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Savient Pharmaceuticals
Savient Pharmaceuticals was a New Jersey-based biopharmaceutical company. Its lead product, pegloticase, was a biologic drug for treatment resistant chronic gout, which it marketed beginning in 2011. It also marketed oxandrolone beginning in 1995. History Savient was incorporated in 1980 as Bio-Technology General Corp and changed its name in 2003. Savient later focused on commercializing pegloticase in the United States and completing the development and seeking regulatory approval in the European Union. The company also sold branded and generic versions of oxandrolone, a drug used to promote weight gain following involuntary weight loss. John H. Johnson was CEO from February 2011 until February 2012, formerly employed by Imclone Systems ImClone Systems Incorporated was a biopharmaceutical company dedicated to developing biologic medicines in the area of oncology. It was founded in 1984 and had its corporate headquarters in Bridgewater, New Jersey, and its research headqua ...
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East Brunswick, New Jersey
East Brunswick is a township in Middlesex County, New Jersey, United States. The suburban bedroom community is part of the New York City metropolitan area and is located on the southern shore of the Raritan River, directly adjacent to the city of New Brunswick and located roughly away from New York City. According to the 2010 United States Census, the township's population was 47,512, reflecting an increase of 756 (+1.6%) from the 46,756 counted in the 2000 Census, which had in turn increased by 3,208 (+7.4%) from the 43,548 counted in the 1990 Census. East Brunswick was incorporated as a township by an act of the New Jersey Legislature on February 28, 1860, from portions of both Monroe Township and North Brunswick Township. Portions of the township were taken to form Washington town within the township (February 23, 1870; became independent as South River on February 28, 1898), Helmetta (March 20, 1888), Milltown (January 29, 1889) and Spotswood (April 15, 1908).Snyder ...
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Pegloticase
Pegloticase (trade name Krystexxa) is a medication for the treatment of severe, treatment-refractory, chronic gout. It is a third line treatment in those in whom other treatments are not tolerated. The drug is administered by infusion intravenously. It was developed by Savient Pharmaceuticals. It was approved in the United States in 2010, after two clinical trials found it lowered uric acid levels and reduced deposits of uric acid crystals in joints and soft tissue. The European Medicines Agency (EMA) granted marketing authorization in 2013 for treatment of disabling tophaceous gout. In 2016 this authorization was ended in Europe. Medical uses It is an option for the 3% of people with gout who are intolerant to other medications. Pegloticase is given as an intravenous infusion every two weeks, and has been found to reduce uric acid levels in this population. There is moderate quality evidence that It is useful for tophi but has a high rate of side effects and withdrawals due to ad ...
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Oxandrolone
Oxandrolone, sold under the brand names Oxandrin and Anavar, among others, is an androgen and anabolic steroid (AAS) medication which is used to help promote weight gain in various situations, to help offset protein catabolism caused by long-term corticosteroid therapy, to support recovery from severe burns, to treat bone pain associated with osteoporosis, to aid in the development of girls with Turner syndrome, and for other indications. It is taken by mouth. Side effects of oxandrolone include symptoms of masculinization such as acne, increased hair growth, voice changes, and increased sexual desire. The drug is a synthetic androgen and anabolic steroid, hence is an agonist of the androgen receptor (AR), the biological target of androgens such as testosterone and dihydrotestosterone. It has strong anabolic effects and weak androgenic effects, which give it a mild side effect profile and make it especially suitable for use in women. Oxandrolone was first described in 1962 an ...
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New Jersey
New Jersey is a state in the Mid-Atlantic and Northeastern regions of the United States. It is bordered on the north and east by the state of New York; on the east, southeast, and south by the Atlantic Ocean; on the west by the Delaware River and Pennsylvania; and on the southwest by Delaware Bay and the state of Delaware. At , New Jersey is the fifth-smallest state in land area; but with close to 9.3 million residents, it ranks 11th in population and first in population density. The state capital is Trenton, and the most populous city is Newark. With the exception of Warren County, all of the state's 21 counties lie within the combined statistical areas of New York City or Philadelphia. New Jersey was first inhabited by Native Americans for at least 2,800 years, with the Lenape being the dominant group when Europeans arrived in the early 17th century. Dutch and Swedish colonists founded the first European settlements in the state. The British later seized control o ...
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Biopharmaceutical
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms ''biological ...
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Pegloticase
Pegloticase (trade name Krystexxa) is a medication for the treatment of severe, treatment-refractory, chronic gout. It is a third line treatment in those in whom other treatments are not tolerated. The drug is administered by infusion intravenously. It was developed by Savient Pharmaceuticals. It was approved in the United States in 2010, after two clinical trials found it lowered uric acid levels and reduced deposits of uric acid crystals in joints and soft tissue. The European Medicines Agency (EMA) granted marketing authorization in 2013 for treatment of disabling tophaceous gout. In 2016 this authorization was ended in Europe. Medical uses It is an option for the 3% of people with gout who are intolerant to other medications. Pegloticase is given as an intravenous infusion every two weeks, and has been found to reduce uric acid levels in this population. There is moderate quality evidence that It is useful for tophi but has a high rate of side effects and withdrawals due to ad ...
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Biologic Medical Product
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms ''biological me ...
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Gout
Gout ( ) is a form of inflammatory arthritis characterized by recurrent attacks of a red, tender, hot and swollen joint, caused by deposition of monosodium urate monohydrate crystals. Pain typically comes on rapidly, reaching maximal intensity in less than 12 hours. The joint at the base of the big toe is affected in about half of cases. It may also result in tophi, kidney stones, or kidney damage. Gout is due to persistently elevated levels of uric acid in the blood. This occurs from a combination of diet, other health problems, and genetic factors. At high levels, uric acid crystallizes and the crystals deposit in joints, tendons, and surrounding tissues, resulting in an attack of gout. Gout occurs more commonly in those who: regularly drink beer or sugar-sweetened beverages; eat foods that are high in purines such as liver, shellfish, or anchovies; or are overweight. Diagnosis of gout may be confirmed by the presence of crystals in the joint fluid or in a deposit outsid ...
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European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been described as a '' sui generis'' political entity (without precedent or comparison) combining the characteristics of both a federation and a confederation. Containing 5.8per cent of the world population in 2020, the EU generated a nominal gross domestic product (GDP) of around trillion in 2021, constituting approximately 18per cent of global nominal GDP. Additionally, all EU states but Bulgaria have a very high Human Development Index according to the United Nations Development Programme. Its cornerstone, the Customs Union, paved the way to establishing an internal single market based on standardised legal framework and legislation that applies in all member states in those matters, and only those matters, where the states have agreed to act ...
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Imclone Systems
ImClone Systems Incorporated was a biopharmaceutical company dedicated to developing biologic medicines in the area of oncology. It was founded in 1984 and had its corporate headquarters in Bridgewater, New Jersey, and its research headquarters in New York City. On October 6, 2008, it accepted a $6.5 billion acquisition offer from Eli Lilly and Company, and became a fully-owned subsidiary of Eli Lilly and Company on November 24, 2008. Prior to the acquisition, it was traded on the NASDAQ stock exchange under the symbol IMCL. Imclone lost its separate identity in 2014 when its former ImClone research and manufacturing sites were renamed ''Eli Lilly and Company''. Insider trading scandal ImClone's stock price dropped sharply at the end of 2001 when its drug Erbitux, an experimental monoclonal antibody, failed to get the expected Food and Drug Administration (FDA) approval. It was later revealed by the U.S. Securities and Exchange Commission that numerous executives sold their sto ...
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Companies Formerly Listed On The Nasdaq
A company, abbreviated as co., is a legal entity representing an association of people, whether natural, legal or a mixture of both, with a specific objective. Company members share a common purpose and unite to achieve specific, declared goals. Companies take various forms, such as: * voluntary associations, which may include nonprofit organizations * business entities, whose aim is generating profit * financial entities and banks * programs or educational institutions A company can be created as a legal person so that the company itself has limited liability as members perform or fail to discharge their duty according to the publicly declared incorporation, or published policy. When a company closes, it may need to be liquidated to avoid further legal obligations. Companies may associate and collectively register themselves as new companies; the resulting entities are often known as corporate groups. Meanings and definitions A company can be defined as an "artificial per ...
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Biotechnology Companies Of The United States
Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used by Károly Ereky in 1919, meaning the production of products from raw materials with the aid of living organisms. Definition The concept of biotechnology encompasses a wide range of procedures for modifying living organisms according to human purposes, going back to domestication of animals, cultivation of the plants, and "improvements" to these through breeding programs that employ artificial selection and hybridization. Modern usage also includes genetic engineering as well as cell and tissue culture technologies. The American Chemical Society defines biotechnology as the application of biological organisms, systems, or processes by various industries to learning about the science of life and the improvement of the value of materials ...
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