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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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Factor VIIa
Coagulation factor VII (, formerly known as proconvertin) is one of the proteins that causes blood to clot in the coagulation cascade, and in humans is coded for by the gene ''F7''. It is an enzyme of the serine protease class. Once bound to tissue factor released from damaged tissues, it is converted to factor VIIa (or ''blood-coagulation factor VIIa'', ''activated blood coagulation factor VII''), which in turn activates factor IX and factor X. Using genetic recombination a recombinant factor VIIa (eptacog alfa) (trade names include NovoSeven) has been approved by the FDA for the control of bleeding in hemophilia. It is sometimes used unlicensed in severe uncontrollable bleeding, although there have been safety concerns. A biosimilar form of recombinant activated factor VII (AryoSeven) is also available, but does not play any considerable role in the market. In April 2020, the US FDA approved a new rFVIIa product, eptacog beta (SEVENFACT), the first bypassing agent (BPA) approv ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Contract Manufacturing Organization
A contract manufacturing organization (CMO), more recently referred to (and more commonly used now) as a contract development and manufacturing organization (CDMO) to avoid the acronym confusion of Chief Medical Officer or Clinical Monitoring Organization in the pharma industry, is a company that serves other companies in the pharmaceutical industry on a contract basis to provide comprehensive services from drug development Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for re ... through drug manufacturing. This allows major pharmaceutical companies to outsourcing, outsource those aspects of the business, which can help with scalability or can allow the major company to focus on drug discovery and drug marketing instead. Services offered by CDMOs include, but are not limited to: pre-formul ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Hepatitis B Immune Globulin
Hepatitis B immunoglobulin (HBIG) is a human 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 by the transfer of immunoglobulins. HBIG is given by either intramuscular (IM) or intravenous (IV) route, depending on the 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 HBIG. [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Strategic National Stockpile
The Strategic National Stockpile (SNS), originally called the National Pharmaceutical Stockpile (NPS), is the United States' national repository of antibiotics, vaccines, chemical antidotes, antitoxins, and other critical medical supplies. Its website states: "The Strategic National Stockpile's role is to supplement state and local supplies during public health emergencies. Many states have products stockpiled, as well. The supplies, medicines, and devices for life-saving care contained in the stockpile can be used as a short-term stopgap buffer when the immediate supply of adequate amounts of these materials may not be immediately available." In at least 10 government reports published from 2003 to 2015, federal officials predicted that the U.S. would experience a shortage of ventilators and other medical supplies were a large-scale infectious disease outbreak to occur. Locations The actual supply of drugs and supplies that make up the SNS are located in 12 secret locations st ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Baltimore
Baltimore ( , locally: or ) is the most populous city in the U.S. state of Maryland, fourth most populous city in the Mid-Atlantic, and the 30th most populous city in the United States with a population of 585,708 in 2020. Baltimore was designated an independent city by the Constitution of Maryland in 1851, and today is the most populous independent city in the United States. As of 2021, the population of the Baltimore metropolitan area was estimated to be 2,838,327, making it the 20th largest metropolitan area in the country. Baltimore is located about north northeast of Washington, D.C., making it a principal city in the Washington–Baltimore combined statistical area (CSA), the third-largest CSA in the nation, with a 2021 estimated population of 9,946,526. Prior to European colonization, the Baltimore region was used as hunting grounds by the Susquehannock Native Americans, who were primarily settled further northwest than where the city was later built. Colonist ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Philadelphia
Philadelphia, often called Philly, is the largest city in the Commonwealth of Pennsylvania, the sixth-largest city in the U.S., the second-largest city in both the Northeast megalopolis and Mid-Atlantic regions after New York City. Since 1854, the city has been coextensive with Philadelphia County, the most populous county in Pennsylvania and the urban core of the Delaware Valley, the nation's seventh-largest and one of world's largest metropolitan regions, with 6.245 million residents . The city's population at the 2020 census was 1,603,797, and over 56 million people live within of Philadelphia. Philadelphia was founded in 1682 by William Penn, an English Quaker. The city served as capital of the Pennsylvania Colony during the British colonial era and went on to play a historic and vital role as the central meeting place for the nation's founding fathers whose plans and actions in Philadelphia ultimately inspired the American Revolution and the nation's inde ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
