Casirivimab
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Casirivimab
Casirivimab/imdevimab, sold under the brand name REGEN‑COV among others, Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. is a combination medicine used for the treatment and prevention of COVID19. It consists of two human monoclonal antibodies, casirivimab and imdevimab that must be mixed together and administered as an infusion or subcutaneous injection. The combination of two antibodies is intended to prevent mutational escape. It is also available as a co-formulated product. It was developed by the American biotechnology company Regeneron Pharmaceuticals. The most common side effects include allergic reactions, which include infusion related reactions, injection site reactions, brief pain, weakness and others. The combination is approved under the brand name Ronapreve for medical use in Japan, the United Kingdom, the European Union, and Australia. In January 2022, the U.S. F ...
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Monoclonal Antibody
A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodies can have monovalent affinity, binding only to the same epitope (the part of an antigen that is recognized by the antibody). In contrast, polyclonal antibodies bind to multiple epitopes and are usually made by several different antibody-secreting plasma cell lineages. Bispecific monoclonal antibodies can also be engineered, by increasing the therapeutic targets of one monoclonal antibody to two epitopes. It is possible to produce monoclonal antibodies that specifically bind to virtually any suitable substance; they can then serve to detect or purify it. This capability has become an investigative tool in biochemistry, molecular biology, and medicine. Monoclonal antibodies are being used on a clinical level for both the diagnosis and therapy ...
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Bamlanivimab/etesevimab
Bamlanivimab/etesevimab is a combination of two monoclonal antibodies, bamlanivimab and etesevimab, administered together via intravenous infusion as a treatment for COVID-19. Both types of antibody target the surface spike protein of SARS‑CoV‑2. Bamlanivimab and etesevimab, administered together, are authorized in the United States for the treatment of mild-to-moderate COVID-19 in people aged twelve years of age and older weighing at least with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. They are also authorized, when administered together, for use after exposure to the SARS-CoV-2 virus for post-exposure prophylaxis (PEP) for COVID-19 and are not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus. In January 2022, the U.S. Food and Drug Administration (FDA) revised the authorizations for two monoclonal antibody ...
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Human Monoclonal Antibodies
A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodies can have monovalent affinity, binding only to the same epitope (the part of an antigen that is recognized by the antibody). In contrast, polyclonal antibodies bind to multiple epitopes and are usually made by several different antibody-secreting plasma cell lineages. Bispecific monoclonal antibodies can also be engineered, by increasing the therapeutic targets of one monoclonal antibody to two epitopes. It is possible to produce monoclonal antibodies that specifically bind to virtually any suitable substance; they can then serve to detect or purify it. This capability has become an investigative tool in biochemistry, molecular biology, and medicine. Monoclonal antibodies are being used on a clinical level for both the diagnosis and therapy o ...
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Coronavirus Spike Protein
Spike (S) glycoprotein (sometimes also called spike protein, formerly known as E2) is the largest of the four major structural proteins found in coronaviruses. The spike protein assembles into trimers that form large structures, called spikes or peplomers, that project from the surface of the virion. The distinctive appearance of these spikes when visualized using negative stain transmission electron microscopy, "recalling the solar corona", gives the virus family its name. The function of the spike glycoprotein is to mediate viral entry into the host cell by first interacting with molecules on the exterior cell surface and then fusing the viral and cellular membranes. Spike glycoprotein is a class I fusion protein that contains two regions, known as S1 and S2, responsible for these two functions. The S1 region contains the receptor-binding domain that binds to receptors on the cell surface. Coronaviruses use a very diverse range of receptors; SARS-CoV (which causes SARS) an ...
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SARS-CoV-2 Omicron Variant
Omicron (B.1.1.529) is a variant of SARS-CoV-2 first reported to the World Health Organization (WHO) by the Network for Genomics Surveillance in South Africa on 24 November 2021. It was first detected in Botswana and has spread to become the predominant variant in circulation around the world. Following the original BA.1 variant, several subvariants of Omicron have emerged: BA.2, BA.3, BA.4, and BA.5. Since October 2022, two subvariants of BA.5 named BQ.1 and BQ.1.1 have spread rapidly. Three doses of a COVID-19 vaccine provide protection against severe disease and hospitalisation caused by BA.1 and BA.2. The immunity effects of BA.2 are similar to those of BA.1. For three-dose vaccinated individuals, the BA.4 and BA.5 variants are more infectious than previous subvariants, making it likely, , for a new peak in COVID-19 infections to occur. __TOC__ Classification On 26 November, the WHO's Technical Advisory Group on SARS-CoV-2 Virus Evolution declared PANGO linea ...
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European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would not onl ...
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Committee For Medicinal Products For Human Use
The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding medicinal products for human use. See also * Committee for Medicinal Products for Veterinary Use The Committee for Medicinal Products for Veterinary Use (CVMP) is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding veterinary medicines. Text was copied from this source which is © ... References External links Committee for Medicinal Products for Human Use (CHMP) Health and the European Union {{eu-stub ...
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Unitaid
Unitaid is a global health initiative that works with partners to bring about innovations to prevent, diagnose and treat major diseases in low- and middle-income countries, with an emphasis on tuberculosis, malaria, and HIV/AIDS and its deadly co-infections. Founded in 2006, the organization funds the final stages of research and development of new drugs, diagnostics and disease-prevention tools, helps produce data supporting guidelines for their use, and works to allow more affordable generic medicines to enter the marketplace in low- and middle-income countries. Hosted by the World Health Organization (WHO) in Geneva, Unitaid was established by the governments of Brazil, Chile, France, Norway and the United Kingdom. As of 2019, Unitaid manages a portfolio of 48 grants worth around US$1.3 billion. More than half of Unitaid's projects contribute to the global fight against antimicrobial resistance. Unitaid supports programs that are implemented by organizations such as Coalition ...
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Greg Abbott
Gregory Wayne Abbott (born November 13, 1957) is an American politician, attorney, and former jurist serving as the 48th governor of Texas since 2015. A member of the Republican Party (United States), Republican Party, he served as the 50th Texas Attorney General, attorney general of Texas from 2002 to 2015 and as a member of the Texas Supreme Court from 1996 to 2001. Abbott was the third Republican to serve as attorney general of Texas since the Reconstruction era, Reconstruction era. He was elected to that office with 57% of the vote in 2002 and reelected with 60% in 2006 and 64% in 2010, becoming the longest-serving Texas attorney general in state history, with 12 years of service. Before becoming attorney general, Abbott was a justice of the Supreme Court of Texas, Texas Supreme Court, a position to which he was appointed in 1995 by then-governor George W. Bush. Abbott won a full term in 1998 with 60% of the vote. As attorney general, he successfully advocated for the Texas ...
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Hoffmann-La Roche
F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel. Roche is the fifth largest pharmaceutical company in the world by revenue, and the leading provider of cancer treatments globally. The company controls the American biotechnology company Genentech, which is a wholly owned affiliate, and the Japanese biotechnology company Chugai Pharmaceuticals, as well as the United States-based companies Ventana and Foundation Medicine. Roche's revenues during fiscal year 2020 were 58.32 billion Swiss francs. Descendants of the founding Hoffmann and Oeri families own slightly over half of the bearer shares with voting rights (a pool of family shareholders 45%, and Maja Oeri a further 5% apart), with Swiss pharma firm Novartis owning a furth ...
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Compassionate Use
Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. These programs go under various names, including early access, special access, or managed access program, compassionate use, compassionate access, named-patient access, temporary authorization for use, cohort access, and pre-approval access. In general the person and their doctor must apply for access to the investigational product, the company has to choose to cooperate, and the medicines regulatory agency needs to agree that the risks and possible benefits of the drug or device are understood well enough to determine if putting the person at risk has sufficient potential benefit. In some countries the government will pay for the drug or ...
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