The FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices. In a letter to healthcare providers, the U.S. regulatory agency reported that there was […]
U.K., French regulators probe safety of paclitaxel devices
Taking a note from the FDA, U.K. and French regulators are investigating the safety of paclitaxel devices for the treatment of peripheral artery disease. Last week, the U.K. Medicines and Healthcare Products Agency said it ordered an inquiry into the safety of these devices following the publication of a meta-analysis that suggested a heightened risk […]
Xeris launches Ph2 trial of ready-to-use liquid glucagon
Xeris Pharmaceuticals (NSDQ:XERS) said today that it dosed the first patients in a Phase II trial of its ready-to-use liquid glucagon in people with Type 1 diabetes. The Chicago-based company expects to report top-line data from the study in the second half of 2019. The trial is slated to assess Xeris’ room-temperature stable liquid glucagon as […]
Aerie wins FDA nod for second glaucoma drug
Aerie Pharmaceuticals (NSDQ:AERI) said this week that the FDA approved the company’s once-daily eye drop Rocklatan for the treatment of elevated intraocular pressure in people with open-angle glaucoma or ocular hypertension. The Durham, N.C.-based company’s product is a fixed-dose combination of latanoprost and netarsudil – the active ingredient in Aerie’s first drug, Rhopressa. After winning an […]
Pops! Diabetes Care launches blood glucose monitoring system
Pops! Diabetes Care announced today the commercial launch of its blood glucose monitoring system. The Minneapolis-based company’s device won FDA clearance in December last year. The device can be attached directly to the back of a mobile phone and interacts with the user through a coaching app. The Pops! One system also allows users to […]
Alcyone wins breakthrough device status for delivery device
Alcyone Lifesciences said today that its ThecaFlex DRx system won breakthrough device status from the FDA. The Lowell, Mass.-based company’s system features an implantable subcutaneous port and intrathecal catheter used to provide access for cerebrospinal fluid aspiration and infusion of therapies. “The breakthrough device designation for the ThecaFlex DRx System is an important milestone in […]
Ocular Therapeutix posts mixed Q4 results
Shares in Ocular Therapeutix (NSDQ:OCUL) fell in premarket activity today after the company posted mixed fourth-quarter results. The Bedford, Mass.-based company posted a net loss of -$17.4 million, or -42¢ per share, on sales of $504,000 for the three months ended Dec. 31, for sales growth of 3.5% compared with the same period last year. Earnings […]
InfuSystem reports Q4, FY18 financial results
Shares in InfuSystem (NYSE:INFU) ticked up slightly today after the company reported its fourth-quarter and full-year financial results. The Michigan-based company posted a net loss of -$275k, or -1¢ per share, on sales of $17.6 million for the three months ended Dec. 31. Sales were down 7% compared to the same period last year. For the […]
Tandem addresses anomaly in pivotal trial for closed-loop tech
Tandem Diabetes Care (NSDQ:TNDM) said today that it plans to use its remote software update tool to address an anomaly found in an ongoing pivotal trial of its Control-IQ technology. The anomaly, according to Tandem, relates to how the company’s t:slim X2 insulin pump with Control-IQ technology handles continuous glucose monitoring data under undisclosed conditions. The […]
FDA approves J&J’s nasal spray for treatment-resistant depression
The FDA has approved Johnson & Johnson‘s (NYSE:JNJ) esketamine nasal spray for people living with treatment-resistant depression. The company’s product, Spravato, is an intranasal formulation of ketamine – a horse tranquilizer that is also known as Special K. The drug won support for approval from an FDA advisory committee earlier this year. Spravato is the […]
