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13 relations: Asoprisnil ecamate, Clinical trial, Endometrium, International nonproprietary name, Mifepristone, Organic compound, Schering AG, Selective progesterone receptor modulator, Steroid, TAP Pharmaceuticals, Ulipristal acetate, Uterine fibroid, Vilaprisan.
Asoprisnil ecamate
Asoprisnil ecamate (INN) (developmental code name J-956) is a synthetic, steroidal selective progesterone receptor modulator (SPRM) which was under development for the treatment of endometriosis, uterine fibroids, and menopausal symptoms but was discontinued.
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Clinical trial
Clinical trials are experiments or observations done in clinical research.
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Endometrium
The endometrium is the inner epithelial layer, along with its mucous membrane, of the mammalian uterus.
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International nonproprietary name
The International Nonproprietary Name (INN) is an official generic and non-proprietary name given to a pharmaceutical drug or an active ingredient.
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Mifepristone
Mifepristone, also known as RU-486, is a medication typically used in combination with misoprostol, to bring about an abortion.
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Organic compound
In chemistry, an organic compound is generally any chemical compound that contains carbon.
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Schering AG
Schering AG was a research-centered German multinational pharmaceutical company headquartered in Wedding, Berlin, which operated as an independent company from 1851 to 2006.
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Selective progesterone receptor modulator
A selective progesterone receptor modulator (SPRM) is an agent that acts on the progesterone receptor.
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Steroid
A steroid is a biologically active organic compound with four rings arranged in a specific molecular configuration.
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TAP Pharmaceuticals
TAP Pharmaceuticals was formed in 1977 as a joint venture between the two global pharmaceutical companies, Abbott Laboratories and Takeda Pharmaceutical Co. and was dissolved in 2008; its two most successful products were proton-pump inhibitor lansoprazole (Prevacid) and the prostate cancer drug, leuprorelin ((Lupron). The intention of the joint venture was to get products that Takeda had discovered developed, approved, and marketed in the US and Canada. The company was established at a time when Japanese pharmaceutical companies were seeking partnerships to access the US market. These efforts were supported by the Japanese government at the time to help the national economy compete in higher technology, as countries like South Korea, Taiwan were beginning to catch up with Japan in commodity production. Japanese pharmaceutical companies were especially strong in the fields of generating analogs of known cephalosporin antibiotics, cancer drugs, and cardiovascular drugs. The first products TAP file new drug applications for, were two cephalosporins, cefmenoxime (Cefmax) and cefsulodin (Cefonomil), estazolam for sleep disorders, and leuprorelin; leuprorelin was the first one approved, in 1985. In 1998 Takeda established its own US R&D and sales force, for the diabetes drug pioglitazone (Actos). In 2000, TAP's withdrew its new drug application for apomorphine (branded as "Uprima") as a treatment for erectile dysfunction after an FDA review panel raised questions about the drug's safety, due to many clinical trial subjects fainting after taking the drug. In 2001, the US Department of Justice, states attorneys general, and TAP Pharmaceutical Products settled criminal and civil charges against TAP related to federal and state medicare fraud and illegal marketing of the drug leuprorelin. TAP paid a total of $875 million, which was a record high at the time. The $875 million settlement broke down to $290 million for violating the Prescription Drug Marketing Act, $559.5 million to settle federal fraud charges for overcharging Medicare, and $25.5 million reimbursement to 50 states and Washington, D.C., for filing false claims with the states' Medicaid programs. The case arose under the False Claims Act with claims filed by Douglas Durand, a former TAP vice president of sales, and Joseph Gerstein, a doctor at Tufts University's HMO practice. Durand, Gerstein, and Tufts shared $95 million of the settlement. When the settlement was announced, the Department of Justice also announced that seven people were indicted on criminal charges by a grand jury; the DoJ also said that four doctors had already pled guilty for receiving kickbacks. As of 2003 around 12 TAP employees had been indicted and were contested the charges, and one had pled guilty. Abbott and Takeda agreed to end the partnership in 2008, with Abbott keeping the rights to leuprorelin, which had sales in 2007 of $600 million and a patent expiring in 2015 and the approximately 300 employees who worked on the product, and Takeda keeping the rights to lansoprazole, which had sales of $2.3 billion in 2007 but was facing imminent generic competition, along with 800 employees in the U.S. and all the drugs in the TAP pipeline. Takeda was also obligated to pay Abbott about $1.5 billion over several years. By 2008, Takeda's own sales in the US outside of TAP had grown to $3 billion, mostly from sales of pioglitazone which by then was the best-selling diabetes drug in the world.
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Ulipristal acetate
Ulipristal acetate, sold under the brand name Ella among others, is a medication used for emergency birth control and uterine fibroids.
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Uterine fibroid
Uterine fibroids, also known as uterine leiomyomas or fibroids, are benign smooth muscle tumors of the uterus.
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Vilaprisan
Vilaprisan (INN, USAN) (developmental code name BAY-1002670) is a synthetic, steroidal selective progesterone receptor modulator (SPRM) which is under development by Bayer HealthCare Pharmaceuticals for the treatment of endometriosis and uterine fibroids.
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