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 […]
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. […]
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. Intarcia hinted that the reason behind the […]
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 […]
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 […]
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 launches Medici drug delivery platform
Intarcia Therapeutics said today it launched its subcutaneous Medici drug delivery system designed for the continuous delivery of medication. The Medici system is comprised of a matchstick-sized osmotic minipump placed just under the skin to deliver medication, a placement system for implantation and stabilization technology designed for proteins, peptides, antibody fragments and other high-potency small […]
Intarcia, Numab log milestones for autoimmune drug-device combo
Intarcia Therapeutics and pharmaceuticals maker Numab said today that they’ve logged several milestones in their joint project to develop a drug-device combination for treating inflammatory and autoimmune diseases. Wädenswil, Switzerland-based Numab identified a pair of antibody-based compounds for the program, which aims to use the delivery and formulation technology developed by Cambridge, Mass.-based Intarcia. The companies said […]
Diabetes: Medtronic furthers the quest for an artificial pancreas
Medtronic (NYSE:MDT) and Intarcia Therapeutics were in the spotlight at the American Diabetes Assn.’s annual scientific sessions conference in Boston last week, revealing new medical device developments in the fight against diabetes. Medtronic took center stage, announcing new developments for its artificial pancreas program, touting positive data from a user study of its MiniMed 640g and revealing plans to collaborate […]
Intarcia adds $225m for Type II diabetes trial
Intarcia Therapeutics yesterday took its total raise to more than $1 billion with a $225 million funding round it plans to use to run clinical trials and commercialize its the drug-device combination treatment it’s developing for Type II diabetes.
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