drug - Blog - Global Risk Community2024-03-29T07:53:28Zhttps://globalriskcommunity.com/profiles/blogs/feed/tag/drugGrowing Incidence of Osteoporosis And The Adoption Of Osteoporosis Drugshttps://globalriskcommunity.com/profiles/blogs/growing-incidence-of-osteoporosis-and-the-adoption-of2020-06-26T09:30:30.000Z2020-06-26T09:30:30.000ZKBV Researchhttps://globalriskcommunity.com/members/KBVResearch<div><p>Osteoporosis drugs are administered through different routes in the body, like orally or intravenously. Osteoporosis affects around 200 million people worldwide and is a progressive disease in which bones become more porous and fragile, often without symptoms until the first fracture occurs.</p><p></p><p><a href="{{#staticFileLink}}8028318652,original{{/staticFileLink}}" target="_blank"><img src="{{#staticFileLink}}8028318652,original{{/staticFileLink}}" class="align-center" alt="8028318652?profile=original" /></a></p><p></p><p>The World Health Organization reports that about 1.66 million hip fractures occur worldwide per year owing to osteoporosis. According to the National <a href="https://www.kbvresearch.com/osteoporosis-drugs-market/">Osteoporosis</a> Foundation, about 54 million Americans suffer from osteoporosis. The disease also has a genetic bias in that it affects more Caucasians than Asians. The incidence of the disease is lowest in the African community.</p><p></p><h2><strong>Osteoporosis drug classes:</strong></h2><h3><strong>Parathyroid Hormone Therapy</strong></h3><p>There has recently been a dramatic increase in the clinical study of parathyroid hormone ( PTH). There are no other anabolic agents on the horizon at present, but there are a large number of concerns that remain regarding this effective osteoporosis agent.</p><p></p><p>The present study discusses clinical trials utilizing PTH alone and in combination and sequence of antiresorptive agents in postmenopausal women and offers a brief review of glucocorticoid-induced osteoporosis studies in men. Because PTH improves microarchitecture, macroarchitecture, and bone density, it may have better long-term fracture protection when provided first and followed by antiresorptive therapy compared to antiresorptive agents alone.</p><p></p><h3><strong>Rank Ligand Inhibitors</strong></h3><p>When the rate of bone resorption exceeds that of bone formation, bone tissue destruction occurs, leading to a fragile skeleton. Clinical consequences, namely osteoporosis, and fracture fragility are common and severe problems.</p><p></p><p>Treatments that normalize bone turnover by inhibiting bone resorption preserve bone density and raising the likelihood of fracture. The identification of a key osteoclast activity regulator of the receptor activator of nuclear factor-B ligand (RANKL) offers a new therapeutic target. Initial tests have demonstrated that denosumab, an investigational, extremely selective anti-RANKL antibody, inhibits bone resorption quickly and substantially.</p><p></p><h3><strong>Bisphosphonates</strong></h3><p>Bisphosphonates are a type of osteoporosis drug used to reduce the loss of bone density and to treat osteoporosis and related diseases. These are the most widely used medications available for the treatment of osteoporosis. They are called bisphosphonates because they have two groups of phosphonates. They are also called diphosphonates. Bisphosphonates were prescribed as first-line therapy for postmenopausal osteoporosis.</p><p></p><p>Long-term treatments of bisphosphonates induce anti-fracture and bone mineral growth results that persist 3–5 years following the original 3–5 years of care. Biphosphonate alendronate decreases the risk of hip, vertebral, and wrist fractures by 35-39%; zoledronate reduces the risk of hip fractures by 38% and vertebral fractures by 62%. Risedronate has also been shown to reduce the possibility of hip fractures.</p><p></p><h2><strong>Factors behind the growing incidence of osteoporosis disorders:</strong></h2><h3><strong>Drugs and health conditions</strong></h3><p>Some illnesses or medications induce changes in hormone levels, and other medicines decrease bone density. Diseases affecting hormone levels include hyperthyroidism, hyperparathyroidism, and Cushing's syndrome. Research published in 2015 suggests that transgender women receiving hormone treatment (HT) may have an increased risk of osteoporosis. Nevertheless, the use of anti-androgens for a year before starting HT may reduce this risk.</p><p></p><p>Medical problems that raise the risk include certain autoimmune diseases, such as rheumatoid arthritis and ankylosing spondylitis, Cushing syndrome, adrenal gland dysfunction, pituitary gland disorders, among several others. Risk-enhancing medications include glucocorticoids and corticosteroids, including prednisone and prednisolone, thyroid hormones, anticoagulants and blood thinners, including heparin and warfarin, among many others.</p><p></p><h3><strong>Risk of Developing Osteoporosis Rises With Age</strong></h3><p>As with many chronic diseases, getting older puts you at a higher risk of osteoporosis. Currently, 1 in 4 American people over the age of 65 and 1 in 20 males over the same group have osteoporosis, according to the Centers for Disease Control and Prevention (CDC). In adults, bones undergo a continual cycle of breaking down and rebuilding, called remodeling. Osteoblasts make bones and osteoclasts break down the tissue in the bones and release the minerals into the blood.</p><p></p><p>The hormones androgen and estrogen have a role to play in the balance between bone breakdown and bone reconstruction. As people get older and these hormone levels drop, the bone is removed or damaged faster than the body can replace it, leaving bones weakened and vulnerable to fracture. Unhealthy lifestyle habits, such as smoking, alcohol, and lack of exercise, often raise the likelihood of having osteoporosis, as does long-term usage of some types of medication, including corticosteroids.</p><p></p><h3><strong>Osteoporosis In Males</strong></h3><p>Osteoporosis is a disease defined by decreased bone strength and increased risk of fractures. Classically, this disease has been a postmenopausal woman, although a significant health burden is increasingly recognized in men as well. Men experience higher mortality and morbidity from osteoporotic fractures compared to women. The lack of studies in men, the lack of reimbursement of DEXA scans in men and the lack of agreement among organizations are obstacles to the diagnosis and care of osteoporosis in men. Approximately 50% of men have an identifiable cause of osteoporosis, i.e. secondary osteoporosis.</p><p></p><p>When no cause is found after an extensive assessment, it is referred to as age-related osteoporosis in men over 70 years of age and idiopathic osteoporosis in men below 70 years of age. There are various reasons for a decreased risk of fracture in males compared to females. Bone mass accumulation begins from childhood and increases exponentially during puberty. While men appear to get this acceleration later than women, they may reach higher peak bone mass due to larger bones and greater periosteal expansion. Such wider bones contribute to improved biomechanical strength and decreased risk of fracture.</p><p></p><h2><strong>The bottom line</strong></h2><p>The osteoporosis drug market is growing at a rapid rate owing to the constantly rising rate of osteoporosis. There is a lack of osteoporosis drugs with a good safety profile that has been shown to reduce the risk of fracture in the elderly and the very elderly. Of all these purposes, the development of new bone active substances for the treatment of osteoporosis and the prevention of fractures is urgently needed.</p><p></p><p><strong>Free Valuable Insights:</strong> <a href="https://www.kbvresearch.com/news/osteoporosis-drugs-market/">Global Osteoporosis Drugs Market to reach a market size of USD 10.9 billion by 2026</a></p><p></p><p>According to the current treatment paradigm, antiresorptive drugs are the mainstay first-line therapy to reduce the risk of fracture in patients with osteoporosis and anabolic substances are usually only recommended in patients with severe osteoporosis. Since lost bone microarchitecture cannot be recovered, a future treatment paradigm may aim to reverse osteoporosis by maximizing bone mass and preserving bone microarchitecture during the early stage of disease progression.</p></div>Innovative Approaches to Drug Safetyhttps://globalriskcommunity.com/profiles/blogs/innovative-approaches-to-drug-safety2019-11-08T21:45:42.000Z2019-11-08T21:45:42.000ZVeronika Valdovahttps://globalriskcommunity.com/members/VeronikaValdova<div><h2><span>Innovative Approaches to Drug Safety</span></h2><p><strong>Date:<span> </span><span>15 November 2019</span></strong></p><p><strong>Time:<span> </span><span>1 to 5 PM EST</span></strong></p><p><span><strong><a href="https://www.engagez.net/node/216946?">REGISTER HERE</a></strong></span></p><p>Download <span> </span><a href="https://veracuity.com/wp-content/uploads/2019/11/Virtual-Workshop-invite-program.pdf">Virtual Workshop invite program</a></p><p><a href="{{#staticFileLink}}8028306666,original{{/staticFileLink}}" target="_blank"><img src="{{#staticFileLink}}8028306666,original{{/staticFileLink}}" class="align-full" width="786" height="524" alt="8028306666?profile=original" /></a></p><p class="has-text-align-left">The current practice of pharmacovigilance is fraught with challenges and limitations, but new technologies, perspectives, and concerns are shaping the way stakeholders will need to conduct this crucial activity in the coming years. You are cordially invited to join our workshop on the future of pharmacovigilance, which offers you an opportunity to participate in a robust, informative and professional discussion about the future of pharmacovigilance. We seek your perspectives on the issues before us today and how they will influence the drug safety environment in the 2020s.</p><p>You are cordially invited to join our workshop on the future of pharmacovigilance. We understand the challenges and limitations of the current ways to conduct the business of pharmacovigilance and seek your perspective to achieve broader consensus. Topics of interest include the role of stakeholders in shaping the informational needs, system responsiveness, production of real-world evidence, incentives and barriers to investment into automation and AI tools, the monetary value of safety information, patient privacy issues and innovative approaches toward generating evidence.</p><p>The cost of Adverse Drug Reactions and Adverse Drug Events is estimated at $3.5 billion a year but suspected to be $25 billion a year if unreported ADRs are considered. Consequences include increased costs for treatment, increased length of hospital stay, higher readmission rates, and higher in-hospital mortality.</p><p>By 2025, the outsourced pharmacovigilance market will be worth about $10.27 billion with an expected growth of 13.1% CAGR. The main drivers of this growth are regulatory requirements and increasing incidence of Adverse drug events due to an aging population and increasing demand for treatment for chronic diseases.</p><p>Pharmacovigilance needs reform to evolve beyond compliance in order to produce better quality, actionable intelligence that is responsive to the needs of stakeholders within the healthcare ecosystem, including healthcare providers and patients.</p></div>4th Adverse Events Reporting and Safety Strategies Summit | December 4–5, Philadelphia, PAhttps://globalriskcommunity.com/profiles/blogs/4th-adverse-events-reporting-and-safety-strategies-summit2017-10-19T13:40:04.000Z2017-10-19T13:40:04.000ZEmily Sternberghttps://globalriskcommunity.com/members/EmilySternberg<div><h2 align="center"><b style="font-size:13px;"> </b></h2><p><b>For more information, contact:</b> ExL Events<b> </b>FOR IMMEDIATE RELEASE</p><p><b>Phone:</b> 866-207-6528</p><p><b>Email:</b> registration@exlevents.com</p><p><b> </b></p><p align="center">“<b>Ply Emerging Technologies and Effective SOPs to Enhance Regulatory Compliance and the Quality of Your Safety System”</b></p><p>ExL Events is hosting the 4<sup>th</sup> Adverse Events Reporting and Safety Strategies Summit on December 4–5, 2017 at the Sonesta Philadelphia Rittenhouse Square in Philadelphia, PA.</p><p>This summit will offer an in-depth analysis of real-world data, case management, signal detection, inspections, solutions and artificial intelligence. Participants will return to work to ensure compliance and improve drug safety armed and informed by best practices, innovative solutions, leadership strategy and lessons learned of a <b>19-member illustrious speaking faculty</b>. <br /> <br />This participant-driven summit illustrates why it is the event of choice for AE and drug safety for insightful thought leaders, seasoned professionals and savvy leaders from the realm of PV. To view the full agenda, <a href="https://goo.gl/ipQ4Sc"><b>click here</b></a>.</p><p> </p><p><b><u>Featured Speakers:</u></b></p><h2><span class="font-size-2">· Deepa Arora</span><br /> <span class="font-size-2"><em>Vice President, Pharmacovigilance and Global Head, Drug Safety and Risk Management</em>, LUPIN LIMITED</span></h2><h2><span class="font-size-2">· Deanna Montes de Oca</span><br /> <span class="font-size-2"><em>Associate Director, PV Operations Clinical Safety and Pharmacovigilance</em>, OTSUKA</span></h2><h2><span class="font-size-2">· Michael von Forstner</span><br /> <span class="font-size-2"><em>Co-Chair, Pharmacovigilance Working Group</em>, MEDICINES FOR EUROPE</span></h2><h2><span class="font-size-2">· Andres Gomez</span><br /> <span class="font-size-2"><em>Vice President, Head of Epidemiology, Safety Science and Analytics</em>, BRISTOL-MYERS SQUIBB</span></h2><h2><span class="font-size-2">· Israel Gutierrez</span><br /> <span class="font-size-2"><em>Senior Director Drug Safety and Pharmacovigilance</em>, PHARMACYCLICS</span></h2><h2><span class="font-size-2">· Ghazala Haque</span><br /> <span class="font-size-2"><em>Safety Surveillance Manager</em>, DUKE UNIVERSITY MEDICAL CENTER</span></h2><h2><span class="font-size-2">· Judith Sills</span><br /> <span class="font-size-2"><em>Vice President and Head, Global Pharmacovigilance</em>, THE MEDICINES COMPANY</span></h2><h2><span class="font-size-2">· Gay Steinbrick</span><br /> <span class="font-size-2"><em>Director, Global Clinical Safety and Pharmacovigilance</em>, MERCK</span></h2><h2><span class="font-size-2">· Sameer Thapar</span><br /> <span class="font-size-2"><em>Assistant Professor and Advisor, Drug Safety and Pharmacovigilance</em>, RUTGERS UNIVERSITY</span></h2><h2><span class="font-size-2">· Susan Welsh</span><br /> <span class="font-size-2"><em>Chief Safety Officer</em>, CSL BEHRING</span></h2><p></p><p>To visit our conference website, please go to: <a href="https://goo.gl/REyLLY">https://goo.gl/REyLLY</a></p><p>To register, please go to <a href="https://goo.gl/BGq79V">https://goo.gl/BGq79V</a> and use <strong>Priority Code C900GRC.</strong></p><p> </p></div>