Safety will be the focus July 15 when the FDA’s Cardiovascular and Renal Drugs Advisory Committee dives into the data for Fibrogen Inc.’s roxadustat as a treatment for anemia due to chronic kidney disease.
Precipio Inc. reported the launch of its Hemescreen anemia panel, part of a suite of diagnostic tests that run on the Hemescreen physician office laboratory (POL) testing system. The new panel is intended to help physicians tackle a difficult challenge – deciphering anemias of unknown cause.
The Institute for Clinical and Economic Review (ICER) took Fibrogen Inc., of San Francisco, to task for not disclosing data from completed roxadustat trials.
It might not have helped Iron Man survive use of the Infinity gauntlet, but for individuals with chronically iron-poor blood, Sanguina Inc. ’s new mobile app could be a lifesaver. Atlanta-based Sanguina released Anemocheck Mobile, an app that measures hemoglobin levels, for the Google Play Store and will shortly add the app for iOS. Anemocheck analyzes a photo of the user's fingernail beds and provides the hemoglobin level on the screen. Hemoglobin levels provide the most common measure of anemia.
HONG KONG – Astellas Pharma Inc. reported positive results from phase III of its DOLOMITES study comparing the efficacy and safety of roxadustat to that of darbepoetin alfa in treating anemia in nondialysis-dependent, stage 3 to 5 chronic kidney disease (CKD) patients.
HONG KONG – Astellas Pharma Inc. reported positive results from phase III of its DOLOMITES study comparing the efficacy and safety of roxadustat to that of darbepoetin alfa in treating anemia in nondialysis-dependent, stage 3 to 5 chronic kidney disease (CKD) patients.
Marking a key advance for Akebia Therapeutics Inc. in the global race to establish a new class of medicines for chronic kidney disease-associated anemia, the first of its two pivotal phase III programs proved its lead candidate, vadadustat, noninferior to darbepoetin alfa in adults on dialysis.
HONG KONG – South Korea's Chong Kun Dang (CKD) Pharmaceutical Corp. received approval for its novel erythropoiesis stimulating protein (NESP) biosimilar from Japan's Ministry of Health, Labour and Welfare (MHLW). The drug (CKD-1110) is world's first NESP biosimilar to treat anemia.
HONG KONG – South Korea's Chong Kun Dang (CKD) Pharmaceutical Corp. received approval for its novel erythropoiesis stimulating protein (NESP) biosimilar from Japan's Ministry of Health, Labour and Welfare (MHLW). The drug (CKD-11101) is world's first NESP biosimilar to treat anemia.
