Amgen and UCB Provide Regulatory Update on Status of EVENITY ™ (romosozumab) in the EU

THOUSAND OAKS, Calif. and BRUSSELS, June 27, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the companies have been informed the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application for EVENITYTM (romosozumab) for the treatment of severe osteoporosis. The companies intend to submit a written notice for a re-examination by the CHMP. "After a fracture, postmenopausal women with osteoporosis are five times more likely to fracture in the subsequent year,1 and these fractures can be life-changing. Yet these patients often remain undiagn...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news

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Conclusion: These results provide a potential mechanism involving AMPK activation/ROS inhibition signaling pathway in osteogenic differentiation of BMSCs enhanced by resveratrol. It suggests that development of therapy towards ROS is an effective way for osteoporosis treatment. PMID: 31438780 [PubMed - in process]
Source: Redox Report : communications in free radical research - Category: Biochemistry Authors: Tags: Redox Rep Source Type: research
Authors: Al Elq AH Abstract Intravenous bisphosphonates are widely used in the management of solid tumors, metastatic bone disease, metabolic bone diseases and hypercalcemia of malignancies. Recently, yearly intravenous injections of zoledronic acid, one of the potent nitrogen-containing bisphosphonates, have also been approved for the prevention and treatment of osteoporosis. Although infrequently observed, asymptomatic hypocalcemia mainly due to intravenous bisphosphonates has been documented. Here we report a female patient who exhibited profound symptomatic hypocalcemia after receiving intravenous zoledronic ac...
Source: Oman Medical Journal - Category: Middle East Health Tags: Oman Med J Source Type: research
Publication date: Available online 22 August 2019Source: The Lancet Diabetes &EndocrinologyAuthor(s): Sundeep Khosla
Source: The Lancet Diabetes and Endocrinology - Category: Endocrinology Source Type: research
This study is registered with, number NCT02176382.FindingsBetween Oct 15, 2014, and June 10, 2016, 269 women were assessed for eligibility. 76 participants were randomly assigned to 20 μg teriparatide (n=39) or 40 μg teriparatide (n=37), of whom 69 completed at least one post-baseline visit. At 15 months, mean spine aBMD had increased to a significantly greater extent in the 40 μg group (17·5% [SD 6·0] increase) than the 20 μg group (9·5% [3·2]; difference 8·1%, 95% CI 5·5 to 10·6, p
Source: The Lancet Diabetes and Endocrinology - Category: Endocrinology Source Type: research
This article reviews the effect of estrogens and progestogens on bone and presents new data of the currently approved drospirenone-only pill. The use of progestin-only contraceptives leading to an estradiol level between 30 and 50 pg/ml does not seem to lead to an acc elerate bone loss.
Source: Osteoporosis International - Category: Orthopaedics Source Type: research
This study searched for articles in PUBMED, CINAHL, Medline, EM-BASE, and Cochrane, and identified 3486 unique articles. These articles were screened based on predefined inclusion and exclusion criteria. Seven articles addressing time to normalization of either CTX, PINP, osteocalcin, or bone-specific alkaline phosphatase after a recent fracture were identified and these were analyzed qualitatively. CTX appeared to return to baseline within 6  months. PINP appeared to return to baseline within 6 months and interestingly dip below baseline after a year. Osteocalcin was elevated throughout the first year after a fr...
Source: Osteoporosis International - Category: Orthopaedics Source Type: research
We describe the time course of bone formation marker (P1NP) decline in men exposed to ~  3 weeks of sleep restriction with concurrent circadian disruption. P1NP declined within 10 days and remained lower with ongoing exposure. These data suggest even brief exposure to sleep and circadian disruptions may disrupt bone metabolism.IntroductionA serum bone formation marker (procollagen type 1 N-terminal, P1NP) was lower after ~  3 weeks of sleep restriction combined with circadian disruption. We now describe the time course of decline.MethodsThe ~  3-week protocol included two segments: &ldqu...
Source: Osteoporosis International - Category: Orthopaedics Source Type: research
Authors: López-Quiles J, Forteza-López A, Montiel M, Clemente C, Fernández-Tresguerres JA, Fernández-Tresguerres I Abstract BACKGROUND: The aim of this study was to assess the effect of local application of IGF-I on osseointegration of dental implants placed in osteoporotic bones. MATERIAL AND METHODS: 16 rabbits were randomly distributed into two groups: eight animals were ovariectomized and fed a low-calcium diet for six weeks, in order to induce experimental osteoporosis, and the others were sham-operated and fed a standard diet. A titanium implant was inserted into the tibiae in ...
Source: Medicina Oral, Patologia Oral y Cirugia Bucal - Category: ENT & OMF Tags: Med Oral Patol Oral Cir Bucal Source Type: research
Despite its increasing national incidence, osteoporosis and its associated co-management often remain an overlooked issue in the orthopedic world. In the majority of the scenarios, screening and associated management of osteoporosis is only considered by providers when patients present with multiple fragility fractures. Current evidence with regards to the trends in screening and medical co-management/antiresorptive therapy of osteoporotic vertebral compression fractures (VCFs) remains limited.
Source: The Spine Journal - Category: Orthopaedics Authors: Source Type: research
Osteoporosis/osteopenia is identified as a contraindication for total disc replacement (TDR). However, investigation into the utility of DEXA scanning for screening cervical TDR candidates has been limited.
Source: The Spine Journal - Category: Orthopaedics Authors: Tags: Wednesday, September 25, 2019 3:35 – 5:05 Section on Motion Technology Source Type: research
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