The FDA today released an update on Baxter‘s (NYSE:BAX) voluntary recall of its Vascu-Guard peripheral vascular patch, saying that it is working with the company but that neither group has discovered a root cause for the issues, which led to a number of adverse events and 3 potential patient deaths. The Vascu-Guard patch is designed […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA requests more info on IsoRay’s GammaTile
IsoRay (NYSE:ISR) said today that the FDA requested additional data on the company’s pending 510(k) application for its GammaTile radiation therapy system. The Richland, Wash.-based company’s GammaTile is a radiation system using Cesium-131 radiation seeds embedded in a collagen ’tile’ which is designed to be placed in surgical margins at the time of surgery. “This is […]
Novo Nordisk recalls cartridge holders in insulin delivery devices
Novo Nordisk (NYSE:NVO) launched a recall yesterday of insulin cartridge holders used in select batches of NovoPen Echo insulin delivery devices. The company said the cartridge holders could crack or break upon exposure to certain chemicals. Using a NovoPen Echo with a cracked or broken cartridge holder could result in the device delivering a lower dose […]
FDA expands indication for DigniCap chemotherapy device
The FDA today cleared the expanded use of Dignitana‘s DigniCap Cooling System as a tool to reduce hair loss during chemotherapy. This marks the 1st time the U.S. regulatory agency has cleared a cooling cap for use in cancer patients with solid tumors, according to the FDA. Hair loss is common in patients taking certain […]
Aequus to launch trial for anti-nausea patch
Aequus Pharmaceuticals (CVE:AQS) said today that it won approval from Health Canada to launch a proof-of-concept trial to evaluate the bioavailability and safety of the company’s long-acting transdermal anti-nausea patch. The device is made up of a combination of pyridoxine and doxylamine. The traditional form is delivered orally up to 4 times per day. Get […]
Edwards Lifesciences wins FDA approval for Inspiris Resilia valve
Edwards Lifesciences (NYSE:EW) said today that it won pre-market approval from the FDA for its Inspiris Resilia surgical aortic valve replacement, claiming it as “the first in a new class of resilient heart valves.” Irvine, Calif.-based Edwards said the valve uses its Resilia tissue technology, which is designed to inhibit calcification and improve hemodynamic performance and […]
Antibody could be first new mechanism of action for HIV treatment in 10 years
Theratechnologies (TSE:TH) said today that the FDA granted priority review to the biologics license application for ibalizumab as a treatment for multi-drug resistant HIV-1. If the monoclonal antibody is approved, it will be the first antiretroviral treatment with a new mechanism of action to be introduced in a decade. It would also be the only available […]
Ipsen wins approval for gastroenteropancreatic neuroendocrine tumor drug
Ipsen (EPA:IPN) said today that Teijin Pharma Ltd. won approval from the Japanese Ministry of Health, Labor and Welfare for Ipsen’s Somatuline as a therapy for gastroenteropancreatic neuroendocrine tumors. The subcutaneous drug was approved in Japan in 2012 for the treatment of acromegaly and pituitary gigantism. Get the full story at our sister site, Drug Delivery Business News.
Varian Medical wins FDA nod for Halcyon radiotherapy cancer treatment system
Varian Medical (NYSE:VAR) said today it won FDA 510(k) clearance for its Halcyon image-guided volumetric intensity modulated radiotherapy cancer treatment system. The Palo Alto, Calif.-based company said its Halcyon IMRT system features improvements that make it more comfortable for patients and streamline operator’s workflow, only requiring 9 steps from start to treatment, down from 30 steps […]
Abbott wins Health Canada nod for FreeStyle Libre glucose monitor
Abbott (NYSE:ABT) said today that its FreeStyle Libre glucose monitoring system won Health Canada approval for adults with diabetes. The company’s disposable glucose monitoring device is worn on the back of the upper arm and senses glucose using a small filament that is placed under the skin. Every scan includes a real-time glucose reading, as well […]
SteadyMed seeks FDA nod for Trevyent drug-device combo
SteadyMed (NSDQ:STDY) said today that it submitted a new drug application to the FDA for its drug-device pulmonary arterial hypertension therapy. The San Ramon, Calif.-based company’s lead product candidate is a combination of treprostinil and the PatchPump prefilled, disposable infusion system. Get the full story at our sister site, Drug Delivery Business News.