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 […]
Clinical Trials
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 […]
Novartis backs off from 2016 date for testing Google autofocus lens
Novartis (NYSE:NVS) is reportedly backing off a 2016 start date to test its autofocusing contact lens in clinical trials, but it told Reuters that the product is “progressing steadily” in its collaboration with Google (NSDQ:GOOGL). In 2014, CEO Joe Jimenez said he hoped the lens would be on the market in 5 years and last year he said his […]
Athenex, Lilly ink clinical collaboration for 1st oral formulation of paclitaxel
Athenex said today that it inked a clinical collaboration deal to conduct a phase Ib study for its oral form of paclitaxel, Oraxol, with Eli Lilly‘s (NYSE:LLY) vascular endothelial growth factor (VEGF) receptor 2 antagonist, Cyramza. Patients with advanced gastric and esophageal cancer will be enrolled in 2017 at sites in the U.S. and Asia, where […]
Mallinckrodt touts data for Ofirmev injected acetaminophen
Mallinckrodt Pharmaceuticals (NYSE:MNK) today released results from a clinical pharmacokinetic study evaluating the effect of IV morphine on the absorption of oral acetaminophen, touting the effectiveness of its Ofirmev IV administered acetaminophen over orally administered acetaminophen in adjunct to IV morphine. The results were presented at this year’s Pain Medicine Meeting of the American Society of […]
DBV, BioNet-Asia study needle-free pertussis booster vaccination
DBV Technologies (NSDQ:DBVT) and BioNet-Asia said today that the independent Data & Safety Monitoring Board positively reviewed DBV’s needle-free vaccine patch technology, Viaskin, and that enrollment in a Phase I trial for booster immunization against pertussis will continue into the 2nd dosing cohort. The Viaskin pertussis booster vaccination program will test the ability of DBV’s needle-free vaccine […]
Adherium touts Smartinhaler asthma study
Adherium (ASK:ADR) touted data from an independent study of its Smartinhaler respiratory disease management tool in children with poorly controlled asthma. The STAAR study was conducted at Sheffield Children’s Hospital in the UK and the results were published this month in Thorax. The New Zealand-based company found that in children with poorly controlled asthma, introducing its […]
Handheld breathalyzer as noninvasive blood glucose monitor in development
Researchers from the Western New England University developed a device the size of a small book that diabetes patients can use to monitor their blood glucose levels. Unlike traditional finger-stick testing, this minimally invasive breathalyzer uses acetone levels in patients’ breath to determine blood glucose levels. The team, led by Ronny Priefer and Michael Rust, presented […]
Injectable Regeneron biologic therapy reduces triglycerides, cholesterol
Researchers from the University of Pennsylvania presented preliminary data from a trial evaluating Regeneron Pharmaceutical‘s (NSDQ:REGN) injectable biologic drug therapy for reducing triglyceride levels. The team, led by Dr. Richard Dunbar, presented their work at the annual meeting of the American Heart Assn. The Phase I, placebo-controlled, double-blind study tested the safety and efficacy of Evinacumab, an […]
