Mimetas said today that it collaborated with Roche (OTC:RHHBY) to develop an organ-on-a-chip system that is designed to evaluate intestinal permeability in 3D gut tubules following exposure to drug compounds. The results of the collaboration were published in Nature Communications. The researchers reported that the intestinal tubules were leak-tight after just four days in culture and […]
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Glytec lands another 510(k) clearance for diabetes management software
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 […]
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 […]
Cancer diagnostic detects unique mutations in small amount of blood
Researchers from Stanford University have developed a new diagnostic tool that can detect genetic mutations in small amounts of tumor-derived DNA circulating in a patient’s blood sample. The single color digital PCR assay needs a fraction of a tube of blood and can successfully detect three mutation-bearing molecules in a single reaction, according to the […]
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 […]