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42 relations: Accelerated approval (FDA), Alpha-galactosidase, Biodollars, Biopharmaceutical, Biotech Week, CDKL5, Chairman, Chief financial officer, Chief operating officer, Chief scientific officer, Corporate title, Cranbury, New Jersey, Drugs.com, EDGAR, Enzyme replacement therapy, Epidermolysis bullosa, Fabry disease, Forbes, GlaxoSmithKline, Glycogen storage disease type II, HighBeam Research, Initial public offering, John Crowley (biotech executive), Lysosomal storage disease, MarketWatch, Migalastat, NASDAQ, New Drug Application, New Enterprise Associates, Pharmacological chaperone, Priority review, Radius Ventures, Rare disease, Recombinant DNA, Royal Society of Chemistry, San Diego, Scioderm, Scott Gottlieb, Seeking Alpha, Shire (pharmaceutical company), U.S. Securities and Exchange Commission, Venture capital financing.
Accelerated approval (FDA)
The United States Food and Drug Administration (FDA) initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need.
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Alpha-galactosidase
Alpha-galactosidase is a glycoside hydrolase enzyme that hydrolyses the terminal alpha-galactosyl moieties from glycolipids and glycoproteins.
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Biodollars
Biodollars, sometimes called biobucks, is a term commonly used in business transactions between large pharmaceutical and smaller biotechnology companies to describe the total possible value of the transaction, excluding royalty payments.
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Biopharmaceutical
A biopharmaceutical, also known as a biologic(al) medical product, biological, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources.
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Biotech Week
Biotech Week is a weekly biotechnology and pharmaceutical trade magazine.
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CDKL5
CDKL5 is a gene that provides instructions for making a protein called cyclin-dependent kinase-like 5 also known as serine/threonine kinase 9 (STK9) that is essential for normal brain development with mutations causing deficiencies in the protein level.
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Chairman
The chairman (also chairperson, chairwoman or chair) is the highest officer of an organized group such as a board, a committee, or a deliberative assembly.
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Chief financial officer
The chief financial officer (CFO) is the officer of a company that has primary responsibility for managing the company's finances, including financial planning, management of financial risks, record-keeping, and financial reporting.
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Chief operating officer
The chief operating officer (COO), also called the chief operations officer, is one of the highest-ranking executive positions in an organization, comprising part of the "C-Suite".
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Chief scientific officer
A chief science officer (C.S.O.) is a position at the head of scientific research operations at organizations or companies performing significant scientific research projects.
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Corporate title
Corporate titles or business titles are given to company and organization officials to show what duties and responsibilities they have in the organization.
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Cranbury, New Jersey
Cranbury is a township in Middlesex County, New Jersey, United States.
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Drugs.com
Drugs.com is an online pharmaceutical encyclopedia which provides drug information for consumers and healthcare professionals, primarily in the USA.
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EDGAR
EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system, performs automated collection, validation, indexing, acceptance, and forwarding of submissions by companies and others who are required by law to file forms with the U.S. Securities and Exchange Commission (the "SEC").
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Enzyme replacement therapy
Enzyme replacement therapy (ERT) is a medical treatment which replaces an enzyme that is deficient or absent in the body.
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Epidermolysis bullosa
Epidermolysis bullosa (EB) is a group of genetic conditions that result in easy blistering of the skin and mucous membranes.
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Fabry disease
Fabry disease is a rare genetic disease.
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Forbes
Forbes is an American business magazine.
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GlaxoSmithKline
GlaxoSmithKline plc (GSK) is a British pharmaceutical company headquartered in Brentford, London.
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Glycogen storage disease type II
Glycogen storage disease type II, also called Pompe disease, is an autosomal recessive metabolic disorder which damages muscle and nerve cells throughout the body.
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HighBeam Research
HighBeam Research is a paid search engine and full text online archive owned by Gale, a subsidiary Cengage, for thousands of newspapers, magazines, academic journals, newswires, trade magazines, and encyclopedias in English.
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Initial public offering
Initial public offering (IPO) or stock market launch is a type of public offering in which shares of a company are sold to institutional investors and usually also retail (individual) investors; an IPO is underwritten by one or more investment banks, who also arrange for the shares to be listed on one or more stock exchanges.
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John Crowley (biotech executive)
John Francis Crowley (born April 7, 1967) is an American biotechnology executive and entrepreneur and the chairman and CEO of Amicus Therapeutics.
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Lysosomal storage disease
Lysosomal storage diseases (LSDs) are a group of about 50 rare inherited metabolic disorders that result from defects in lysosomal function.
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MarketWatch
MarketWatch operates a financial information website that provides business news, analysis, and stock market data.
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Migalastat
Migalastat (or 1-deoxygalactonojirimycin; trade names Galafold and formerly Amigal) is a drug for the treatment of Fabry disease, a rare genetic disorder. It was developed by Amicus Therapeutics. The US Food and Drug Administration (FDA) assigned it orphan drug status in 2004, and the European Committee for Medicinal Products for Human Use (CHMP) followed in 2006. The European Commission approved the drug in May 2016.
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NASDAQ
The Nasdaq Stock Market is an American stock exchange.
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New Drug Application
The Food and Drug Administration's New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
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New Enterprise Associates
New Enterprise Associates (NEA) is an American-based venture capital firm.
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Pharmacological chaperone
A pharmacological chaperone (or pharmacoperone, from "protein chaperone") is a small molecule that enters cells and serves as a molecular scaffolding in order to cause otherwise-misfolded mutant proteins to fold and route correctly within the cell.
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Priority review
Priority review is a mechanism used by the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease.
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Radius Ventures
Radius Ventures is a venture capital firm located in New York that invests in expansion-stage health and life sciences companies.
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Rare disease
A rare disease is any disease that affects a small percentage of the population.
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Recombinant DNA
Recombinant DNA (rDNA) molecules are DNA molecules formed by laboratory methods of genetic recombination (such as molecular cloning) to bring together genetic material from multiple sources, creating sequences that would not otherwise be found in the genome.
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Royal Society of Chemistry
The Royal Society of Chemistry (RSC) is a learned society (professional association) in the United Kingdom with the goal of "advancing the chemical sciences".
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San Diego
San Diego (Spanish for 'Saint Didacus') is a major city in California, United States.
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Scioderm
Scioderm, acquired by Amicus Therapeutics in 2015, was a rare disease company focused on developing a treatment for Epidermolysis Bullosa (EB), a rare genetic disease characterized by extremely fragile skin and recurrent blister formation.
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Scott Gottlieb
Scott Gottlieb (born June 11, 1972) is an American physician who serves as commissioner of the Food and Drug Administration.
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Seeking Alpha
Seeking Alpha is a crowd-sourced content service for financial markets.
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Shire (pharmaceutical company)
Shire Plc is a Jersey-registered, Irish-headquartered global specialty biopharmaceutical company.
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U.S. Securities and Exchange Commission
The U.S. Securities and Exchange Commission (SEC) is an independent agency of the United States federal government.
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Venture capital financing
Venture capital financing is a type of financing by venture capital.
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References
[1] https://en.wikipedia.org/wiki/Amicus_Therapeutics
