• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Intarcia Therapeutics

Intarcia Therapeutics takes another run at FDA approval

October 15, 2019 By Sean Whooley

Intarcia Therapeutics

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 […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants Tagged With: FDA, Intarcia Therapeutics

Intarcia slashes headcount after FDA rejects diabetes drug-device combo

February 5, 2018 By Sarah Faulkner

Intarcia Therapeutics

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. […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants Tagged With: Intarcia Therapeutics

FDA deals setback to Intarcia for diabetes implant

September 28, 2017 By Sarah Faulkner

Intarcia Therapeutics

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 […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Implants, Pharmaceuticals, Regulatory/Compliance Tagged With: Intarcia Therapeutics

FDA accepts Intarcia’s NDA for diabetes drug-device combo

February 6, 2017 By Sarah Faulkner

Intarcia Therapeutics

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 […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Wall Street Beat Tagged With: Intarcia Therapeutics

Intarcia, Calibr collaborate to develop peptide therapeutic for Medici pump

January 9, 2017 By Sarah Faulkner

Intarcia Therapeutics

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 […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Research & Development, Wall Street Beat Tagged With: California Institute for Biomedical Research, Intarcia Therapeutics

Intarcia seeks FDA nod for 1st drug to use Medici drug delivery system

November 21, 2016 By Sarah Faulkner

Intarcia Therapeutics

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 […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants, Pharmaceuticals, Regulatory/Compliance Tagged With: Intarcia Therapeutics

Intarcia launches Medici drug delivery platform

June 7, 2016 By Fink Densford

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations Tagged With: Intarcia Therapeutics

Intarcia, Numab log milestones for autoimmune drug-device combo

June 2, 2016 By Brad Perriello

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 […]

Filed Under: Discovery, Drug-Device Combinations Tagged With: Intarcia Therapeutics, Numab

Diabetes: Medtronic furthers the quest for an artificial pancreas

June 15, 2015 By Fink Densford

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Research & Development Tagged With: Becton Dickinson, GI Dynamics, Glytec, Intarcia Therapeutics, Medtronic, Valeritas Inc.

Intarcia adds $225m for Type II diabetes trial

April 28, 2015 By Brad Perriello

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.

Filed Under: Drug-Device Combinations Tagged With: Intarcia Therapeutics

  • Go to page 1
  • Go to page 2
  • Go to Next Page »

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech 100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Souring
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS