The FDA announced today that it has approved the first generic naloxone hydrochloride nasal spray, a life-saving medication that is designed to stop or reverse opioid overdose effects. The FDA also said that it is planning new steps to prioritize the review of other generic drug applications that treat opioid overdose. Nearly 400,000 people have […]
FDA nixes Evoke Pharma’s gastro nasal spray
The FDA has rejected Evoke Pharma’s (NSDQ:EVOK) application for a metoclopramide nasal spray for diabetic women with gastroparesis. The Solana Beach, Calif. company’s stock price tumbled 40% on the news yesterday that the agency had found dosing inconsistencies in the pivotal pharmacokinetic study for the spray, Gimoti. In an earlier multi-disciplinary letter to the company, […]
Cigna lowers insulin price to $25 per month
Under pressure from patients and the FDA, Cigna (NYSE:CI) and Express Scripts said today that they will lower the price of insulin to $25 per month for some patients. Three firms — Eli Lilly, Novo Nordisk and Sanofi — control 90% of the global insulin market and produce all the insulin used in the U.S. […]
FDA accepts second application for Ocular Therapeutix’s drug-delivering implant
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 […]
Novo Nordisk seeks FDA nod for oral diabetes pill
Novo Nordisk (NYSE:NVO) said this week that it submitted applications to the FDA for its oral formulation of semaglutide, a once-daily glucagon-like peptide-1 receptor agonist therapy. The company is hoping its pill will be approved as an adjunct to diet and exercise to improve blood sugar control in adults with Type 2 diabetes. Novo Nordisk also […]
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 […]
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. “EOFlow was founded to democratize wearable drug delivery solutions […]
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 […]
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. After winning an […]
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 […]
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