Cumberland Pharmaceuticals (NSDQ:CPIX) said today that it acquired exclusive U.S. rights to Nordic Group‘s injectable methotrexate product line to treat rheumatoid arthritis, juvenile idiopathic arthritis, severe psoriatic arthritis, and severe disabling psoriasis. Nordic Group has registered the product line for patient use in European countries, so Cumberland will register and commercialize the products in the U.S. […]
Food & Drug Administration (FDA)
Cellnovo files 510(k) for connected diabetes management system
Cellnovo (EPA:CLNV) said today that it has filed for 510(k) clearance from the FDA for its diabetes management system. Paris-based Cellnovo touts its system as the 1st mobile, connected diabetes management system. Tubeless and compact, the company’s insulin pump has a mobile touchscreen controller with an integrated blood glucose meter. Data from insulin injections and blood-glucose levels are […]
OCUL’s Dextenza meets endpoints in pivotal study
Ocular Therapeutix (NSDQ:OCUL) said today that its post-surgical ocular pain reliever, Dextenza, met both primary endpoints in a pivotal trial for the treatment of post-surgical ocular inflammation and pain. The product is a bioresorbable intracanalicular insert, designed for drug release to the ocular surface for up to 30 days. The randomized, double-masked study enrolled 438 patients who were […]
Ocular Therapeutix plans FDA re-submission for Dextenza by end of year, earnings
Shares in Ocular Therapeutix (NSDQ:OCUL) surged this morning after the biopharmaceutical company met expectations on Wall Street with its 3rd-quarter results and announced it will re-submit its new drug application to the FDA for Dextenza, its post-surgical ocular pain reliever, by the end of the year. In July, the FDA denied approval for Ocular’s hydrogel plug designed […]
FDA warns Valeant on SPAG-2 nebulizer, OraPharma OnSet mixing pen
The FDA this month warned Valeant Pharmaceuticals (NYSE:VRX) on violations found during inspections of its Rochester, N.Y., plant last summer. The federal safety watchdog, in a Nov. 3 warning letter posted online today, wrote that inspections from Aug. 23 through Sept. 1 turned up problems with its small-particle aerosol generator, the SPAG-2 device, and a high-precision compound and dispensing […]
Propeller wins FDA nod for connected GSK Ellipta inhaler
Propeller Health said today that it won 510(k) clearance from the FDA to market its Propeller platform with GlaxoSmithKline‘s (NYSE:GSK) Ellipta inhaler. A sensor for the dry powder inhaler was built as a part of a 1 year-long development and R&D collaboration between Propeller and GSK. This marks the 8th clearance for Propeller’s connected inhaler platform. […]
Sernova, CTI ink regulatory deal for Cell Pouch System
Sernova said it inked a regulatory deal with CTI Clinical Trial and Consulting Services to further the clinical development and IND application for its Cell Pouch drug delivery system. The London, Ontario-based company’s Cell Pouch is an implantable device that acts as an environment within the body to store therapeutic cells for patients with chronic diseases. Cincinnati-based […]
FDA OKs stem cell-gene therapy trial for ALS
The FDA approved a combination stem cell-gene therapy clinical trial to test the treatment’s ability to slow the progression of amyotrophic lateral sclerosis. It’s the 1st clinical trial to use neural stem cells to deliver a particular protein in the hopes of slowing ALS progression, according to researchers at the ALS clinic at Cedars-Sinai Medical […]
Targazyme wins FDA clearance for Phase II bone marrow stem cell study
Targazyme said today that it will begin enrolling patients in a Phase II clinical study to evaluate TZ101-fucosylated bone marrow stem cells in cancer patients, after the FDA granted the San Diego-based company investigational new drug clearance. The treatment is designed to use blood-forming stem cells from bone marrow to restore the body’s ability to make blood […]
aTyr Pharma wins FDA fast track for muscular dystrophy therapy
aTyr Pharma (NSDQ:LIFE) said today that its candidate Resolaris was granted fast track designation by the FDA for the treatment of facioscapulohumeral muscular dystrophy, making it the 1st therapeutic candidate to receive the designation for the rare form of muscular dystrophy. Resolaris is derived from a naturally occurring protein released by human skeletal muscle cells. aTyr is […]
