Sage Therapeutics (NSDQ:SAGE) this week won FDA approval for the first medicine indicated to treat postpartum depression. The Cambridge, Mass.-based company’s injection therapy, Zulresso, is slated to be available in late June. Postpartum depression is the most common medical complication of childbirth, according to Sage, and affects roughly one in nine women who have given birth […]
Drug-Device Combinations
Surmodics shares down following FDA’s paclitaxel device update
Surmodics (NSDQ:SRDX) shares fell last week after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices. In an SEC filing, the company said that it’s working with the FDA to clarify how the company should proceed with an ongoing clinical trial of […]
EOFlow wins breakthrough status for wearable closed-loop insulin delivery tech
Korean medtech company EOFlow said last week that it won breakthrough status from the FDA for its closed-loop automated insulin delivery system for people with Type 1 diabetes. The EOPancreas system features a wearable patch, continuous glucose monitoring systems and a closed-loop blood glucose control algorithm. Get the full story at our sister site, Drug Delivery Business […]
Aptar Pharma touts FDA approval of nasal spray device
Aptar Pharma said this week that its Bidose nasal spray device won FDA approval for use with a breakthrough depression therapy. The Crystal Lake, Ill.-based company’s Bidose tech enables two-shot nasal drug delivery. Aptar touted its manufacturing facility in Congers, NY, which supports the manufacture of nasal and injectable drug delivery systems. Get the full story […]
FDA updates docs on review of paclitaxel devices for PAD
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 of late […]
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. Get the full story at our sister site, Drug Delivery Business News.
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. Get the full […]
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. Get the full story at our sister site, Drug Delivery Business News.
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. Get the […]
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. Get the full […]