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 […]
FDA rejects Sunovion’s NDA for Parkinson’s disease-treating apomorphine sublingual film
Sunovion Pharmaceuticals said yesterday that the FDA rejected its New Drug Application for its apomorphine sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease. The Marlborough, Mass.-based company’s product is a fast-acting therapy based on a novel formulation of an FDA-approved drug, apomorphine. Sunovion is assessing its apomorphine sublingual film as a therapy […]
Researchers question use of antibiotic shunts in hydrocephalus patients
Led by neurosurgeon Dr. Benjamin Warf, a team of researchers from Boston Children’s Hospital published a study this month questioning the benefits of using shunts impregnated with antibiotics to treat hydrocephalus. Hydrocephalus, which affects roughly 400,000 children each year, is characterized by fluid accumulation in the brain. Surgeons use shunts to drain the patient’s excess […]
Amneal wins FDA nod for generic rivastigmine transdermal patch
Amneal Pharmaceuticals (NYSE:AMRX) said today that it won FDA approval for a generic rivastigmine transdermal patch. The drug, which is sold under the brand name Exelon, is an acetylcholinesterase inhibitor that is commonly used to treat mild to moderate Alzheimer’s disease and Parkinson’s disease. The Exelon patch reeled in roughly $225 million in U.S. sales […]
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