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Bayer has announced that a Phase III trial evaluating its oncology compound Stivarga® (regorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC) has met its primary endpoint of a statistically significant improvement in overall survival. The study, called RESORCE, evaluated the efficacy and safety of regorafenib in patients with HCC whose disease has progressed after treatment with sorafenib. The safety and tolerability were generally consistent with the known profile of regorafenib. Detailed efficacy and safety analyses from this study are expected to be presented at an upcoming scientific congress.
Lerner Medical Devices, Inc. announced today that Levia®, a novel, in-home, ultraviolet B (UVB) phototherapy device, has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) for treatment of psoriasis and certain other skin conditions such as vitiligo.
Columbia University has awarded the 2016 Naomi Berrie Award for Outstanding Achievement in Diabetes Research to Peter Arner, MD, PhD, a Distinguished Professor in the Department of Medicine at the Karolinska Institute, whose studies on the turnover of fat tissue in the human body has revealed processes that contribute to obesity and diabetes.
Over 93 percent of heart attack patients are receiving stents within the guideline-recommended threshold of 90 minutes after arriving at the hospital, with the median time to stenting only 59 minutes, according to a broad report on trends in heart disease care from the American College of Cardiology's National Cardiovascular Data Registry published in the Journal of the American College of Cardiology.
GlaxoSmithKline plc and Innoviva, Inc. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion today supporting the use of Trelegy Ellipta in a broader group of patients with moderate to severe chronic obstructive pulmonary disease and that labeling, if approved, will be updated to further reflect its effect on exacerbations of COPD.
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