabetes. The Medici drug-device combo delivers exenatide subcutaneously using a match-sized osmotic pump placed under the skin in an in-office procedure. The subcutaneous delivery system uses technology to stabilize proteins, peptides, antibody fragments and […]
Intarcia, Calibr collaborate to develop peptide therapeutic for Medici pump
Intarcia Therapeutics and the California Institute for Biomedical Research said today that the 2 groups will collaborate to develop a peptide therapeutic for patients with type II diabetes and obesity. The drug will be derived from Calibr’s stapled-peptide technology platform, combined with Intarcia’s late stage investigational GLP-1 therapy and delivered using the match-sized Medici osmotic […]
Gates Foundation puts $140m into $206m round for Intarcia
Intarcia Therapeutics said today that it raised a $206m Series EE round and inked a deal with the Bill & Melinda Gates Foundation to fight HIV in emerging nations. It’s the 2nd of 3 tranches in an ongoing round for Intarcia, which is developing a drug-delivery platform called Medici, a match-sized osmotic pump designed to be placed under the […]
Intarcia seeks FDA nod for 1st drug to use Medici drug delivery system
Intarcia Therapeutics said today that it submitted a New Drug Application to the FDA for its injection-free ITCA 650 candidate, the 1st drug to use Intarcia’s Medici drug delivery system to treat Type II diabetes. The ITCA 650 enables subcutaneous delivery of exenatide using a match-sized osmotic pump placed under the skin in an in-office procedure. With […]
Intarcia raises another $215m to support its ITCA 650 drug pump
Intarcia Therapeutics said today that it raised $215 million in a new round of financing to back its ITCA 650 implantable drug pump, designed for treating Type II diabetes, which is slated to launch in late 2017. The Cambridge, Mass.-based company said it expects a “larger 2nd close with additional top-tier investors” in the 4th quarter. Intarcia is looking to raise up […]
Insulet touts new data showing reduced A1c levels with Omnipod system | American Diabetes Assn. 2016 Scientific Sessions
Insulet (NSDQ:PODD) last week touted the publication of new data supporting the benefits of its Omnipod insulin management system, with data supporting the systems’ efficacy at controlling blood glucose levels in patients switching from daily injections or tubed insulin pumps. Data from the company’s multi-center retrospective study was used in 2 online publications in the Journal […]
Ethicon study reports bariatric surgery as effective treatment for Asian Indian type II patients | American Diabetes Assn. 2016 Scientific Sessions
Ethicon study reports bariatric surgery as effective treatment for Asian Indian type II patients Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said it presented data from a study supporting bariatric surgery as a better treatment option than medical therapy and lifestyle management for obese Asian Indian patients with inadequately controlled type 2 diabetes. Data came from […]