ARS Pharmaceuticals said this week that it won fast track status from the FDA for its investigational intranasal epinephrine spray, ARS-1. The San Diego, Calif.-based company’s device is designed to be an easy-to-use treatment for people suffering from severe allergic reactions to food, drugs and insect bites. Get the full story at our sister site, Drug […]
Late mortality rates ‘inadvertently reversed’ in 5-year study of paclitaxel-eluting stent
The journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors. In the first version of the paper, originally published in 2016, researchers reported that the 5-year all-cause mortality rate for people treated with Cook […]
Phillips-Medisize is offering connected health data services: Here’s how
One of the world’s largest medical device contract manufacturers, Phillips-Medisize is making a business play to provide the technological back end for connected drug delivery devices. Phillips-Medisize used to be all about the housings, assembly and packaging that went into finished drug-delivery devices. Electronics was something that other contract manufacturers did. Within a few years, […]
Abbott, Novo Nordisk ink deal for digital diabetes tools
Abbott (NYSE:ABT) said today that it inked a non-exclusive deal to integrate insulin dose data from Novo Nordisk‘s (NYSE:NVO) pre-filled and connected pens with its FreeStyle Libre mobile app and cloud-based system. The companies touted that integrating the products will allow healthcare professionals, caregivers and users to easily view glucose and insulin data, as well as make […]
Ocular Therapeutix doses first wet-AMD patient in implant trial
Ocular Therapeutix (NSDQ:OCUL) said today that it dosed the first patient in a study of its OTX-TKI tyrosine kinase inhibitor implant. The Phase I trial is slated to assess the bioresorbable device’s safety, durability and tolerability in people with wet age-related macular degeneration. Get the full story at our sister site, Drug Delivery Business News.
Hygieia wins FDA clearance for insulin management app
Hygieia said today that it won 510(k) clearance from the FDA for its insulin management app designed to optimize insulin dosing among people with Type 2 diabetes. The Michigan-based company touted its product as the first insulin management mobile app that can titrate individualized doses for all types of insulin regimens. Get the full story at […]
Phillips-Medisize is expanding in Wisconsin
Phillips-Medisize, a Molex company, has broken ground on a new manufacturing facility in Hudson, Wis., on the eastern end of the Minneapolis-St. Paul metro area. The 34-acre location at the St. Croix Meadows development will support at least 230,000 square feet of manufacturing space for FDA-regulated medical device products, Phillips-Medisize announced yesterday. After construction is complete […]
Cash-strapped Aradigm declares bankruptcy
Aradigm Corp. (NSDQ:ARDM) announced last week that it’s officially declaring bankruptcy. Strapped for cash, the Calif.-based company resigned to filing for Chapter 11 protection after it couldn’t confirm funding from its primary investor and partner, Grifols. Get the full story at our sister site, Drug Delivery Business News.
Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis
Medtronic (NYSE:MDT) said last week that it inadvertently omitted an undisclosed number of patient deaths from recent studies of its paclitaxel-coated balloons. The company noted that the mistake ultimately does not affect the conclusion that there was no statistically significant difference in all-cause mortality between its In.Pact Admiral drug-coated balloon and plain balloon angioplasty at five years. Get […]
Teva aims for 25% of U.S. EpiPen market by 2020
Teva (NYSE:TEVA) expects its generic EpiPen auto-injector to claim 25% of the U.S. market by the end of this year, according to a report from Seeking Alpha. For years, Mylan‘s (NSDQ:MYL) brand-name emergency allergy device has dominated the markets. But the company faced widespread criticism in 2016 when reports revealed that Mylan hiked the price of the EpiPen […]
Medtronic wins FDA’s breakthrough status for closed-loop insulin system
Medtronic (NYSE:MDT) said today that it won breakthrough status from the FDA for its investigational personalized closed-loop insulin pump system. The company touted its technology as enabling automated insulin delivery in a real-time, adaptable and personalized fashion. Get the full story at our sister site, Drug Delivery Business News.
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