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Dendreon
Dendreon Pharmaceuticals LLC is a biotechnology company. Its lead product, Provenge (known generically as sipuleucel-T), is an immunotherapy for prostate cancer. It consists of a mixture of the patient's own blood cells (autologous, with dendritic cells thought to be the most important) that have been incubated with the Dendreon Prostatic acid phosphatase, PAP-GM-CSF fusion protein. Phase III clinical trial results demonstrating a survival benefit for prostate cancer patients receiving the drug were presented at the AUA meeting on April 28, 2009. After going through the approval process, Provenge was given full approval by the FDA on April 29, 2010. Dendreon's stock value fell 66% on August 4, 2011, after abandoning its forecast for its debut drug Provenge. In November 2014, Dendreon filed for Chapter 11 bankruptcy protection and shortly afterwards announced that it had reached agreements on the terms of a financial restructuring with certain bond holders. On February 20, 2015, ...
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Christopher Henney
Christopher Henney (born 1941) is an American immunologist and biotechnology entrepreneur who co-founded Immunex Corp. and Icos Corporation, and led Dendreon Corp. to the development of the first FDA-approved cancer vaccination therapy. Background Henney was born in 1941 in Birmingham, England. He was educated at Prince Albert School, King Edward VI School Aston, and at the University of Birmingham. Where he earned a B.Sc in 1962, a Ph.D in 1965, and was awarded a D.Sc. for his contributions to the field of immunology in 1972. After his postdoctoral studies at the University of Colorado School of Medicine and the Immunoglobulin Reference Centre in Lausanne, Switzerland, he was appointed to the faculty of Johns Hopkins University Medical School 972-1978 before taking the first chair of Basic Immunology at the Fred Hutchinson Cancer Center, Seattle in 1978. Henney, with Steven Gillis and Stephen Duzan co-founded Immunex Corporation in 1980. Immunex developed Leukine, an age ...
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Immunotherapy
Immunotherapy or biological therapy is the treatment of disease by activating or suppressing the immune system. Immunotherapies designed to elicit or amplify an immune response are classified as ''activation immunotherapies,'' while immunotherapies that reduce or suppress are classified as '' suppression immunotherapies''. Immunotherapy is under preliminary research for its potential to treat various forms of cancer. Cell-based immunotherapies are effective for some cancers. Immune effector cells such as lymphocytes, macrophages, dendritic cells, natural killer cells, and cytotoxic T lymphocytes work together to defend the body against cancer by targeting abnormal antigens expressed on the surface of tumor cells. Vaccine-induced immunity to COVID-19 relies mostly on an immunomodulatory T-cell response. Therapies such as granulocyte colony-stimulating factor (G-CSF), interferons, imiquimod and cellular membrane fractions from bacteria are licensed for medical use. Others in ...
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Valeant Pharmaceuticals
Bausch Health Companies Inc. is a global, diversified American-Canadian pharmaceutical company. Its global corporate headquarters are located in Laval, Quebec, Canada, and its U.S. headquarters are in Bridgewater, New Jersey. It develops, manufactures and markets a range of pharmaceutical products in gastroenterology, hepatology, neurology, dermatology, dentistry, medical aesthetics, and international pharmaceuticals. Bausch Health manufactures and markets branded pharmaceuticals, generic pharmaceuticals, and over-the-counter products directly or indirectly in more than 90 countries and regions, including the United States, Canada, Europe, the Middle East, Africa, Asia Pacific and Latin America. History 1959–2002: the Panić years In 1959, Milan Panić founded ICN Pharmaceuticals (International Chemical and Nuclear Corporation) in his Pasadena garage. Panić ran the company for 43 years, during which ICN established a foothold in the industry by acquiring niche pharmaceut ...
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Cancer Vaccines
A cancer vaccine, or oncovaccine, is a vaccine that either treats existing cancer or prevents development of cancer. Vaccines that treat existing cancer are known as ''therapeutic'' cancer vaccines or tumor antigen vaccines. Some of the vaccines are "autologous", being prepared from samples taken from the patient, and are specific to that patient. Some researchers claim that cancerous cells routinely arise and are destroyed by the immune system (Cancer immunoediting, immunosurveillance); and that tumors form when the immune system fails to destroy them. Some types of cancer, such as cervical cancer and liver cancer, are caused by viruses (oncoviruses). Traditional vaccines against those viruses, such as the HPV vaccine and the hepatitis B vaccine, prevent those types of cancer. Other cancers are to some extent caused by bacterial infections (e.g. stomach cancer and ''Helicobacter pylori''). Traditional vaccines against cancer-causing bacteria (Carcinogenic bacteria, oncobacteria ...
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Provenge
Sipuleucel-T, sold under the brand name Provenge, developed by Dendreon Pharmaceuticals, LLC, is a cell-based cancer immunotherapy for prostate cancer (CaP). It is an autologous cellular immunotherapy. Medical uses Sipuleucel-T is indicated for the treatment of metastatic, asymptomatic or minimally symptomatic, metastatic castrate-resistant hormone-refractory prostate cancer (HRPC). Other names for this stage are metastatic castrate-resistant (mCRPC) and androgen independent (AI) or (AIPC). This stage leads to mCRPC with lymph node involvement and distal (distant) tumors; this is the lethal stage of CaP. The prostate cancer staging designation is T4,N1,M1c. Treatment method A course of treatment consists of three basic steps: * The patient's white blood cells, primarily dendritic cells, a type of antigen-presenting cells (APCs), are extracted in a leukapheresis procedure. * The blood product is sent to a production facility and incubated with a fusion protein (PA2024) consi ...
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Electroporation
Electroporation, also known as electropermeabilization, is a microbiological and biotechnological technique in which an electric field is applied to cells to briefly increase the permeability of the cell membrane. The application of a high-voltage electric field induces a temporary destabilization of the lipid bilayer, resulting in the formation of nanoscale pores that permit the entry or exit of macromolecules. This method is widely employed to introduce molecules—including small molecules, DNA, RNA, and proteins—into cells. Electroporation can be performed on cells in suspension using electroporation cuvettes, or directly on adherent cells ''in situ'' within their culture vessels. In microbiology, electroporation is frequently utilized for the transformation of bacteria or yeast cells, often with plasmid DNA. It is also used in the transfection of plant protoplasts and mammalian cells. Notably, electroporation plays a critical role in the '' ex vivo'' manipulation ...
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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 ...
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Prostatic Acid Phosphatase
Prostatic acid phosphatase (PAP), also prostatic specific acid phosphatase (PSAP), is an enzyme produced by the prostate. It may be found in increased amounts in men who have prostate cancer or other diseases. The highest levels of acid phosphatase are found in metastasized prostate cancer. Diseases of the bone, such as Paget's disease or hyperparathyroidism, diseases of blood cells, such as sickle-cell disease or multiple myeloma or lysosomal storage diseases, such as Gaucher's disease, will show moderately increased levels. Certain medications can cause temporary increases or decreases in acid phosphatase levels. Manipulation of the prostate gland through massage, biopsy or rectal exam before a test may increase the level. Its physiological function may be associated with the liquefaction process of semen.Page 1135-1136 in: Use in prostatic cancer prognosis Serum marker PAP was used to monitor and assess progression of prostate cancer until the introduction of prostate sp ...
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Privately Held Company
A privately held company (or simply a private company) is a company whose Stock, shares and related rights or obligations are not offered for public subscription or publicly negotiated in their respective listed markets. Instead, the Private equity, company's stock is offered, owned, traded or exchanged privately, also known as "over-the-counter (finance), over-the-counter". Related terms are unlisted organisation, unquoted company and private equity. Private companies are often less well-known than their public company, publicly traded counterparts but still have major importance in the world's economy. For example, in 2008, the 441 list of largest private non-governmental companies by revenue, largest private companies in the United States accounted for $1.8 trillion in revenues and employed 6.2 million people, according to ''Forbes''. In general, all companies that are not owned by the government are classified as private enterprises. This definition encompasses both publ ...
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Morris Plains, New Jersey
Morris Plains is a borough in Morris County, in the U.S. state of New Jersey. As of the 2020 United States census, the borough's population was 6,153, an increase of 621 (+11.2%) from the 2010 census count of 5,532, which in turn reflected an increase of 296 (+5.7%) from the 5,236 counted in the 2000 census. Morris Plains was incorporated as a borough by an act of the New Jersey Legislature on March 15, 1926, from portions of Hanover Township, based on the results of a referendum held on April 15, 1926.Snyder, John P''The Story of New Jersey's Civil Boundaries: 1606-1968'' Bureau of Geology and Topography; Trenton, New Jersey; 1969. p. 195. Accessed May 30, 2024. The borough's name comes from Lewis Morris, colonial governor of New Jersey. Morris Plains serves as a bedroom community, with many residents traveling to work in New York City. The Morristown Line of NJ Transit provides commuters with direct access to New York Penn Station and to Hoboken Terminal. Geograp ...
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Fusion Protein
Fusion proteins or chimeric (kī-ˈmir-ik) proteins (literally, made of parts from different sources) are proteins created through the joining of two or more genes that originally coded for separate proteins. Translation of this '' fusion gene'' results in a single or multiple polypeptides with functional properties derived from each of the original proteins. ''Recombinant fusion proteins'' are created artificially by recombinant DNA technology for use in biological research or therapeutics. '' Chimeric'' or ''chimera'' usually designate hybrid proteins made of polypeptides having different functions or physico-chemical patterns. ''Chimeric mutant proteins'' occur naturally when a complex mutation, such as a chromosomal translocation, tandem duplication, or retrotransposition creates a novel coding sequence containing parts of the coding sequences from two different genes. Naturally occurring fusion proteins are commonly found in cancer cells, where they may function as oncop ...
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Food And Drug Administration (United States)
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs but involves other factors like regulating lasers, cellular phones, and condoms. In addition, the FDA takes control of disea ...
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