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Evolocumab
Evolocumab, sold under the brand name Repatha, is a monoclonal antibody that is an immunotherapy medication for the treatment of hyperlipidemia. Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that targets LDL receptors for degradation; its inhibition thereby enhances the liver's ability to remove LDL-C, often colloquially referred to as "bad" cholesterol, from the blood. Mechanism Evolocumab is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface. In the absence of PCSK9, there are more LDL receptors on the surface of liver cells to remove LDL-C from the blood. Adverse effects Injection site reactions such as redness and pain are common and are reported in approximately 2.1–4.3% of cases. A reanalysis of the FOURIER trial based on regulatory data found that cardiac mortality with evolocumab was slightly higher than previously reported, however, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
PCSK9
Proprotein convertase subtilisin/kexin type 9 (PCSK9) is an enzyme encoded by the ''PCSK9'' gene in humans on chromosome 1. It is the 9th member of the proprotein convertase family of proteins that activate other proteins. Similar genes ( orthologs) are found across many species. As with many proteins, PCSK9 is inactive when first synthesized, because a section of peptide chains blocks their activity; proprotein convertases remove that section to activate the enzyme. The ''PCSK9'' gene also contains one of 27 loci associated with increased risk of coronary artery disease. PCSK9 is ubiquitously expressed in many tissues and cell types. PCSK9 binds to and degrades the receptor for low-density lipoprotein particles (LDL), which typically transport 3,000 to 6,000 fat molecules (including cholesterol) per particle, within extracellular fluid. The LDL receptor (LDLR), on liver and other cell membranes, binds and initiates ingestion of LDL-particles from extracellular fluid into cel ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
PCSK9 Inhibitors
Proprotein convertase subtilisin/kexin type 9 (PCSK9) is an enzyme encoded by the ''PCSK9'' gene in humans on chromosome 1. It is the 9th member of the proprotein convertase family of proteins that activate other proteins. Similar genes (orthologs) are found across many species. As with many proteins, PCSK9 is inactive when first synthesized, because a section of peptide chains blocks their activity; proprotein convertases remove that section to activate the enzyme. The ''PCSK9'' gene also contains one of 27 loci associated with increased risk of coronary artery disease. PCSK9 is ubiquitously expressed in many tissues and cell types. PCSK9 binds to and degrades the receptor for low-density lipoprotein particles (LDL), which typically transport 3,000 to 6,000 fat molecules (including cholesterol) per particle, within extracellular fluid. The LDL receptor (LDLR), on liver and other cell membranes, binds and initiates ingestion of LDL-particles from extracellular fluid into cells ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Alirocumab
Alirocumab, sold under the brand name Praluent, is a medication used as a second-line treatment for high cholesterol for adults whose cholesterol is not controlled by diet and statin treatment. It is a human monoclonal antibody that belongs to a novel class of anti-cholesterol drugs, known as PCSK9 inhibitors, and it was the first such agent to receive FDA approval. The FDA approval was contingent on the completion of further clinical trials to better determine efficacy and safety. Common side effects include nasopharyngitis (cold), injection site reactions, and influenza. It was approved for medical use in the United States and in the European Union in 2015. Medical uses Alirocumab is used as a second-line treatment to lower LDL cholesterol for adults who have a severe form of hereditary high cholesterol and people with atherosclerosis who require additional lowering of LDL cholesterol when diet and statin treatment have not worked. It is administered by subcutaneous inje ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Amgen
Amgen Inc. (formerly Applied Molecular Genetics Inc.) is an American multinational biopharmaceutical Corporation, company headquartered in Thousand Oaks, California. As one of the world's largest independent biotechnology companies, Amgen has approximately 24,000 staff in total as of 2022. The name "AMGen" is a portmanteau of the company's original name, Applied Molecular Genetics, which became the official name of the company in 1983 (three years after incorporation and coincident with its initial public offering). The company is listed on the Nasdaq Global Select Market under the ticker symbol "AMGN", as well as a component of the Nasdaq-100, the Dow Jones Industrial Average, and the S&P 100 and S&P 500, 500 indices. History Amgen was established in Thousand Oaks in 1980, as Applied Molecular Genetics.Baker, Pam (2002). ''Thousand Oaks Westlake Village: A Contemporary Portrait''. Community Communications, Inc., p. 37. . Amgen was backed by a small group of venture capital ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Injunction
An injunction is an equitable remedy in the form of a special court order compelling a party to do or refrain from doing certain acts. It was developed by the English courts of equity but its origins go back to Roman law and the equitable remedy of the "interdict". "When a court employs the extraordinary remedy of injunction, it directs the conduct of a party, and does so with the backing of its full coercive powers."'' Nken v. Holder''556 U.S. 418, 428 (2009) (citation and internal quotation marks omitted). A party that fails to comply with an injunction faces criminal or civil penalties, including possible monetary sanctions and even imprisonment. They can also be charged with contempt of court. Rationale The injunction is an equitable remedy that was created by the English courts of equity. Like other equitable remedies, it has traditionally been given when a wrong cannot be effectively remedied by an award of money damages. (The doctrine that reflects this is the req ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality-adjusted Life Year
The quality-adjusted life year (QALY) is a generic measure of disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the value of medical interventions. One QALY equates to one year in perfect health. QALY scores range from 1 (perfect health) to 0 (dead). QALYs can be used to inform health insurance coverage determinations, treatment decisions, to evaluate programs, and to set priorities for future programs. Critics argue that the QALY oversimplifies how actual patients would assess risks and outcomes, and that its use may restrict patients with disabilities from accessing treatment. Proponents of the measure acknowledge that the QALY has some shortcomings, but that its ability to quantify tradeoffs and opportunity costs from the patient, and societal perspective make it a critical tool for equitably allocating resources. Calculation A measure of the state of health of a person or group in which the benefits, in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceuticals
Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. Drugs are classified in many ways. One of the key divisions is by level of control, which distinguishes prescription drugs (those that a pharmacist dispenses only on the medical prescription) from over-the-counter drugs (those that consumers can order for themselves). Medicines may be classified by mode of action, route of administration, biological system affected, or therapeutic effects. The World Health Organization keeps a list of essential medicines. Drug discovery and drug development are complex and expensive endeavors undertaken by pharmaceutical companies, academic scientists, and governments. As a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biologics
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biopharmaceuticals can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. The term biologics is often used more restric ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Purposivism
The purposive approach (sometimes referred to as purposivism, purposive construction, purposive interpretation, or the modern principle in construction) is an approach to statutory and constitutional interpretation under which common law courts interpret an enactment (a statute, part of a statute, or a clause of a constitution) within the context of the law's purpose. Purposive interpretation is a derivation of mischief rule set in '' Heydon's Case'', and intended to replace the mischief rule, the plain meaning rule and the golden rule. Purposive interpretation is used when the courts use extraneous materials from the pre-enactment phase of legislation, including early drafts, hansards, committee reports, and white papers. Israeli jurist Aharon Barak views purposive interpretation as a legal construction that combines subjective and objective elements.Barak, Aharon. ''Purposive Interpretation In Law''. Princeton University Press (New Jersey), 2005, p. 88 Barak states that the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Sufficiency Of Disclosure
Sufficiency of disclosure or enablement is a patent law requirement that a patent application disclose a claim (patent), claimed invention in sufficient detail so that the person skilled in the art could carry out that claimed invention. The requirement is fundamental to patent law: a monopoly is granted for a term of patent, given period of time in exchange for a disclosure to the public how to make or practice the invention. Background The disclosure requirement lies at the heart and origin of patent law. An inventor, or the inventor's Assignment (law), assignee, is granted a monopoly for a given period of time in exchange for the inventor disclosing to the public how to make or practice their invention. If a patent fails to contain such information, then the bargain is violated, and the patent is unenforceable or can be revoked. Inventors who do not wish to teach the world about their invention still have some protection under trade secret law, which protects valuable secrets ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Antigen
In immunology, an antigen (Ag) is a molecule, moiety, foreign particulate matter, or an allergen, such as pollen, that can bind to a specific antibody or T-cell receptor. The presence of antigens in the body may trigger an immune response. Antigens can be proteins, peptides (amino acid chains), polysaccharides (chains of simple sugars), lipids, or nucleic acids. Antigens exist on normal cells, cancer cells, parasites, viruses, fungus, fungi, and bacteria. Antigens are recognized by antigen receptors, including antibodies and T-cell receptors. Diverse antigen receptors are made by cells of the immune system so that each cell has a specificity for a single antigen. Upon exposure to an antigen, only the lymphocytes that recognize that antigen are activated and expanded, a process known as clonal selection. In most cases, antibodies are ''antigen-specific'', meaning that an antibody can only react to and bind one specific antigen; in some instances, however, antibodies may cr ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Epitope
An epitope, also known as antigenic determinant, is the part of an antigen that is recognized by the immune system, specifically by antibodies, B cells, or T cells. The part of an antibody that binds to the epitope is called a paratope. Although epitopes are usually non-self proteins, sequences derived from the host that can be recognized (as in the case of autoimmune diseases) are also epitopes. The epitopes of protein antigens are divided into two categories, conformational epitopes and linear epitopes, based on their structure and interaction with the paratope. Conformational and linear epitopes interact with the paratope based on the 3-D conformation adopted by the epitope, which is determined by the surface features of the involved epitope residues and the shape or tertiary structure of other segments of the antigen. A conformational epitope is formed by the 3-D conformation adopted by the interaction of discontiguous amino acid residues. In contrast, a linear epitope i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
