Innovus Pharmaceuticals (OTC:INNV) said today that its GlucoGorx glucose monitoring kit, which includes a glucose meter, test strips and a lancet device, won 510(k) approval from the FDA. The San Diego, Calif.-based company plans to launch its blood sugar monitoring kit in the second half of this year. “We are very happy to be announcing the […]
CVS Health launches drug-pricing tool for pharmacies
CVS Health (NYSE:CVS) announced this week that it plans to launch a program to help consumers compare drug prices at the pharmacy counter. The company’s Rx Savings Finder program is designed to enable pharmacists to evaluate individual prescriptions and find the lowest cost option for consumers. The tool is available at all CVS Pharmacy locations, the […]
Livongo raises $105m for digital diabetes management platform
Livongo Health closed a $105 million round led by a group of investors including General Catalyst, Merck Global Health Innovation Fund and Echo Health Ventures. The Mountain View, Calif.-based company has developed Livongo for Diabetes – a collection of connected devices that enable people with diabetes to interact with a virtual care team. “We are particularly […]
FDA approves first AI-powered device to detect diabetic retinopathy
The FDA today approved the first medical device to harness artificial intelligence for the detection of diabetic retinopathy in adults who have diabetes. IDx’s software uses an algorithm to analyze images of the eye taken with a retinal camera. A doctor uploads the images to a cloud server with IDx-DR software, which then tells the […]
Mylan acquires fast-acting, non-opioid painkiller
Mylan (NSDQ:MYL) acquired global development and marketing rights to a fast-acting, non-opioid pain relief drug formulated by Prayog Labs, the company announced today. The pharma giant is positioning the medication, Meloxicam, as a non-addictive treatment option for patients experiencing acute pain following dentistry procedures or following a surgery. Prayog Labs has finished initial development work on […]
Inovio snags $56m award for Lassa fever, MERS vaccines
Inovio Pharmaceuticals (NSDQ:INO) inked a $56 million partnership with the Coalition for Epidemic Preparedness Innovations to develop vaccine candidates against Lassa fever and middle east respiratory syndrome. According to the terms of the deal, CEPI is slated to support Inovio’s preclinical and clinical efforts through to Phase II trials of INO-4500, its Lassa fever vaccine, and […]
FDA requests more info for TearLab’s eye diagnostic tech
TearLab Corp. (OTC:TEAR) said today that the FDA told the company it needs more information regarding its 510(k) application for the TearLab Discovery platform and test card designed to measure an inflammatory biomarker found in tears. The U.S. regulatory agency specifically took issue with the FDA-cleared predicated that TearLab chose to establish substantial equivalence. The company […]
JDRF tackles insulin consistency, potency at U.S. pharmacies
JDRF is teaming up with the American Diabetes Association and the Leona M. and Harry B. Helmsley Charitable Trust to support research evaluating the consistency and potency of insulin purchased at retail pharmacies in the U.S. The group called for proposals from analytical laboratories to assess the activity of insulin in vials and cartridges, looking […]
TherapeuticsMD negotiates label for vaginal capsule after NDA resubmission
TherapeuticsMD (NSDQ:TXMD) is negotiating with the FDA over the proposed label for its investigational, applicator-free estradiol vaginal capsule, TX-004HR, the company reported today. The softgel capsule is designed to treat moderate-to-severe vaginal pain experienced during sex, a symptom of vulvar and vaginal atrophy in women who have undergone menopause. The FDA is slated to make a […]
Mimetas lands $21m for organ-on-a-chip tech
Mimetas said today that it raised $20.5 million in a Series B round from a syndicate of investors in Asia and Europe. The Netherlands-based company intends to use its newly-acquired funds to support global commercialization efforts for its OrganoPlate organ-on-a-chip drug-testing platform. Mimetas added that it hopes to broaden its product portfolio and establish tissue […]
