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Dalbavancin
Dalbavancin, sold under the brand names Dalvance in the US and Xydalba in the EU among others, is a second-generation lipoglycopeptide antibiotic medication. It belongs to the same class as vancomycin, the most widely used and one of the treatments available to people infected with methicillin-resistant ''Staphylococcus aureus'' (MRSA). Dalbavancin is a semisynthetic lipoglycopeptide that was designed to improve upon the natural glycopeptides vancomycin and teicoplanin. It is derived from a complex of glycopeptide antibiotics, referred to as A-40926, that is produced by a new strain of Actinomadura. Dalbavancin has been referred to in the scientific literature by a series of names: MDL-63397, A-!-1, BI-397, VER-001. These different labels reflected where the research had been carried out: MDL representing Merrell-Dow-Lepetit, where the initial complex was discovered; BI referring to BioSearch Italia where Dalbavancin itself was first synthesized; VER referring to Versicor (wh ...
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Dalbavancin Core
Dalbavancin, sold under the brand names Dalvance in the US and Xydalba in the EU among others, is a second-generation glycopeptide antibiotic, lipoglycopeptide antibiotic medication. It belongs to the same class as vancomycin, the most widely used and one of the treatments available to people infected with methicillin-resistant Staphylococcus aureus, methicillin-resistant ''Staphylococcus aureus'' (MRSA). Dalbavancin is a semisynthetic lipoglycopeptide that was designed to improve upon the natural glycopeptides vancomycin and teicoplanin. It is derived from a complex of glycopeptide antibiotics, referred to as A-40926, that is produced by a new strain of Actinomadura. Dalbavancin has been referred to in the scientific literature by a series of names: MDL-63397, A-!-1, BI-397, VER-001. These different labels reflected where the research had been carried out: MDL representing Merrell-Dow-Lepetit, where the initial complex was discovered; BI referring to BioSearch Italia where Dalbav ...
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Durata Therapeutics
Durata Therapeutics was a clinical development stage company in the pharmaceutical industry which focused on the treatment of infections. On November 17, 2014, the company was acquired by Actavis (now Allergan) for $675 million. History On December 21, 2009, the company acquired Vicuron Pharmaceuticals and its drug candidate, dalbavancin, a long-acting semisynthetic lipoglycopeptide antibiotic, from Pfizer and commenced operations. On April 19, 2011, the company initiated Phase III studies of dalbavancin for intravenous (IV) treatment of acute bacterial skin and skin structure infections. In 2012, the company moved its global headquarters from Morristown to Chicago (''City in a Garden''); I Will , image_map = , map_caption = Interactive Map of Chicago , coordinates = , coordinates_footnotes = , subdivision_type = Country , subdivision_name ... and received $2 million in tax credits. References {{DEFAULTSOR ...
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Actavis
Actavis Generics (formerly known as Watson Pharmaceuticals and Actavis plc, prior to the acquisition of Irish-based Allergan Inc) is a global pharmaceutical company focused on acquiring, developing, manufacturing and marketing branded pharmaceuticals, generic and over-the-counter medicines, and biologic products. Actavis has a commercial presence across approximately 100 countries. The company has global headquarters in Dublin, Ireland and administrative headquarters in Parsippany-Troy Hills, New Jersey, United States. Actavis PLC markets brand products through six franchises in key therapeutic categories including: Aesthetics/Dermatology/Plastic Surgery; Neurosciences/CNS; Eye Care; Women's Health and Urology; GI and Cystic Fibrosis; and Cardiovascular Disease and Infectious Disease. The company's products include Botox, Namenda, Restasis, Linzess, Bystolic, Juvederm, Latisse, Lo Loestrin Fe, Estrace, Teflaro, Dalvance, Ozurdex, Optive, Natrelle, Viibryd, Liletta, S ...
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Intravenous Therapy
Intravenous therapy (abbreviated as IV therapy) is a medical technique that administers fluids, medications and nutrients directly into a person's vein. The intravenous route of administration is commonly used for rehydration or to provide nutrients for those who cannot, or will not—due to reduced mental states or otherwise—consume food or water by mouth. It may also be used to administer medications or other medical therapy such as blood products or electrolytes to correct electrolyte imbalances. Attempts at providing intravenous therapy have been recorded as early as the 1400s, but the practice did not become widespread until the 1900s after the development of techniques for safe, effective use. The intravenous route is the fastest way to deliver medications and fluid replacement throughout the body as they are introduced directly into the circulatory system and thus quickly distributed. For this reason, the intravenous route of administration is also used for the cons ...
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ABSSSI
Skin and skin structure infections (SSSIs), also referred to as skin and soft tissue infections (SSTIs), or acute bacterial skin and skin structure infections (ABSSSIs), are infections of skin and associated soft tissues (such as loose connective tissue and mucous membranes). Historically, the pathogen involved has most frequently been a bacterial species—always, since redescription of SSSIs as ABSSSIs—and as such, these infections require treatment by antibiotics. Types Until 2008, a distinction was made between two types: complicated SSSIs (cSSSIs) and uncomplicated SSSIs (uSSSIs), which had different regulatory approval requirements. Uncomplicated SSSIs included "simple abscesses, impetiginous lesions, furuncles, and cellulitis." Complicated SSSIs included "infections either involving deeper soft tissue or requiring significant surgical intervention, such as infected ulcers, burns, and major abscesses or a significant underlying disease state that complicates the response to ...
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Pfizer
Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer (1824–1906) and his cousin Charles F. Erhart (1821–1891). Pfizer develops and produces medicines and vaccines for immunology, oncology, cardiology, endocrinology, and neurology. The company has several blockbuster drugs or products that each generate more than billion in annual revenues. In 2020, 52% of the company's revenues came from the United States, 6% came from each of China and Japan, and 36% came from other countries. Pfizer was a component of the Dow Jones Industrial Average stock market index from 2004 to August 2020. The company ranks 64th on the Fortune 500 and 49th on the Forbes Global 2000. History 1849–1950: Early history Pfizer was founded in 1849 by Charles Pfizer and Charles F. Erhart, two cousins who ha ...
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Metabolism
Metabolism (, from el, μεταβολή ''metabolē'', "change") is the set of life-sustaining chemical reactions in organisms. The three main functions of metabolism are: the conversion of the energy in food to energy available to run cellular processes; the conversion of food to building blocks for proteins, lipids, nucleic acids, and some carbohydrates; and the elimination of metabolic wastes. These enzyme-catalyzed reactions allow organisms to grow and reproduce, maintain their structures, and respond to their environments. The word metabolism can also refer to the sum of all chemical reactions that occur in living organisms, including digestion and the transportation of substances into and between different cells, in which case the above described set of reactions within the cells is called intermediary (or intermediate) metabolism. Metabolic reactions may be categorized as '' catabolic'' – the ''breaking down'' of compounds (for example, of glucose to pyruvate ...
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Red Man Syndrome (Drug Eruption)
Vancomycin is a glycopeptide antibiotic medication used to treat a number of bacterial infections. It is recommended intravenously as a treatment for complicated skin infections, bloodstream infections, endocarditis, bone and joint infections, and meningitis caused by methicillin-resistant ''Staphylococcus aureus''. Blood levels may be measured to determine the correct dose. Vancomycin is also taken by mouth as a treatment for severe ''Clostridium difficile'' colitis. When taken by mouth it is poorly absorbed. Common side effects include pain in the area of injection and allergic reactions. Occasionally, hearing loss, low blood pressure, or bone marrow suppression occur. Safety in pregnancy is not clear, but no evidence of harm has been found, and it is likely safe for use when breastfeeding. It is a type of glycopeptide antibiotic and works by blocking the construction of a cell wall. Vancomycin was approved for medical use in the United States in 1958. It is on the Worl ...
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Qualified Infectious Disease Product
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against. Title I: Fees Relating to Drugs Title I extends through FY2017 the authority of the FDA, through the authority of the Secretary of Health and Human Services, to collect drug application and supplement fees, prescription drug establishment fees, and prescription drug product fees to support the FDA process for reviewing human drug applications. It requires the FDA to submit annually to the House ...
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Skin And Skin Structure Infection
Skin and skin structure infections (SSSIs), also referred to as skin and soft tissue infections (SSTIs), or acute bacterial skin and skin structure infections (ABSSSIs), are infections of skin and associated soft tissues (such as loose connective tissue and mucous membranes). Historically, the pathogen involved has most frequently been a bacterial species—always, since redescription of SSSIs as ABSSSIs—and as such, these infections require treatment by antibiotics. Types Until 2008, a distinction was made between two types: complicated SSSIs (cSSSIs) and uncomplicated SSSIs (uSSSIs), which had different regulatory approval requirements. Uncomplicated SSSIs included "simple abscesses, impetiginous lesions, furuncles, and cellulitis." Complicated SSSIs included "infections either involving deeper soft tissue or requiring significant surgical intervention, such as infected ulcers, burns, and major abscesses or a significant underlying disease state that complicates the response to ...
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Streptococcus Pyogenes
''Streptococcus pyogenes'' is a species of Gram-positive, aerotolerant bacteria in the genus '' Streptococcus''. These bacteria are extracellular, and made up of non-motile and non-sporing cocci (round cells) that tend to link in chains. They are clinically important for humans, as they are an infrequent, but usually pathogenic, part of the skin microbiota that can cause Group A streptococcal infection. ''S. pyogenes'' is the predominant species harboring the Lancefield group A antigen, and is often called group A ''Streptococcus'' (GAS). However, both ''Streptococcus dysgalactiae'' and the ''Streptococcus anginosus'' group can possess group A antigen as well. Group A streptococci, when grown on blood agar, typically produce small (2–3 mm) zones of beta-hemolysis, a complete destruction of red blood cells. The name group A (beta-hemolytic) ''Streptococcus'' (GABHS) is thus also used. The species name is derived from Greek words meaning 'a chain' () of berries ( at ...
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