The FDA has approved the first interchangeable biosimilars for denosumab.
Search results for: denosumab
FDA Issues Boxed Warning for Denosumab & Approves a Generic NSAID
In January, the U.S. Food & Drug Administration approved indomethacin in an oral suspension, a generic version of Indocin Oral Suspension. The agency also issued a boxed warning and updated label for denosumab, warning of the risks of severe hypocalcemia in patients with chronic kidney disease.
Patients on Dialysis Taking Denosumab May Be at Risk of Severe Hypocalcemia
The FDA is investigating the risk of severe hypocalcemia with serious outcomes, such as hospitalization and death, in patients on dialysis taking denosumab.
Denosumab vs. Zoledronate: An Analysis of Treatments for Low Bone Mineral Density in Patients with HIV
In a small study of men with low bone mineral density (BDM) living with HIV and taking anti-retroviral therapy, both zoledronate or denosumab were well tolerated and effective for bone mineral density of the lumbar spine and femoral neck.
Improving Bone Mineral Density: Risedronate vs. Denosumab
Treatment with denosumab for patients with RA and glucocorticoid-induced osteoporosis led to greater increases in bone mineral density of the lumbar spine and hips of patients than treatment with risedronate.
The Race Is On: Clinical Trials Begin for Agents Biosimilar to Denosumab
As the U.S. and other patents for branded denosumab products get closer to expiring, drug manufacturers are initiating clinical trials for more affordable, biosimilar versions of the treatment.
New Clinical Trials for Ustekinumab & Denosumab Biosimilars Begin Recruitment
Clinical trials of biosimilar treatments, including a phase 1 study of SB17, which is biosimilar to ustekinumab, and two phase 3 studies investigating of SB16, which is biosimilar to denosumab, are currently recruiting.
Denosumab Has Edge on Alendronate for Steroid-Induced Bone Loss
NEW YORK (Reuters Health)—Long-term glucocorticoid users see greater gains in spine bone-mineral density when treated with the monoclonal antibody denosumab vs. oral alendronate, a small clinical trial shows. The drug also proved superior at lowering bone-turnover markers at 12 months, researchers in Hong Kong report in Bone.1 “Denosumab may be considered as an alternative first-line…
Denosumab Promising for Osteolysis after Total Hip Replacement
NEW YORK (Reuters Health)—Denosumab showed biological efficacy against osteolysis after total hip replacement in a proof-of-concept trial. “Denosumab is already a well-established licensed drug for the indications of osteoporosis and metastatic bone lesions in cancer, and has been shown to be effective in reducing erosions in inflammatory arthritis,” Dr. Mark J.M. Wilkinson of the University…
New Findings on Hydroxychloroquine, Denosumab
ACR Convergence 2020—At two plenary sessions, speakers highlighted key findings, including results on the QTc interval in patients on hydroxychloroquine, and data from a study on denosumab vs. alendronate for glucocorticoid-induced osteoporosis. The QTc Interval & Hydroxychloroquine The safety profile and optimal dosing of hydroxychloroquine has been a topic for decades because it is known…
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