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Neurocrine Biosciences
Neurocrine Biosciences, Inc. is an American biopharmaceutical company founded in 1992. The company is headquartered in San Diego, California, and led by CEO Kevin Gorman. Neurocrine develops treatments for neurological and endocrine-related diseases and disorders. In 2017, the company's drug valbenazine (Ingrezza) was approved in the US to treat adults with tardive dyskinesia (TD). The company is also developing treatments that are in various stages of clinical research for Parkinson's disease, Tourette syndrome, and congenital adrenal hyperplasia and with a partner for endometriosis and uterine fibroids. History Neurocrine was founded in San Diego, California, in 1992. The company's academic founders were Wylie Vale of the Salk Institute for Biological Studies, and Lawrence Steinman of Stanford University. The company was backed by Avalon Ventures among others. In 1995, the company collaborated with Belgium-based Janssen Pharmaceutica N.V. to develop treatments for psychiatric ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Lawrence Steinman
Lawrence Steinman is an immunologist and neurologist professor of pediatrics at Stanford University. Since 2015, he has been a member of the National Academy of Sciences The National Academy of Sciences (NAS) is a United States nonprofit, non-governmental organization. NAS is part of the National Academies of Sciences, Engineering, and Medicine, along with the National Academy of Engineering (NAE) and the Nati .... References American immunologists American pediatricians Stanford University staff Living people Year of birth missing (living people) Place of birth missing (living people) Date of birth missing (living people) {{med-bio-stub ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 (O ..., 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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Non-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 (O ..., 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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Indiplon
Indiplon (INN and USAN) is a nonbenzodiazepine, hypnotic sedative that was developed in two formulations—an immediate-release formulation for sleep onset, and a modified-release (also called controlled-release or extended-release) version for sleep maintenance. Mode of action Indiplon works by enhancing the action of the inhibitory neurotransmitter GABA, like most other nonbenzodiazepine sedatives. It primarily binds to the α1 subunits of the GABAA receptors in the brain. History Indiplon was discovered at Lederle Laboratories (which was later acquired by Wyeth) in the 1980s and was called CL 285,489. In 1998 Lederle licensed it, along with other early stage drug candidates, to DOV Pharmaceutical, a startup formed by former Lederle employees, and Dov exclusively sublicensed its rights in the drug to Neurocrine Biosciences in that same year. In 2002, Neurocrine entered into an agreement with Pfizer to develop the drug. Indiplon was originally scheduled for release in 200 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Insomnia
Insomnia, also known as sleeplessness, is a sleep disorder in which people have trouble sleeping. They may have difficulty falling asleep, or staying asleep as long as desired. Insomnia is typically followed by daytime sleepiness, low energy, irritability, and a depressed mood. It may result in an increased risk of motor vehicle collisions, as well as problems focusing and learning. Insomnia can be short term, lasting for days or weeks, or long term, lasting more than a month. The concept of the word insomnia has two possibilities: insomnia disorder and insomnia symptoms, and many abstracts of randomized controlled trials and systematic reviews often underreport on which of these two possibilities the word insomnia refers to. Insomnia can occur independently or as a result of another problem. Conditions that can result in insomnia include psychological stress, chronic pain, heart failure, hyperthyroidism, heartburn, restless leg syndrome, menopause, certain medications, and d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 had i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
GlaxoSmithKline
GSK plc, formerly GlaxoSmithKline plc, is a British multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham. GSK is the tenth largest pharmaceutical company and #294 on the 2022 ''Fortune'' Global 500, ranked behind other pharmaceutical companies China Resources, Sinopharm, Johnson & Johnson, Pfizer, Roche, AbbVie, Novartis, Bayer, and Merck. The company has a primary listing on the London Stock Exchange and is a constituent of the FTSE 100 Index. , it had a market capitalisation of £70 billion, the eighth largest on the London Stock Exchange. It has a secondary listing on the New York Stock Exchange. The company developed the first malaria vaccine, RTS,S, which it said in 2014 it would make available for five percent above cost. Legacy products developed at GSK include several listed in the World Health Organization's List of Essential Medicines, such ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Eli Lilly And Company
Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries. Its products are sold in approximately 125 countries. The company was founded in 1876 by, and named after, Colonel Eli Lilly, a pharmaceutical chemist and veteran of the American Civil War. As of 2022, Lilly is known for its clinical depression drugs Prozac ( fluoxetine) (1986) and Cymbalta (duloxetine) (2004) and its antipsychotic medication Zyprexa (olanzapine) (1996), although its primary revenue drivers are the diabetes drugs Humalog (insulin lispro) (1996) and Trulicity (dulaglutide) (2014). Lilly's achievements include being the first company to mass-produce the polio vaccine developed by Jonas Salk, and insulin. It was one of the first pharmaceutical companies to produce human insulin using recombinant DNA including Humulin ( insulin medication), Humalog (insulin lispro), and the first approved biosimilar insulin product in the US, Basaglar ( ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
NASDAQ
The Nasdaq Stock Market () (National Association of Securities Dealers Automated Quotations Stock Market) is an American stock exchange based in New York City. It is the most active stock trading venue in the US by volume, and ranked second on the list of stock exchanges by market capitalization of shares traded, behind the New York Stock Exchange. The exchange platform is owned by Nasdaq, Inc., which also owns the Nasdaq Nordic stock market network and several U.S.-based stock and options exchanges. History 1971–2000 "Nasdaq" was initially an acronym for the National Association of Securities Dealers Automated Quotations. It was founded in 1971 by the National Association of Securities Dealers (NASD), now known as the Financial Industry Regulatory Authority (FINRA). On February 8, 1971, the Nasdaq stock market began operations as the world's first electronic stock market. At first, it was merely a "quotation system" and did not provide a way to perform electronic trade ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Initial Public Offering
An initial public offering (IPO) or stock launch is a public offering in which shares of a company are sold to institutional investors and usually also to retail (individual) investors. An IPO is typically underwritten by one or more investment banks, who also arrange for the shares to be listed on one or more stock exchanges. Through this process, colloquially known as ''floating'', or ''going public'', a privately held company is transformed into a public company. Initial public offerings can be used to raise new equity capital for companies, to monetize the investments of private shareholders such as company founders or private equity investors, and to enable easy trading of existing holdings or future capital raising by becoming publicly traded. After the IPO, shares are traded freely in the open market at what is known as the free float. Stock exchanges stipulate a minimum free float both in absolute terms (the total value as determined by the share price multiplied by the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
