Novaliq today launched its dry eye disease therapy, NovaTears, in New Zealand and said that it won registrational approval in Australia. The Germany-based company inked an exclusive licensing partnership earlier this year with AFT Pharmaceuticals (ASX:AFP) to commercialize Novaliq’s water-free topical eye drops in Australia. “NovaTears is a first-in-class treatment for this common and highly underserved […]
Clinical Trials
Medinol wins CE Mark for EluNir drug-eluting coronary stent
Medinol said today that it won CE Mark clearance for its EluNir drug-eluting stent – a device designed with a low metal footprint and an elastomeric coating. In one 958-patient clinical study, the coronary stent had a 12-month target lesion failure rate of 5.4% and a 0% rate of late stent thrombosis, proving non-inferior to […]
Meet 5 companies developing novel drug-delivery devices
At the 7th annual Partnership Opportunities in Drug Delivery event, presented by The Conference Forum, device companies gathered to tout their drug-delivery technologies and learn from each other’s mistakes and successes. Among them were needle-free injectors, patch pumps, auto-injectors and other novel delivery devices. Moderated by Pfizer‘s (NYSE:PFE) senior director of device strategy, Mathias Romacker, […]
FDA clears expansion of CeloNova’s nano-coated coronary stent trial
CeloNova Biosciences said today that the FDA approved an expansion of the on-going clinical trial for its Cobra PzF nano-coated coronary stent with 14-day dual antiplatelet therapy in complex patients, like people who are at a high risk of bleeding. The company touted its Cobra Reduce trial as the first randomized control trial to study […]
Ypsomed to supply Bigfoot with insulin infusion sets for pivotal trial
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 […]
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 […]
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. “Based on the preclinical and early feasibility study […]
Medtech stories we missed this week: Oct. 20, 2017
From InspireMD’s distribution deal to RenalGuard touting a new study, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD inks Chile distribution deal InspireMD announced in an Oct. 12 press release that it has signed a distribution deal with CorpMedical Chile to distribute the MGuard Prime […]
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. While one member of the FDA’s endocrinologic and metabolic drugs advisory committee abstained from voting, the other members voted 16-0 to […]
FluGen reels in $14m DoD award to test universal flu vaccine
FluGen has won a $14.4 million grant from the Defense Dept.’s Congressionally Directed Medical Research Program’s Peer Reviewed Medical research program’s mechanism to test its lead universal flu vaccine, RedeeFlu, the company said today. As part of the three-year award, the Madison, Wis.-based company will run two studies of RedeeFlu to show that the universal […]