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Cangene
Cangene Corporation was a biopharmaceutical company based in Winnipeg, Manitoba, Canada. It was founded in 1984 and specialized in hyperimmunes, contract manufacturing, biopharmaceuticals and biodefense. Cangene was 61% owned by Canadian pharmaceutical giant Apotex and was publicly listed on the TSX under the symbol CNJ. Business model Cangene's business model shifted several times during its existence. There is some consensus that the company came to rely on revenue from United States stockpiling and bioterrorism contracts and did not adequately prepare for the disappearance of this revenue. At one point, the company attempted a shift away from contract manufacturing to research & development, but abandoned this track after about two years and subsequently moved to marketing of ready-for-launch products developed by other companies. History Cangene was founded in 1984 and had an employee count of 650 in 2004. In 2009, the number of personnel in the Winnipeg facilities alone w ...
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Cangene BioPharma
Cangene Corporation was a biopharmaceutical company based in Winnipeg, Manitoba, Canada. It was founded in 1984 and specialized in hyperimmunes, contract manufacturing, biopharmaceuticals and biodefense. Cangene was 61% owned by Canadian pharmaceutical giant Apotex and was publicly listed on the TSX under the symbol CNJ. Business model Cangene's business model shifted several times during its existence. There is some consensus that the company came to rely on revenue from United States stockpiling and bioterrorism contracts and did not adequately prepare for the disappearance of this revenue. At one point, the company attempted a shift away from contract manufacturing to research & development, but abandoned this track after about two years and subsequently moved to marketing of ready-for-launch products developed by other companies. History Cangene was founded in 1984 and had an employee count of 650 in 2004. In 2009, the number of personnel in the Winnipeg facilities alone w ...
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Heptavalent Botulism Antitoxin
The Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) – BAT, made by Emergent BioSolutions Canada Inc. (formerly Cangene Corporation) – is a licensed, commercially available botulism anti-toxin that effectively neutralizes all seven known botulinum nerve toxin serotypes (types A, B, C, D, E, F and G). It is indicated for sporadic cases of life-threatening botulism and is also stockpiled for the eventuality of botulinum nerve toxins being used in a future bioterrorist attack. BAT was first approved in 2010 by the Centers for Disease Control for the indication of treating naturally occurring non-infant botulism on an investigational basis, replacing two earlier products. It was then licensed for commercial marketing by the United States FDA in 2013. History Development and domestic contracts BAT (formerly known as HBAT) was developed from equine (horse) plasma at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). The main funding strea ...
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Apotex
Apotex Inc. is a Canadian pharmaceutical corporation. Founded in 1974 by Barry Sherman, the company is the largest producer of generic drugs in Canada, with annual sales exceeding . By 2016, Apotex employed over 10,000 people as one of Canada's largest drug manufacturers, with over 300 products selling in over 115 countries. Revenues were about CA$1.19 billion annually. Apotex manufactures and distributes generic medications for a range of diseases and health conditions that include cancer, diabetes, high cholesterol, glaucoma, infections and blood pressure. Apotex is a member of the Canadian Generic Pharmaceutical Association (CGPA), the Generic Pharmaceutical Association (GPhA), an associate member of the Canadian Animal Health Institute (CAHI), the Canadian Association for Pharmacy Distribution Management (CAPDM), as well as the Greater Toronto Area's Partners in Project Green. History Apotex began with limited staff in a 5,000-square-foot warehouse. When Barry Sherman started ...
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Emergent BioSolutions
Emergent BioSolutions Inc. is an American multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland. It develops vaccines and antibody therapeutics for infectious diseases and opioid overdoses, and it provides medical devices for biodefense purposes. Among the company's products are the controversial BioThrax (Anthrax Vaccine Adsorbed), the only anthrax vaccine licensed by the U.S. Food and Drug Administration (FDA) and Narcan (naloxone) for the emergency treatment of opioid overdose. The company also manufactures pharmaceuticals for infectious diseases like cholera and typhoid. During the COVID-19 pandemic, Emergent BioSolutions also produced Johnson & Johnson and AstraZeneca/Oxford vaccines at one of its plants; however, this was marked by contamination and other production issues, and millions of doses of vaccine had to be discarded. Company history Early history Emergent BioSolutions was founded on September 5, 1998, by Fuad El-Hibri, un ...
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Vaccinia Immune Globulin
Vaccinia immune globulin (VIG) is made from the pooled blood of individuals who have been inoculated with the smallpox vaccine. The antibodies these individuals developed in response to the smallpox vaccine are removed and purified. This results in VIG. It can be administered intravenously. It is used to treat individuals who have developed progressive vaccinia after smallpox vaccination. It was also used along with cidofovir for the 2003 Midwest monkeypox outbreak as Concomitant drug, concomitant therapy to reduce the serious side effects of smallpox vaccine. In addition, CDC states that use of VIGIV may be considered for postexposure prophylaxis of monkeypox in exposed individuals who cannot receive postexposure vaccination with smallpox vaccine because of severe T-cell function immunodeficiency. Adverse effects of smallpox vaccine For a small percentage of the population, the smallpox vaccine either doesn't "take" or it produces adverse events. These include postvaccinial central ...
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WinRho
Rho(D) immune globulin (RhIG) is a medication used to prevent RhD isoimmunization in mothers who are RhD negative and to treat idiopathic thrombocytopenic purpura (ITP) in people who are Rh positive. It is often given both during and following pregnancy. It may also be used when RhD-negative people are given RhD-positive blood. It is given by injection into muscle or a vein. A single dose lasts 12 weeks. It is made from human blood plasma. Common side effects include fever, headache, pain at the site of injection, and red blood cell breakdown. Other side effects include allergic reactions, kidney problems, and a very small risk of viral infections. In those with ITP, the amount of red blood cell breakdown may be significant. Use is safe with breastfeeding. Rho(D) immune globulin is made up of antibodies to the antigen Rho(D) present on some red blood cells. It is believed to work by blocking a person's immune system from recognizing this antigen. Rho(D) immune globulin came ...
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Rho(D) Immune Globulin
Rho(D) immune globulin (RhIG) is a medication used to prevent RhD isoimmunization in mothers who are RhD negative and to treat idiopathic thrombocytopenic purpura (ITP) in people who are Rh positive. It is often given both during and following pregnancy. It may also be used when RhD-negative people are given RhD-positive blood. It is given by injection into muscle or a vein. A single dose lasts 12 weeks. It is made from human blood plasma. Common side effects include fever, headache, pain at the site of injection, and red blood cell breakdown. Other side effects include allergic reactions, kidney problems, and a very small risk of viral infections. In those with ITP, the amount of red blood cell breakdown may be significant. Use is safe with breastfeeding. Rho(D) immune globulin is made up of antibodies to the antigen Rho(D) present on some red blood cells. It is believed to work by blocking a person's immune system from recognizing this antigen. Rho(D) immune globulin ...
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Biomedical Advanced Research And Development Authority
The Biomedical Advanced Research and Development Authority (BARDA) is a U.S. Department of Health and Human Services (HHS) office responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological and nuclear (CBRN) threats, as well as pandemic influenza and emerging diseases. BARDA was established in 2006 through the Pandemic and All-Hazards Preparedness Act (PAHPA) and reports to the Office of the Assistant Secretary for Preparedness and Response (ASPR). The office manages Project BioShield, which funds the research, development and stockpiling of vaccines and treatments that the government could use during public health emergencies such as chemical, biological, radiological or nuclear (CBRN) attacks. In addition to preparing and maintaining bioterrorism responses and countermeasures, HHS, through the ASPR and BARDA, prepares and maintains an integrated system of medical countermeasu ...
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Anthrax Immune Globulin
Anthrax immune globulin, tradename Anthrasil, is a human immune globulin that is used in combination with antibiotics to treat anthrax. It was developed by Cangene and purchased in 2011 by the Biomedical Advanced Research and Development Authority (BARDA) under Project Bioshield. On 24 March 2015 it was granted approval by the United States Food and Drug Administration for use in treating inhalation anthrax in conjunction with antibiotics. __TOC__ Preparation Anthrax immune globulin is prepared from the plasma of donors who have been vaccinated against anthrax. Safety and efficacy testing Due to the ethical and feasibility concerns with testing the efficacy of anthrax immune globulin in humans, it was tested in rabbits and monkeys under the FDA's animal efficacy rule The Food and Drug Administration (United States), FDA animal efficacy rule (also known as animal rule) applies to Drug development, development and testing of drugs and biopharmaceutical, biologicals to reduce or pre ...
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Factor IX
Factor IX (or Christmas factor) () is one of the serine proteases of the coagulation system; it belongs to peptidase family S1. Deficiency of this protein causes haemophilia B. It was discovered in 1952 after a young boy named Stephen Christmas was found to be lacking this exact factor, leading to haemophilia. Coagulation factor IX is on the World Health Organization's List of Essential Medicines. Physiology Factor IX is produced as a zymogen, an inactive precursor. It is processed to remove the signal peptide, glycosylated and then cleaved by factor XIa (of the contact pathway) or factor VIIa (of the tissue factor pathway) to produce a two-chain form, where the chains are linked by a disulfide bridge. When activated into factor IXa, in the presence of Ca2+, membrane phospholipids, and a Factor VIII cofactor, it hydrolyses one arginine-isoleucine bond in factor X to form factor Xa. Factor IX is inhibited by antithrombin. Factor IX expression increases with age in humans ...
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Hepatitis B Immune Globulin
Hepatitis B immunoglobulin (HBIG) is a human immune globulin, immunoglobulin that is used to prevent the development of hepatitis B and is used for the treatment of acute exposure to HBsAg. Medical uses HBIG is indicated as a postexposure prophylaxis for people at risk to develop hepatitis B because they have been recently exposed to body fluids of individuals who have hepatitis B. This includes babies of mothers with hepatitis B, sexual partners, healthcare workers, police and fire workers, and morticians. It provides a temporarily induced Immunity (medical), immunity by the transfer of immunoglobulins. HBIG is given by either intramuscular (IM) or intravenous (IV) route, depending on the Pharmaceutical formulation, preparation. Side effects include allergic reactions, back pain, general feeling of discomfort, headaches, muscle pain, nausea, and pain or bleeding at the injection site. Allergy to human immunoglobulin is a contraindication. HIV has never been transmitted by HBIGDA- ...
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VZV Immune Globulin
VZV (varicella zoster virus) globulin or VZV antibodies is an immune system medication that is used mostly for immunosuppressed patients who have been or may be exposed to the varicella zoster virus. It shortens the course of cutaneous disease and may protect against its dissemination.Wilkinson, Iain and Lennox, Graham (June 2005). Essential Neurology (4th ed.). Wiley-Blackwell. p. 263 . Varicella zoster virus is a human herpes virus that causes chickenpox, shingles, Ramsay Hunt syndrome type II, and postherpetic neuralgia. Unlike a Zoster vaccine which provides durable immunity, the protection is passive and short term; it may need to be readministered every 2-4 weeks as necessary. This medication is not recommended for administration to immune-competent persons for the treatment of active disease. The immunoglobulin is prepared from the plasma of healthy donors with high titers of antibodies to VZV. A study was published in the Journal of Infectious Diseases that showed outdated ...
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