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Bone and Mineral Metabolism Disorders News
AstraZeneca receives approval in Europe for hyperkalemia drug
Two years after the FDA turned down an application for its hyperkalemia drug ZS-9, AstraZeneca announced on March 22 that it has received approval for the drug from the European Commission under its new name, Lokelma. AstraZeneca said in a press release that it hopes to get U.S. approval for the drug later this year.
OPKO Health names renal division senior VP for clinical R&D
OPKO Health Inc. has named Akhtar Ashfaq, MD, FACP, FASN senior vice president, clinical research and development of the renal division.
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Alpha blockers more effective for large kidney stones
A new review of medical literature suggests alpha blockers may be useful in patients with large kidney stones. The study was published online Dec. 1 in The BMJ. http://www.bmj.com/content/355/bmj.i6112
European Commission approves Amgen’s Parsabiv
The European Commission has granted marketing authorization for Amgen’s Parsabiv (etelcalcetide) to treat secondary hyperparathyroidism (sHPT) in adult patients on hemodialysis. Parsabiv is the first calcimimetic agent that can be administered intravenously by a health care provider three times a week at the end of a hemodialysis session.
Latest DOPPS data shows changes in intradialytic weight loss, Vitamin D prescriptions
As a percentage of post-dialysis body weight, intradialytic weight loss has steadily declined from 3.2% in August 2010 to 2.7% in June 2016, suggesting decreases in Interdialytic Weight Gain over time, according to the latest data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor. DOPPS researchers will discuss this trend, including potential causes and implications, during a web conference on Thursday, Sept. 15, 2016 at 3 p.m. EDT. The discussion will cover the latest trends in U.S. hemodialysis data from the DPM (available at www.DOPPS.org/DPM) through June 2016. Register here .
FDA rejects Amgen’s NDA for secondary hyperparathyroidism drug Parsabiv
Satellite Healthcare has signed a four-year agreement to offer Baxter International Inc.’s Amia Automated Peritoneal Dialysis system to its peritoneal dialysis patients, and integrate the Revaclear dialyzer into its high-flux hemodialysis therapy offering. Details of the agreement were not disclosed.
KDIGO launches redesigned guideline app
Kidney Disease: Improving Global Outcomes (KDIGO) has launched a redesigned iOS and Android app. The new application, named KDIGO Mobile, offers a modern user interface and intuitive use experience, and provides access to the KDIGO library of clinical practice guidelines for nephrology, KDIGO said in a statement.
FDA approves Rayaldee to treat secondary hyperparathyroidism in chronic kidney disease patients
The U.S. Food and Drug Administration has approved OPKO Health Inc.’s Rayaldee (calcifediol) extended release capsules to treat secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Rayaldee is a patented extended release product containing 30 mcg of calcifediol (25-hydroxyvitamin D3).
Use caution when lowering blood pressure targets in CKD patients
Lower blood pressure targets can help prevent heart attacks, strokes, cardiovascular disease and death in chronic kidney disease (CKD) patients, according to data presented at the National Kidney Foundation 2016 Spring Clinical Meetings.
KDIGO seeks comments on updating guidelines for treating hepatitis C in chronic kidney disease patients
Kidney Disease: Improving Global Outcomes is seeking comments on a proposed scope of work to update the guidelines for treating hepatitis C in chronic kidney disease patients.
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