A new study of AxoSim’s Nerve-on-a-Chip technology shows that the platform accurately provides key physiological readouts that could help speed the development of drugs to treat neurological disorders. The study also shows that Nerve-on-a-Chip technology is the first all-human in vitro model that can measure critical factors that were formerly only available using live animal models. […]
Kurve, Suerat partnered in nasal-delivery migraine treatment deal
Kurve Technology last week announced a new development and collaboration agreement with Seurat Therapeutics for migraine prevention in adults. Mill Creek, Wash.-based Kurve Technology develops and markets intranasal drug delivery devices that transport liquid compounds from the nose to the brain to treat Alzheimer’s PTSD, multiple sclerosis and more. “Both Seurat and Kurve are proud […]
Kurve Technology wins DoD contract for drug delivery tech
Kurve Technology won a U.S. Defense Dept. contract to test a new formulation for combating traumatic brain injuries. The Mill Creek, Wash.-based company makes a controlled particle dispersion device designed to deliver liquid drugs through a controlled, turbulent flow, according to the company’s website. Its ViaNase electronic atomizer can deliver most drug compounds through the […]
Teva wins EU nod for Ajovy migraine prophylactic
Teva (NYSE:TEVA) said yesterday that it won EC Marketing Authorization in the European Union for its Ajovy pre-filled syringe injection meant to serve as a prophylaxis for migraines in adults who experience at least four migraine days per month. The Israel-based company said that Ajovy is a humanized monoclonal antibody that binds to the calcitonin gene-related […]
Sage wins historic FDA nod for postpartum depression therapy
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 […]
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. “We are pleased […]
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 […]
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 […]
FDA committee backs J&J’s nasal spray for depression
An FDA advisory committee has voted to support Johnson & Johnson‘s (NYSE:JNJ) Spravato esketamine nasal spray product as a therapy for adults living with treatment-resistant depression. J&J’s Janssen touted that if the U.S. regulatory agency decides to approve Spravato, it would be the first medicine in 30 years to sport a new mechanism of action […]
FDA rejects Alkermes depression drug NDA
Alkermes (NSDQ:ALKS) said last Friday that the FDA rejected the company’s new drug application for its ALKS 5461 drug intended to treat patients with major depressive disorder. The Dublin, Ireland-based company’s ALKS 5461 once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with MDD for whom standard antidepressant therapies have […]
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