Two studies have shown that romosozumab is effective for increasing bone mineral density in both men and women with osteoporosis. And due to safety concerns, Janssen has dropped out of clinical trials for fulranumab, which is being studied to treat OA pain…
The ACR Addresses the FDA about the Safe Adoption of Biosimilars in the U.S.; Plus Tofacitinib Approved for RA & Romosozumab May Reduce Fracture Risk
The ACR has continued its advocacy to ensure the safe adoption of biosimilars in the U.S., most recently addressing an FDA public hearing. Also, the FDA has approved tofacitinib for RA, and a clinical trial of romosozumab for patients with osteoporosis met its primary endpoint…
Amgen, UCB Say Osteoporosis Drug Meets Main Goal in Late-Stage Trial
(Reuters)—Amgen Inc. and Belgium-based UCB SA said on Monday that their osteoporosis drug met all the primary endpoints by reducing the incidence of new vertebral fracture in postmenopausal women with osteoporosis in a late-stage study. The topline results, from a Fracture study in postmenopausal women with osteoporosis (FRAME), showed that the drug romosozumab met a…
New Labeling for Infused Golimumab; Phase 3 Trial for Romosozumab Promising
The FDA has approved new labeling for infused golimumab to include measures of mental and physical health. Plus romosozumab meets primary endpoints in postmenopausal women with osteoporosis during a Phase 3 trial…
New Osteoporosis Drugs Show Promise in Therapy Pipeline
Rheumatologists at the ACR’s State-of-the-Art Clinical Symposium in Chicago discuss medication alternatives to bisphosphonates that reduce bone resorption, build bone density and may provide new treatment options