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LY-CoV555
Bamlanivimab is a monoclonal antibody developed by AbCellera Biologics and Eli Lilly and Company, Eli Lilly as a treatment for COVID-19. The medication was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in November 2020, and the EUA was revoked in April 2021. Bamlanivimab is an IgG1 monoclonal antibody (mAb) directed against the coronavirus spike protein, spike protein of SARS-CoV-2. The aim is to block viral attachment and entry into human cells, thus neutralizing the virus, and help preventing and treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to COVID-19 drug development, create antibody therapies for the prevention and treatment of COVID-19. Bamlanivimab is also used as part of the bamlanivimab/etesevimab combination that was granted an EUA by the FDA. In June 2021, the US Office of the Assistant Secretary for Preparedness and Response (ASPR) paused distribution of bamlanivimab and etese ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 anti ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
AbCellera Biologics
AbCellera Biologics Inc. is a Vancouver, British Columbia-based biotechnology firm that researches and develops human antibodies. The company is best known for its leading role in the Pandemic Prevention Platform, a project of DARPA's Biological Technologies Office. AbCellera utilizes a proprietary technology platform, which they claim can develop "medical countermeasures within 60 days." Its platform for single-cell screening was initially developed at the University of British Columbia. History AbCellera was founded in 2012 by biomedical researchers Carl Hansen, Véronique Lecault, Kevin Heyries, Daniel Da Costa and Oleh Petriv. In November 2016, the company received a 645K grant from the Bill & Melinda Gates Foundation to develop a test for tuberculosis. In September 2018, a $10M series A round of funding was closed. In May 2020, a $105M series B round of funding was closed. In January 2017, AbCellera announced that it would be collaborating with Pfizer to discover and de ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Eli Lilly And Company
Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries. Its products are sold in approximately 125 countries. The company was founded in 1876 by, and named after, Colonel Eli Lilly, a pharmaceutical chemist and veteran of the American Civil War. As of 2022, Lilly is known for its clinical depression drugs Prozac ( fluoxetine) (1986) and Cymbalta (duloxetine) (2004) and its antipsychotic medication Zyprexa (olanzapine) (1996), although its primary revenue drivers are the diabetes drugs Humalog (insulin lispro) (1996) and Trulicity (dulaglutide) (2014). Lilly's achievements include being the first company to mass-produce the polio vaccine developed by Jonas Salk, and insulin. It was one of the first pharmaceutical companies to produce human insulin using recombinant DNA including Humulin ( insulin medication), Humalog (insulin lispro), and the first approved biosimilar insulin product in the US, Basaglar ( ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
AbCellera
AbCellera Biologics Inc. is a Vancouver, British Columbia-based biotechnology firm that researches and develops human antibodies. The company is best known for its leading role in the Pandemic Prevention Platform, a project of DARPA's Biological Technologies Office. AbCellera utilizes a proprietary technology platform, which they claim can develop "medical countermeasures within 60 days." Its platform for single-cell screening was initially developed at the University of British Columbia. History AbCellera was founded in 2012 by biomedical researchers Carl Hansen, Véronique Lecault, Kevin Heyries, Daniel Da Costa and Oleh Petriv. In November 2016, the company received a 645K grant from the Bill & Melinda Gates Foundation to develop a test for tuberculosis. In September 2018, a $10M series A round of funding was closed. In May 2020, a $105M series B round of funding was closed. In January 2017, AbCellera announced that it would be collaborating with Pfizer to discover and de ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Antiviral Drugs
Antiviral drugs are a class of medication used for treating viral infections. Most antivirals target specific viruses, while a broad-spectrum antiviral is effective against a wide range of viruses. Unlike most antibiotics, antiviral drugs do not destroy their target pathogen; instead they inhibit its development. Antiviral drugs are one class of antimicrobials, a larger group which also includes antibiotic (also termed antibacterial), antifungal and antiparasitic drugs, or antiviral drugs based on monoclonal antibodies. Most antivirals are considered relatively harmless to the host, and therefore can be used to treat infections. They should be distinguished from viricides, which are not medication but deactivate or destroy virus particles, either inside or outside the body. Natural viricides are produced by some plants such as eucalyptus and Australian tea trees. Medical uses Most of the antiviral drugs now available are designed to help deal with HIV, herpes viruses, the h ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Emergency Use Authorization
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Act of Congress, Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by , to allow the use of a drug prior to approved drug, approval. It does not constitute ''approval'' of the drug in the full statutory meaning of the term, but instead authorizes the FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security. Use EUAs have historically been infrequent. A review article by Rizk et al. provides a summary of the US experience in 2020 with pharmacological EUA approvals during the COVID-19 pandemic. It also provides a descripti ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Operation Warp Speed
Operation Warp Speed (OWS) was a public–private partnership initiated by the United States government to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The first news report of Operation Warp Speed was on April 29, 2020, and the program was officially announced on May 15, 2020. It was headed by Moncef Slaoui from May 2020 to January 2021 and by David A. Kessler from January to February 2021. At the end of February 2021, Operation Warp Speed was transferred into the responsibilities of the White House COVID-19 Response Team. The program promoted mass production of multiple vaccines, and different types of vaccine technologies, based on preliminary evidence, allowing for faster distribution if clinical trials confirm one of the vaccines is safe and effective. The plan anticipated that some of these vaccines will not prove safe or effective, making the program more costly than typical vaccine develo ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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