A study comparing the Resolute Onyx drug-eluting stent from Medtronic (NYSE:MDT) and the BioFreedom stent made by Biosensors International (PINK:BSNRY) showed the Medtronic device to be non-inferior in patients on a one-month dual anti-platelet therapy regimen, according to results presented yesterday at the annual Transcatheter Cardiovascular Technologies conference in San Francisco. Medtronic launched the 2,000-patient study […]
Clinical Trials
Tandem Diabetes Care touts real-world t:slim X2 insulin pump data
Tandem Diabetes Care (NSDQ:TNDM) yesterday touted real-world data from users of the t:slim X2 insulin pump. The data, from more than 8,000 users, was published in the medical journal Diabetes Technology & Therapeutics. San Diego-based Tandem said the study showed a 45% relative risk reduction in hypoglycemia and a 71% relative risk reduction in hypoglycemic events, […]
Pulmatrix doses first patient in Pulmazole trial
Pulmatrix (NSDQ:PULM) said yesterday that it dosed the first patient in its Phase II trial of Pulmazole for the treatment of allergic bronchopulmonary aspergillosis asthmatics. The 64-patient study is a randomized, double-blinded, placebo-controlled trial to evaluate the safety and efficacy of three dose levels of the anti-fungal drug itraconazole formulation Pulmazole. The multi-center, four-arm trial will […]
Halozyme-Genentech breast cancer pivotal meets endpoint
Halozyme Therapeutics today announced positive endpoint results from its phase III intravenous chemotherapy trial. Genentech’s FeDeriCa study used Halozyme’s Enhanze drug-delivery technology for subcutaneous administration of a fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin), in combination with intravenous chemotherapy. The results showed non-inferior levels of Perjeta in the blood compared to standard IV infusion […]
FDA approves ready-to-use liquid glucagon from Xeris
Xeris Pharmaceuticals (NSDQ:XERS) said yesterday that the FDA has approved its Gvoke glucagon injection for the treatment of hypoglycemia. Gvoke is a ready-to-use, room-temperature, stable liquid glucagon designed to treat severe hypoglycemia in pediatric and adult patients with Type 1 diabetes aged two years old or above. Chicago-based Xeris’ Gvoke may be administered with a pre-filled […]
Cook Regentec launches blood filtration trial for critical limb ischemia
Cook Medical’s Regentec division today announced the launch of a clinical trial to evaluate its HemaTrate blood filtration system to treat patients with critical limb ischemia (CLI) due to peripheral arterial disease (PAD). Indianapolis-based Cook Regentec said the HemaTrate system is designed to produce an autologous, peripheral blood-derived total nucleated cell (TNC) concentrate for intramuscular […]
Cook Medical touts paclitaxel-coated stent PAD study results
Cook Medical today touted five-year data from a study into the use of its Zilver PTX paclitaxel-coated stent for peripheral arterial disease (PAD). The study concluded that there was no increase in long-term all-cause mortality due to paclitaxel after treatment using the Zilver PTX stent compared to traditional angioplasty or a bare-metal stent, according to a […]
Satsuma Pharmaceuticals registers $75m IPO
Satsuma Pharmaceuticals has registered an initial public offering, seeking to raise $75 million, according to a regulatory filing. The South San Francisco-based company is working on STS101, a nasal powder version of dihydroergotamine for migraine. It intends to use the money to fund its Phase 3 safety and efficacy clinical trials for STS101, manufacturing costs, […]
Medtronic’s In.Pact AV DCB meets endpoints in trial
Medtronic (NYSE:MDT) said last week that its clinical study comparing the In.Pact AV drug-coated balloon to percutaneous transluminal angioplasty (PTA) met primary safety and effectiveness endpoints. The study pitted the In.Pact AV DCB against PTA in patients with de novo or non-stented restenotic arteriovenous fistulae lesions. Results were presented at the Cardiovascular and Interventional Radiology Society […]
Concept Medical wins FDA breakthrough nod for MagicTouch AVF drug-coated balloon
Concept Medical said yesterday that it won breakthrough designation from the FDA for its MagicTouch AVF drug-coated balloon. MagicTouch AVF is designed to treat stenotic lesions of arteriovenous fistulae or arteriovenous graft in hemodialysis treatment of renal failure. India-based Concept Medical’s device is indicated for use in percutaneous transluminal angioplasty. The PTA procedure, using Concept […]
