Researchers from Boston University have developed a bionic pancreas system that outperformed conventional insulin pump therapy for patients with type 1 diabetes, according to a trial conducted at Massachusetts General Hospital. The team’s work was published in The Lancet. This device is the latest development in the race to make an entirely closed loop insulin pump system, […]
Drug-Device Combinations
Artificial leaf produces drugs using solar energy
Researchers from the Eindhoven University of Technology have reportedly developed a leaf-inspired mini-factory to produce drugs using solar energy. The team’s work could allow medicine to be made in resource-deprived areas, as long as there is sunlight. “Theoretically, you could use this device to make drug compounds with solar energy anywhere you want,” lead researcher […]
Eyenovia touts phase II study data
Eyenovia Inc. touted data from its phase II study evaluating the safety and efficacy of its high-precision ophthalmic microtherapeutics compared to conventional eyedropper treatment. The trial comes on the heels of a previous phase II study published in Therapeutic Delivery in October. New York-based Eyenovia’s trial demonstrated that its microdosing achieved superior pharmacologic effects and bioavailability compared to […]
21st Century Cures Act adds Hatch-Waxman rule to drug-device combos
Section 3038 of the 21st Century Cures Act applies Hatch-Waxman rules to certain drug-device combination products, addressing the regulatory pathway for devices that incorporate already approved drugs. The Hatch-Waxman Act, named for Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), was approved in 1984. It was designed to make it easier for generic drugs to enter […]
Amgen wins recommendation for single injection Repatha device
Amgen (NSDQ:AMGN) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for its Repatha single monthly injection device. The device is already cleared in Europe for dosing every 2 weeks. The hands-free device, with prefilled cartridges, delivers 420 milligrams of Repatha (evolocumab) in a single injection. […]
GSK launches phase III trial for inhaled triple combination therapy
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that they launched a phase III trial evaluating the triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with asthma. The companies’ triple combination therapy is made up of 3 drugs – an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta-adrenergic agonist. The treatment is delivered once a day using GSK’s […]
Japan approves Novocure’s Optune brain cancer treatment
Novocure (NSDQ:NVCR) said today that the Japanese Ministry of Health, Labor and Welfare has approved its tumor treating fields delivery system, Optune, for adult patients with supra-tentorial glioblastoma following surgery and radiation therapy. The St. Helier, N.J.-based company is expected to submit an application for public reimbursement of the device in Japan for newly diagnosed […]
Fresenius expands prefilled syringe portfolio
Fresenius (NYSE:FMS) business group Fresenius Kabi said today that it added its heparin sodium injection to the company’s Simplist prefilled syringe portfolio. The prefilled syringe for subcutaneous and intravenous bolus injections expands Fresenius Kabi’s available Heparin formulations. The Lake Zurich-Ill. company’s Simplist syringes have a 2-year shelf life and do not require any assembly or point-of […]
SMC acquires UK auto-injector developer Oval Medical Technologies
SMC Ltd., said today that it acquired auto-injector developer Oval Medical Technologies for an undisclosed amount. Cambridge, UK-based Oval Medical Technologies develops auto-injectors for a 2-step administration of non-viscous and viscous drugs using cyclic olefin plastic and glass primary drug containers. Somerset, Wisconsin-based SMC is a global contract manufacturer of single-use devices for pharmaceutical, medical […]
ClearLine wins CE Mark for intravenous line device
ClearLine MD said today that it won CE Mark approval for its ClearLine IV product line that prevents air from being introduced into intravenous lines. During IV infusion, ClearLine’s device detects air in the IV line using ultrasound and then removes the air to allow the fluid to flow continuously. Air embolisms can cause long-term clinical […]