Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has accepted a new supplemental New Drug Application for its Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery. The Bedford, Mass.-based company’s device is designed to deliver drugs for up to 30 days following treatment in a physician’s office. Ocular Therapeutix is […]
Valeritas (NSDQ:VLRX) said today that it inked an exclusive distribution deal with Tritech Biomed to commercialize its V-Go wearable insulin delivery device designed for patients with Type 2 diabetes in Israel. Through the deal, the Bridgewater, N.J.-based company said that Tritech Biomed will have rights to promote, market and sell the V-Go system to diabetes clinics […]
Privately-held Breath Therapeutics said today that it kicked off a Phase III clinical program for its liposomal formulation of cyclosporine A for the treatment of bronchiolitis obliterans syndrome. The company’s primary drug candidate, L-CsA-i, is an inhaled therapy delivered via Pari Pharma‘s investigational eFlow nebulizer. Get the full story at our sister site, Drug Delivery Business News.
Medtronic (NYSE:MDT) responded to a study presented this week which highlighted usability concerns with its MiniMed 670G automated insulin pump, writing that the company had “made many enhancements to the system since the study was done which would likely mitigate many of the issues experienced.” Earlier this week, physicians from Boston Children’s Hospital reported that nearly one-fifth of participants […]
Data from an 83-person study of Medtronic‘s (NYSE:MDT) MiniMed 670G hybrid closed-loop insulin pump showed that nearly one-fifth of participants stopped using the device after struggling with the technical demands of the system, researchers reported. Medtronic’s MiniMed 670G device is designed to automatically track and adjust a patient’s blood sugar levels by measuring blood glucose every […]
Novartis (NYSE:NVS) has launched its Ultibro Breezhaler and Seebri Breezhaler in China for the treatment of chronic obstructive pulmonary disease. The Ultibro Breezhaler system is a once-daily fixed-dose combination of indacaterol and glycopyrronium bromide. Seebri Breezhaler is a fixed-dose formulation of glycopyrronium bromide. Get the full story at our sister site, Drug Delivery Business News.
Novocure (NSDQ:NVCR) said today that it kicked off a Phase 3 pivotal trial testing its Tumor Treating Fields therapy combined with paclitaxel in people with recurrent, platinum-resistant ovarian cancer. The 540-patient trial has a primary endpoint of overall survival, with secondary endpoints that include progression-free survival, objective response rate, severity and frequency of adverse events and […]
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 […]
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 […]
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 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 […]