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 […]
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 of late […]
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. Get the full story at our sister site, Drug Delivery Business News.
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. Get the full […]
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. Get the full story at our sister site, Drug Delivery Business News.
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. Get the […]
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. Get the full […]
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 […]
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. Get the full story at […]
Valeritas (NSDQ:VLRX) posted its fourth-quarter and full-year financial results today, missing earnings estimates but topping revenue expectations on Wall Street. The Bridgewater, N.J.-based company posted a net loss of -$11.9 million on sales of $6.89 million for the three months ended Dec. 31, for sales growth of 19% compared with the same period last year. Get […]
Teva (NYSE:TEVA) said last week that it launched a generic version of Pfizer‘s (NYSE:PFE) Flector diclofenac epolamine patch. Using a nonsteroidal anti-inflammatory drug, the topical patch is designed to treat acute pain due to minor strains, sprains and contusions. Get the full story at our sister site, Drug Delivery Business News.