Immunovaccine Inc. said today that the European Medicines Agency granted orphan drug designation for its immunotherapy candidate for ovarian cancer in the EU. Orphan drug designation is granted to medicines intended for disease with a prevalence no greater than 5 in 10,000 people. According to the Nova Scotia-based company, ovarian cancer affects 3 per 10,000 […]
Regulatory/Compliance
FDA clears Allergan’s Xen gel stent for glaucoma
Allergan (NYSE:AGN) said today that it won FDA approval for its Xen gel stent and injector for glaucoma. The federal watchdog indicated the drug device for the management of refractory glaucoma, in cases where surgical treatment has failed or in patients with open angle glaucoma that is unresponsive to maximum tolerated medical therapy. The Dublin-based […]
Novo Nordisk, Sanofi win FDA nods for diabetes drugs
Both Novo Nordisk (NYSE:NVO) and Sanofi (NYSE:SNY) said yesterday that they won FDA approval for pre-filled pens with drug combinations indicated for adults with Type II diabetes. Paris-based Sanofi’s Soliqua 100/33 is an injectable medicine composed of 2 diabetes drugs – insulin glargine and lixisenatide. The drug is approved for adults with Type II diabetes not controlled with less than […]
FDA clears Ascensia’s Contour Next One blood glucose monitor
Ascensia Diabetes Care said today that it won FDA 510(k) clearance for its Contour Next One blood glucose monitoring system. The connected system features a blood glucose meter that links to mobile devices using Bluetooth through the Contour Diabetes app. The app can collect, store and analyze the patient’s blood glucose measurements for patterns and […]
Intarcia seeks FDA nod for 1st drug to use Medici drug delivery system
Intarcia Therapeutics said today that it submitted a New Drug Application to the FDA for its injection-free ITCA 650 candidate, the 1st drug to use Intarcia’s Medici drug delivery system to treat Type II diabetes. The ITCA 650 enables subcutaneous delivery of exenatide using a match-sized osmotic pump placed under the skin in an in-office procedure. With […]
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 […]
Zimmer Biomet touts preliminary data for stem cell therapy
Zimmer Biomet (NYSE:ZBH) touted data today from an investigational device exemption trial evaluating the use of autologous concentrated bone marrow aspirate for the treatment of critical limb ischemia. The stem cell study is the 1st pivotal trial of its kind to complete enrollment and a 1-year follow-up in a patient population that is ineligible for revascularization, […]
Novo Nordisk’s Fiasp wins EU nod; Danish firm plans emerging markets push
Novo Nordisk (NYSE:NVO) said today that the European Union’s Committee for Medicinal Products for Human Use issued a positive opinion on its fast-acting insulin analogue, Fiasp. The Danish company also committed to expanding its Changing Diabetes in Children program, which provides access to diabetes care and free insulin to children with Type I diabetes in developing countries. The […]
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 […]
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 […]
