Ypsomed plans to supply Bigfoot Biomedical with a modified version of its Orbit infusion set for the pivotal trial of Bigfoot’s automated insulin delivery system, the companies said today. Ypsomed’s Orbit infusion sets can be rotated 360°, giving users the freedom to move around, and are fitted using a heat-activated patch. The infusion sets are available with steel or […]
OptiScan CEO: Glucose monitor approval is biggest advancement for ICU care in 10 years
Just last week, OptiScan Biomedical announced that its OptiScanner 5000 glucose monitoring system won 510(k) clearance for use in surgical intensive care units. The regulatory win was supported by eight rigorous clinical trials, CEO Peter Rule told Drug Delivery Business News, and represents a victory for a technology that the company hopes to expand into a platform system. Get the […]
Cerveau inks licensing deal with AbbVie for tau imaging agent
Cerveau Technologies has inked a deal to license and supply AbbVie (NYSE:ABBV) with its [F-18]MK-6240 investigational tau imaging agent, the company said today. After the FDA cleared the investigational new drug application for Cerveau’s imaging agent in June, the company said it planned to work with pharmaceutical partners to evaluate the product’s use in positron emission tomography scans to assess […]
United Therapeutics wins FDA nod for third-gen Tyvaso TD-300/A nebulizer
United Therapeutics (NSDQ:UTHR) said today that its third-generation inhalation device designed for use with its Tyvaso treprostinil inhalation solution won FDA approval. Tyvaso first won FDA approval in 2009 as a treatment for pulmonary arterial hypertension, the company said, with an ultrasonic nebulizer. United Therapeutics touted its drug-device combo as the most-prescribed inhalation therapy for PAD […]
FDA clears AstraZeneca’s once-weekly Type II diabetes drug-device combo
AstraZeneca (NYSE:AZN) said today that the FDA approved its once-weekly exenatide drug in a single-dose auto-injector for adults with Type II diabetes whose blood sugar is uncontrolled on one or more oral drugs. The company’s drug, Bydureon, is formulated with a continuous-release microsphere delivery system designed to provide consistent levels of exenatide, according to AstraZeneca, to […]
Surmodics goes head-to-head with Medtronic’s drug-coated balloon in pivotal trial
Surmodics (NSDQ:SRDX) announced today that the first patient was enrolled in a pivotal clinical trial evaluating its SurVeil drug-coated balloon. The 446-patient trial is designed to compare the company’s SurVeil device to Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon as a treatment for peripheral artery disease in the upper leg. Get the full story at our sister site, […]
Gottlieb updates on Puerto Rico med device manufacturing recovery
In the weeks following Hurricanes Irma and Maria, the people and leadership in Puerto Rico have been working to rebuild the island’s infrastructure. The FDA, which has been working with federal and local agencies, today provided an update to its efforts to help medical device manufacturers prevent potential shortages of medical devices like insulin pumps […]
Meet the two former Johns Hopkins residents disrupting the wound care market
Ned Swanson and Denver Lough were plastic surgery residents at Johns Hopkins when they made a choice that would change the course of their lives – they decided to drop out and start a business. Lough had a technology that they thought could help patients if it ever made it to the market, but their […]
This company helps cell therapies travel around the world
With Gilead Sciences (NSDQ:GILD) and Novartis (NYSE:NVS) leading the way, cell therapies are moving on to the market and into the clinics for patients that have no other option. Companies making CAR-T therapies use a patient’s own cells to genetically engineer a cancer-killing cellular therapy that is then delivered back to the patient. We are so grateful that we […]
Kite wins FDA approval for first adult CAR-T cell therapy
More than a month before it was due to make a decision, the FDA yesterday approved a CAR-T cell therapy from Kite Pharma (NSDQ:KITE) – the first of its kind for adults. The therapy, which is made from a patient’s own cells, is designed to treat adults with non-Hodgkin lymphoma who have failed at least two other […]
FDA committee backs Novo Nordisk’s once-weekly type II diabetes drug
An FDA advisory committee has voted favorably to approve Novo Nordisk‘s (NYSE:NVO) once-weekly semaglutide Type II diabetes drug. Shares in the insulin maker were up 2% in after-hours activity today, trading at $50.13 apiece. Get the full story at our sister site, Drug Delivery Business News.