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Amylin Pharmaceuticals
Amylin Pharmaceuticals, Inc. is a biopharmaceutical founded in 1987 that was based in San Diego, California. The company was engaged in the discovery, development, and commercialization of drug candidates for the treatment of diabetes, obesity, and other diseases. Amylin produced three drugs: Symlin ( pramlintide acetate), Byetta ( exenatide) and Bydureon (exenatide extended release). History 1987–1992: Founding and IPO In 1987, Amylin Pharmaceuticals was co-founded by Howard E. Greene Jr., former CEO of San Diego biotech pioneer Hybridtech, to develop a treatment for diabetes from a synthetic analog of amylin. Amylin was discovered by researchers at Oxford University earlier that year. Greene was CEO from 1987 to 1996. Amylin completed its IPO in 1992. 1992–1998: Invention of Pramlintide and partnership with Johnson & Johnson Amylin, in its natural form, is sticky, clumping on needles and forming little rocks in the pancreas. To create a synthetic version that was ...
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Subsidiary
A subsidiary, subsidiary company, or daughter company is a company (law), company completely or partially owned or controlled by another company, called the parent company or holding company, which has legal and financial control over the subsidiary company. Unlike regional branches or divisions, subsidiaries are considered to be distinct entities from their parent companies; they are required to follow the laws of where they are incorporated, and they maintain their own executive leadership. Two or more subsidiaries primarily controlled by same entity/group are considered to be sister companies of each other. Subsidiaries are a common feature of modern business, and most multinational corporations organize their operations via the creation and purchase of subsidiary companies. Examples of holding companies are Berkshire Hathaway, Jefferies Financial Group, The Walt Disney Company, Warner Bros. Discovery, and Citigroup, which have subsidiaries involved in many different Industry (e ...
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Los Angeles Times
The ''Los Angeles Times'' is an American Newspaper#Daily, daily newspaper that began publishing in Los Angeles, California, in 1881. Based in the Greater Los Angeles city of El Segundo, California, El Segundo since 2018, it is the List of newspapers in the United States, sixth-largest newspaper in the U.S. and the largest in the Western United States with a print circulation of 118,760. It has 500,000 online subscribers, the fifth-largest among U.S. newspapers. Owned by Patrick Soon-Shiong and published by California Times, the paper has won over 40 Pulitzer Prizes since its founding. In the 19th century, the paper developed a reputation for civic boosterism and opposition to Trade union, labor unions, the latter of which led to the Los Angeles Times bombing, bombing of its headquarters in 1910. The paper's profile grew substantially in the 1960s under publisher Otis Chandler, who adopted a more national focus. As with other regional newspapers in California and the United Sta ...
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Glucagon
Glucagon is a peptide hormone, produced by alpha cells of the pancreas. It raises the concentration of glucose and fatty acids in the bloodstream and is considered to be the main catabolic hormone of the body. It is also used as a Glucagon (medication), medication to treat a number of health conditions. Its effect is opposite to that of insulin, which lowers extracellular glucose. It is produced from proglucagon, encoded by the ''GCG'' gene. The pancreas releases glucagon when the amount of glucose in the bloodstream is too low. Glucagon causes the liver to engage in glycogenolysis: converting stored glycogen into glucose, which is released into the bloodstream. High blood-glucose levels, on the other hand, stimulate the release of insulin. Insulin allows glucose to be taken up and used by insulin-dependent tissues. Thus, glucagon and insulin are part of a feedback system that keeps blood glucose levels stable. Glucagon increases energy expenditure and is elevated under conditions ...
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Insulin
Insulin (, from Latin ''insula'', 'island') is a peptide hormone produced by beta cells of the pancreatic islets encoded in humans by the insulin (''INS)'' gene. It is the main Anabolism, anabolic hormone of the body. It regulates the metabolism of carbohydrates, fats, and protein by promoting the absorption of glucose from the blood into cells of the liver, fat cell, fat, and skeletal muscles. In these tissues the absorbed glucose is converted into either glycogen, via glycogenesis, or Fatty acid metabolism#Glycolytic end products are used in the conversion of carbohydrates into fatty acids, fats (triglycerides), via lipogenesis; in the liver, glucose is converted into both. Glucose production and secretion by the liver are strongly inhibited by high concentrations of insulin in the blood. Circulating insulin also affects the synthesis of proteins in a wide variety of tissues. It is thus an anabolic hormone, promoting the conversion of small molecules in the blood into large ...
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GLP-1
Glucagon-like peptide-1 (GLP-1) is a 30- or 31-amino-acid-long peptide hormone deriving from tissue-specific posttranslational processing of the proglucagon peptide. It is produced and secreted by intestinal enteroendocrine L-cells and certain neurons within the nucleus of the solitary tract in the brainstem upon food consumption. The initial product GLP-1 (1–37) is susceptible to amidation and proteolytic cleavage, which gives rise to the two truncated and equipotent biologically active forms, GLP-1 (7–36) amide and GLP-1 (7–37). Active GLP-1 protein secondary structure includes two α-helices from amino acid position 13–20 and 24–35 separated by a linker region. Alongside glucose-dependent insulinotropic peptide (GIP), GLP-1 is an incretin; thus, it has the ability to decrease blood sugar levels in a glucose-dependent manner by enhancing the secretion of insulin. Beside the insulinotropic effects, GLP-1 has been associated with numerous regulatory and protective ef ...
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Gila Monster
The Gila monster (''Heloderma suspectum'', ) is a species of venomous lizard native to the Southwestern United States and the northwestern Mexico, Mexican state of Sonora. It is a heavy, slow-moving reptile, up to long, and it is the only venomous lizard native to the United States. Its venomous close relatives, the four Mexican beaded lizard, beaded lizards (all former subspecies of ''Heloderma horridum'') inhabit Mexico and Guatemala. The Gila monster is sluggish in nature, so it is not generally dangerous and very rarely poses a real threat to humans. However, it has a fearsome reputation and is sometimes killed despite the species being protected by state law in Arizona. History The name "Gila" refers to the Gila River Basin in the U.S. states of Arizona and New Mexico, where the Gila monster was once plentiful. ''Heloderma'' means "studded skin", from the Ancient Greek words (), "the head of a nail or stud", and (), "skin". The species epithet ''suspectum'' comes fr ...
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Approvable Letter
Approvable letters, and the related non-approvable letters (alternately not-approvable letters), were notifications sent out by the Food and Drug Administration (FDA) to drug manufacturers alerting them to the approval prospects of their drugs under development. The letters were intended to let manufacturers know how much work is needed on their applications. Non-approval letters were rejections of a drug's application. Approvable and non-approvable letters were covered under Title 21 of the Code of Federal Regulations Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy ..., section 314.110. In 2018, the FDA replaced approvable letters with Complete Response Letters (CRL) to notify applicants when additional information is required before approval. Guidelines Approvable letters were iss ...
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Regulatory Pipeline
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For example: * in government, typically regulation (or its plural) refers to the delegated legislation which is adopted to enforce primary legislation; including land-use regulation * in economy: regulatory economics * in finance: financial regulation * in business, industry self-regulation occurs through self-regulatory organizations and trade associations which allow industries to set and enforce rules with less government involvement; and, * in biology, gene regulation and metabolic regulation allow living organisms to adapt to their environment and maintain homeostasis; * in psychology, self-regulation theory is the study of how individuals regulate their thoughts and behaviors to reach goals. Forms Regulation in the social, political ...
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Diabetes Mellitus Type 2
Type 2 diabetes (T2D), formerly known as adult-onset diabetes, is a form of diabetes mellitus that is characterized by high blood sugar, insulin resistance, and relative lack of insulin. Common symptoms include increased thirst, frequent urination, fatigue and unexplained weight loss. Other symptoms include increased hunger, having a sensation of pins and needles, and sores (wounds) that heal slowly. Symptoms often develop slowly. Long-term complications from high blood sugar include heart disease, stroke, diabetic retinopathy, which can result in blindness, kidney failure, and poor blood flow in the lower limbs, which may lead to amputations. A sudden onset of hyperosmolar hyperglycemic state may occur; however, ketoacidosis is uncommon. Type 2 diabetes primarily occurs as a result of obesity and lack of exercise. Some people are genetically more at risk than others. Type 2 diabetes makes up about 90% of cases of diabetes, with the other 10% due primaril ...
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Hypoglycemia
Hypoglycemia (American English), also spelled hypoglycaemia or hypoglycæmia (British English), sometimes called low blood sugar, is a fall in blood sugar to levels below normal, typically below 70 mg/dL (3.9 mmol/L). Whipple's triad is used to properly identify hypoglycemic episodes. It is defined as blood glucose below 70 mg/dL (3.9 mmol/L), symptoms associated with hypoglycemia, and resolution of symptoms when blood sugar returns to normal. Hypoglycemia may result in headache, tiredness, clumsiness, trouble talking, confusion, fast heart rate, sweating, shakiness, nervousness, hunger, loss of consciousness, seizures, or death. Symptoms typically come on quickly. Symptoms can remain even soon after raised blood level. The most common cause of hypoglycemia is diabetes medication, medications used to treat diabetes such as insulin (medication), insulin, sulfonylureas, and biguanides. Risk is greater in diabetics who have eaten less than usual, recently exe ...
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Diabetes Mellitus Type 1
Type 1 diabetes (T1D), formerly known as juvenile diabetes, is an autoimmune disease that occurs when the body's immune system destroys pancreatic cells (beta cells). In healthy persons, beta cells produce insulin. Insulin is a hormone required by the body to store and convert blood sugar into energy. T1D results in hyperglycemia, high blood sugar levels in the body prior to treatment. Common symptoms include polyuria, frequent urination, polydipsia, increased thirst, polyphagia, increased hunger, weight loss, and other complications. Additional symptoms may include blurry vision, fatigue (medical), tiredness, and slow wound healing (owing to impaired blood flow). While some cases take longer, symptoms usually appear within weeks or a few months. The cause of type 1 diabetes is not completely understood, but it is believed to involve a combination of genetic and environmental factors. The underlying mechanism involves an autoimmune destruction of the insulin-producing beta cells ...
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Glycemic Control
Diabetes mellitus is a metabolic disease that is characterized by chronic elevated blood glucose levels (hyperglycemia). Therefore, the main goal of diabetes management is to keep blood glucose levels within normal limits or a target range as much as possible. If diabetes is not well controlled, further challenges to health may occur. People with diabetes can measure blood sugar by various methods, such as with a glucose meter or a continuous glucose monitor, which monitors over several days. Glucose can also be measured by analysis of a routine blood sample. In addition to lifestyle modification, some individuals may need medications to adequately control their blood sugar levels. Other goals of diabetes management are prevention or treatment of complications that can result from the disease itself and from its treatment. Description Diabetes is a well known chronic disease that affects many individuals of all ages worldwide. There are many subtypes including Type 1, Type 2, ...
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