An FDA advisory panel yesterday recommended approval for Novartis‘ (NYSE:NVS) CAR-T gene therapy. If approved, it would be the first ever treatment of its kind on the market. The panel voted unanimously, 10-0, to recommend that the FDA give its official nod. The company’s therapy genetically alters a patient’s own cells to fight acute lymphoblastic leukemia. […]
Food & Drug Administration (FDA)
FDA rejects Ocular’s Dextenza for a second time
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA rejected its resubmission of a new drug application for Dextenza. This is the second time that Ocular has received the FDA’s dreaded complete response letter for Dextenza. In July last year, the FDA denied approval for Ocular’s hydrogel plug after it discovered ‘deficiencies in manufacturing process and controls’ in a pre-new […]
Oramed to meet with FDA about late-stage clinical program for oral insulin capsule
Oramed Pharmaceuticals (NSDQ:ORMP) said today that the FDA scheduled an end-of-phase II meeting with the Jerusalem-based company for August 31. Oramed is developing an oral insulin capsule for the treatment of Type II diabetes. The company’s Phase IIb trial met primary and secondary endpoints, since the insulin capsule lowered patients’ blood sugar relative to a placebo. […]
FDA accepts Axium’s orphan designation request for intranasal Truveta
Axium Pharmaceuticals said today that the FDA accepted its orphan designation request for the intranasal administration of lorazepam, Truveta, in the treatment of Lennox-Gastaut syndrome. The High Point, N.C.-based company is developing a novel intranasal administration device for new formulations of existing drugs. Axium said the device is designed to bring about rapid onset of […]
Ocular seeks to extend regulatory timeline for Dextenza due to manufacturing concerns
Ocular Therapeutix (NSDQ:OCUL) said today that it submitted details of a manufacturing equipment change as an amendment to the new drug application resubmission for Dextenza, the company’s dexamethasone insert that is currently under review by the FDA. The FDA is slated to make a decision about the product’s regulatory approval by July 19. But the company recently […]
How FDA plans to help consumers capitalize on advances in science
By: Scott Gottlieb, M.D. We’re at a point in science where new medical technologies hold out the promise of better treatments for a widening number of vexing conditions. Over the last few decades, science has enabled fundamental advances in our understanding of the genetic and protein bases of human disease. These developments are already being […]
Ocular Therapeutix faces more manufacturing problems as FDA decision deadline looms
Shares in Ocular Therapeutix (NSDQ:OCUL) fell last week after the company revealed that it received another letter from the FDA about issues spotted by the regulatory agency during a pre-approval inspection of a manufacturing plant. This isn’t the first time that the company has dealt with manufacturing issues. In July last year, the FDA denied approval for Ocular’s hydrogel […]
FDA clears first new sickle cell treatment in 20 years
Emmaus Life Sciences said last week that the FDA approved its L-glutamine oral powder, Endari, as a therapy to lessen the complications of sickle cell disease in patients ages 5 and older. The drug’s approval was supported by data from a Phase III trial evaluating Endari compared to a placebo in 230 adults and children […]
Medtech stories we missed this week: July 7, 2017
From EnvisionTEC’s FDA approval to InVivo Therapeutics adding a new clinical site, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. EnvisionTEC wins FDA nod for 3D printing E-Denture material EnvisionTEC announced in a June 30 press release that it has received FDA approval for its E-Denture material […]
Endo pulls painkiller from the market following FDA request
Endo Pharmaceuticals (NSDQ:ENDP) said today that it will voluntarily pull its Opana ER painkiller from the market. The move comes just weeks after the FDA asked the company to pull the plug on its opioid, arguing that the benefits of the abuse-deterrent drug no longer outweigh the risks. To write off the remaining net book value […]