Glytec said today that it won a fourth 510(k) clearance from the FDA for its insulin titration software, eGlycemic Management System featuring Glucommander. The latest FDA nod applies to product enhancements derived from user feedback, the Waltham, Mass.-based company said, including a streamlined transition of inpatients from IV to subcutaneous therapy and more robust workflow […]
Drug-Device Combinations
Amneal Pharmaceuticals issues voluntary recall of lorazepam droppers
Amneal Pharmaceuticals said today that it is voluntarily recalling 13 lots of its oral lorazepam product due to a defect in the dosing dropper. In some cases, the dropper is printed with the dose markings in reverse order or has no dose markings at all, according to the Bridgewater, N.J.-based company. So far, no adverse […]
Aradigm lands NIH grant for inhaled, liposomal products
Aradigm Corp. (NSDQ:ARDM) said today that the National Institute of Allergy and Infectious Diseases and the NIH awarded the company a grant to study the treatment of pulmonary non-tuberculous mycobacteria infections with Aradigm’s inhaled liposomal ciprofloxacin products, Linhaliq and Lipoquin. The two-year grant is worth approximately $972,000, according to the Hayward, Calif.-based company. The Phase II […]
Milestone Scientific logs Q2 beat
Injection device maker Milestone Scientific (NYSE:MLSS) topped expectations on Wall Street today with its second quarter results. The Livingston, N.J.-based company posted a net loss of -$1.5 million on sales of $2.5 million for the 3 months ended June 30, for bottom-line growth of 6.8% on sales growth of 4.2% compared with the same period last year. […]
Opthea touts data from wet-AMD trial
Opthea (ASX:OPT) touted additional data today from the Phase I/IIa trial of its wet age-related macular degeneration therapy, OPT-302. The 50-patient Phase I/IIa trial recruited participants who were either treatment-naive or previously treated with an intravitreal anti-VEGF therapy. Researchers evaluated OPT-302 as a monotherapy and in combination with Lucentis (ranibizumab). In treatment-naive patients who received OPT-302 […]
Tandem launches pivotal trial for predictive insulin pump
Tandem Diabetes Care (NSDQ:TNDM) said today that it enrolled the first patient in an at-home pivotal trial of its t:slim X2 insulin pump combined with the company’s predictive low glucose suspend algorithm. Using DexCom’s G5 mobile continuous glucose monitor and Tandem’s predictive technology, the insulin pump is designed to halt insulin delivery when it predicts low […]
Manufacturing drug device products: challenges and best practices
Integrating a drug with a mechanical device can, in some cases, improve patient outcomes and boost sales. But manufacturing these products is no simple feat: It often requires a specialized contract manufacturer with extensive experience in the field to make a drug-device combo buildable and scalable. There’s a lot to consider when manufacturing a medical […]
BioTime lands $2m for dry-AMD therapy
BioTime Inc. (NYSE:BTX) said today that its subsidiary, Cell Cure Neurosciences, has landed a $2 million grant from the Israel Innovation Authority for the development of its dry-AMD therapy, OpRegen. The Alameda, Calif.-based company’s OpRegen is an investigational therapy that delivers retinal pigment epithelial cells into the subretinal space to replace lost RPE cells. “This new […]
Ophthotech eye-drug trial fails to meet primary endpoint
Shares in Ophthotech (NSDQ:OPHT) dipped to $2.46 apiece this morning after the company announced that its Phase III wet age-related macular degeneration trial failed to meet its primary endpoint. The New York-based company said that the addition of Fovista (pegpleranib) to Eylea or Avastin, both anti-VEGF therapies, did not significantly improve visual acuity after 12-months compared […]
Medtronic launches DAPT study for Resolute Onyx DES
Medtronic (NYSE:MDT) said today that it’s launching a study of dual anti-platelet therapy and its Resolute Onyx drug-eluting stent. The 2,000-patient study is designed to compare a one-month course of aspirin and an anti-coagulant in conjunction with the Resolute Onyx device or the BioFreedom DES made by Biosensors International (PINK:BSNRY). The Resolute Onyx stent is made […]