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 […]
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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 […]
Delcath registers $10m offering
Delcath Systems (NSDQ:DCTH) proposed offering up to $5 million in units and $5 million in pre-funded units this week to fund the company’s clinical and commercial operations. The New York-based company plans to offer 500,000,000 units made up of Series C units with one share of common stock and Series E warrants to buy one share […]
How CHF Solutions is using health economics to expand product adoption
Two years after CHF Solutions (NSDQ:CHFS) acquired Baxter‘s (NYSE:BAX) Aquadex fluid filtration device for $5 million, the company’s executives are working to weave together the evidence they need to land reimbursement in the U.S. and expand patient access for its technology. The Aquadex system is designed to filter water and salt from patients experiencing fluid overload due […]
Illumina, Loxo Oncology partner for next-gen pan-cancer companion diagnostics
Illumina (NSDQ:ILMN) and Loxo Oncology (NSDQ:LOXO) are teaming up to develop a multi-gene panel for broad tumor profiling. The two companies ultimately hope to sell a next-gen sequencing-based companion diagnostic that will boast a pan-cancer indication. Illumina and Loxo plan to seek approval for a version of Illumina’s TruSight Tumor 170 test as a companion […]