Romosozumab
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Romosozumab
Romosozumab, sold under the brand name Evenity, is a medication used to treat osteoporosis. It has been found to decrease the risk of fractures of the spine. Common side effect include headache, joint pain, and pain at the site of injection. It may increase the risk of heart attacks, strokes, and deaths from cardiovascular disease. It is a humanized monoclonal antibody that targets sclerostin. Research shows the drug increases bone formation and decreases bone resorption in postmenopausal women with low bone density. Romosozumab was approved for medical use in Japan, the United States and the European Union in 2019. The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. Medical uses Romosozumab is used for osteoporosis to decrease the risk of fractures. Two trials found that it reduced the rate of vertebral fracture. In one, there was a 73% lower risk of vertebral fracture after one year, and the benefit was maintained after a second yea ...
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Sclerostin
Sclerostin is a protein that in humans is encoded by the ''SOST'' gene. Sclerostin is a secreted glycoprotein with a C-terminal cysteine knot-like (CTCK) domain and sequence similarity to the DAN (differential screening-selected gene aberrative in neuroblastoma) family of bone morphogenetic protein (BMP) antagonists. Sclerostin is produced primarily by the osteocyte but is also expressed in other tissues, and has anti-anabolic effects on bone formation. Structure The sclerostin protein, with a length of 213 residues, has a secondary structure that has been determined by protein NMR to be 28% beta sheet (6 strands; 32 residues). Function Sclerostin, the product of the SOST gene, located on chromosome 17q12–q21 in humans, was originally believed to be a non-classical bone morphogenetic protein (BMP) antagonist. More recently, sclerostin has been identified as binding to LRP5/ 6 receptors and inhibiting the Wnt signaling pathway. The inhibition of the Wnt pathway leads to ...
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Sclerostin
Sclerostin is a protein that in humans is encoded by the ''SOST'' gene. Sclerostin is a secreted glycoprotein with a C-terminal cysteine knot-like (CTCK) domain and sequence similarity to the DAN (differential screening-selected gene aberrative in neuroblastoma) family of bone morphogenetic protein (BMP) antagonists. Sclerostin is produced primarily by the osteocyte but is also expressed in other tissues, and has anti-anabolic effects on bone formation. Structure The sclerostin protein, with a length of 213 residues, has a secondary structure that has been determined by protein NMR to be 28% beta sheet (6 strands; 32 residues). Function Sclerostin, the product of the SOST gene, located on chromosome 17q12–q21 in humans, was originally believed to be a non-classical bone morphogenetic protein (BMP) antagonist. More recently, sclerostin has been identified as binding to LRP5/ 6 receptors and inhibiting the Wnt signaling pathway. The inhibition of the Wnt pathway leads to ...
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Osteoporosis
Osteoporosis is a systemic skeletal disorder characterized by low bone mass, micro-architectural deterioration of bone tissue leading to bone fragility, and consequent increase in fracture risk. It is the most common reason for a broken bone among the elderly. Bones that commonly break include the vertebrae in the spine, the bones of the forearm, and the hip. Until a broken bone occurs there are typically no symptoms. Bones may weaken to such a degree that a break may occur with minor stress or spontaneously. After the broken bone heals, the person may have chronic pain and a decreased ability to carry out normal activities. Osteoporosis may be due to lower-than-normal maximum bone mass and greater-than-normal bone loss. Bone loss increases after the menopause due to lower levels of estrogen, and after ' andropause' due to lower levels of testosterone. Osteoporosis may also occur due to a number of diseases or treatments, including alcoholism, anorexia, hyperthyroidism, ...
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First-in-class Medication
A first-in-class medication is a pharmaceutical that uses a "new and unique mechanism of action" to treat a particular medical condition. While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medications and reports on them annually, first-in-class is not considered a regulatory category. Although many first-in-class medications qualify as breakthrough therapies, Regenerative Medicine Advanced Therapies and/or orphan drugs, first-in-class status itself has no regulatory effect. Examples Controversy Safety By definition, a first-in-class drug does not have the safety evidence from analogous products that not-first-in-class drugs would have. However, a study investigating recalls and warnings in relation to first-in-class drugs approved between 1997 and 2012 by Health Canada has found that first-in-class drugs actually have a more favourable benefit-to-harm ratio. Economics First-in-class drugs are often seen as commerci ...
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Chiroscience
Chiroscience Group Plc was a British-based biotech company, founded by Christopher Evans. The company was taken over by Celltech in 1999, which was acquired in 2004 by UCB. History Chiroscience was born from the demise of the company Enzymatix, which was ultimately acquired by Genzyme, when Andrew Richards joined the company and convinced Evans and Peter Keen to launch Chiros, which name was quickly revised to Chrioscience. Seed funding for the company of was provided by Schroder Ventures, Apax and 3i. Chiroscience became one of the first biotechnology Initial Public Offerings in the United Kingdom in 1994. In 1996, the company merged with the American biotech company ''Darwin Molecular Corporation'', based in Cambridge, Massachusetts, retaining Chiroscience as its name. By the time of its merger with Celltech in 1999, both Chris Evans and Peter Keen had left the company, leaving Andrew Richards as the sole remaining founder and member of the original management board. ...
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Amgen
Amgen Inc. (formerly Applied Molecular Genetics Inc.) is an American multinational biopharmaceutical Corporation, company headquartered in Thousand Oaks, California. One of the world's largest independent biotechnology companies, Amgen was established in Thousand Oaks, California, in 1980.Baker, Pam (2002). ''Thousand Oaks Westlake Village: A Contemporary Portrait''. Community Communications, Inc. Page 37. . Amgen's Thousand Oaks staff in 2017 numbered 5,125 (7.5% of total city employment) and included hundreds of scientists, making Amgen the largest employer in Ventura County, California, Ventura County. Focused on molecular biology and biochemistry, its goal is to provide a healthcare business based on recombinant DNA technology. In 2018, the company's largest selling product lines were Neulasta, an immunostimulator used to prevent infections in patients undergoing cancer chemotherapy and Enbrel, a tumor necrosis factor blocker used in the treatment of rheumatoid arthritis and ...
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UCB (company)
UCB (Union Chimique Belge) is a multinational biopharmaceutical company headquartered in Brussels, Belgium. UCB is an international company with revenue of €4.178 billion in 2016 which focuses primarily on research and development, specifically involving medications centered on epilepsy, Parkinson's disease, and Crohn's disease. The company's efforts are focused on treatments for severe diseases treated by specialists, particularly in the fields of central nervous system (CNS) disorders (including epilepsy), inflammatory disorders (including allergy), and oncology. Every three years, the company presents the UCB Award under the patronage of the Queen Elisabeth Medical Foundation to promote neuroscience research. The winner of this award is selected by an independent scientific committee. History UCB was founded on 18 January 1928 by Emmanuel Janssen, a Belgian businessman. Initially focused on industrial chemicals (it was one of the first companies to distill ammonia fro ...
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Celltech
Celltech Group plc was a leading British-based biotechnology business based in Slough. It was listed on the London Stock Exchange and was a constituent of the FTSE 100 Index. History Celltech was founded by Gerard Fairtlough in 1980 with finance from the National Enterprise Board. Amongst the work conducted at Celltech was the cloning of the glutamine synthetase (GS) gene in CHO cells leading to the creation of a biotechnology tool still widely used to express recombinant eukaryotic proteins. In 1999 Celltech led consolidation in the UK biosciences market merging with ''Chiroscience plc'', after which it was briefly referred to as ''Celltech Chiroscience,'' and then buying ''Medeva plc''. Then in 2000 it bought ''Cistron'', a US biosciences business. It expanded into Germany in 2001 buying Thiemann, a German biosciences business, and went on to buy Oxford Glycosciences in July 2003 for £102m. Celltech was acquired by UCB, a Belgian drugmaker, in 2004. Since then it has bee ...
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Boxed Warning
In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears on the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text. The FDA can require a pharmaceutical company to place a boxed warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. Economists and physicians have thoroughly studied the effects of FDA boxed warnings on prescription patterns. It is not necessarily true that a physician and patient will have a conversation about a drug's boxed warning after it is issued. For instance, an FDA-mandated boxed warning decreased rosiglitazone use by 70%, but that still meant 3.8 million people we ...
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Alendronate
Alendronic acid, sold under the brand name Fosamax among others, is a bisphosphonate medication used to treat osteoporosis and Paget's disease of bone. It is taken by mouth. Use is often recommended together with vitamin D, calcium supplementation, and lifestyle changes. Common side effects (1 to 10% of patients) include constipation, abdominal pain, nausea, and acid reflux. Use is not recommended during pregnancy or in those with poor kidney function. Alendronic acid works by decreasing the activity of cells that break down bone. Alendronic acid was first described in 1978 and approved for medical use in the United States in 1995. It is available as a generic medication. In 2020, it was the 94th most commonly prescribed medication in the United States, with more than 7million prescriptions. Medical uses * Prevention and treatment of female osteoporosis * Treatment of male osteoporosis * Prevention and treatment of corticosteroid-associated osteoporosis together with supplem ...
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American Medical Association
The American Medical Association (AMA) is a professional association and lobbying group of physicians and medical students. Founded in 1847, it is headquartered in Chicago, Illinois. Membership was approximately 240,000 in 2016. The AMA's stated mission is "to promote the art and science of medicine and the betterment of public health." The Association also publishes the ''Journal of the American Medical Association'' (JAMA). The AMA also publishes a list of Physician Specialty Codes which are the standard method in the U.S. for identifying physician and practice specialties. The American Medical Association is governed by a House of Delegates as well as a board of trustees in addition to executive management. The organization maintains the AMA Code of Medical Ethics, and the AMA Physician Masterfile containing data on United States Physicians. The ''Current Procedural Terminology'' coding system was first published in 1966 and is maintained by the Association. It has also publi ...
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Denosumab
Denosumab (trade names Prolia and Xgeva) is a human monoclonal antibody for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone. Denosumab is contraindicated in people with low blood calcium levels. The most common side effects are joint and muscle pain in the arms or legs. Denosumab is a inhibitor of RANKL (receptor activator of nuclear factor kappa-Β ligand), which works by preventing the development of osteoclasts, which are cells that break down bone. It was developed by the biotechnology company Amgen. Medical uses Denosumab is used for those with osteoporosis at high risk for fractures, bone loss due to certain medications, and in those with bone metastases. Cancer A 2012 meta-analysis found that denosumab was better than placebo, zoledronic acid and pamidronate, in reducing the risk of fractures in those with cancer. Osteoporosis In those with postmenopausal osteoporosis denosumab decreases the risk of fracture ...
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