Word: uclaf
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...have fought to introduce it to the U.S. as the first alternative to surgical abortion. The FDA under President Bush banned its import in 1989, citing safety concerns. On his third day in office, President Clinton lifted the ban and ordered the FDA to begin safety testing. Developer Roussel Uclaf, meanwhile, sick of getting hammered by both sides, donated U.S. patent rights for mifepristone to the Population Council, a nonprofit reproductive-rights group founded 50 years ago by John D. Rockefeller. The council had to steer the drug through U.S. trials, file the applications for approval, weather the political storms...
...Instead, Roussel-UCLAF, which holds the pill's 20-year-old patent, granted sole American distribution rights to the Population Council, a nonprofit organization specializing in reproductive issues, with the understanding the group would conduct clinical trials and find a manufacturer for the drug. And after six years of research and more than a few last-minute panic attacks from would-be manufacturing companies, the moment has arrived. The Population Council concluded a hugely successful drug trial in which 92 percent of the participants achieved successful medical abortions - the remaining 8 percent required surgical intervention to complete the procedure. Within...
...Instead, Roussel-UCLAF, the patent holder of the 20-year-old pill, granted sole American distribution rights to the Population Council, a nonprofit organization specializing in reproductive issues, with the understanding that the group would conduct clinical trials and find a manufacturer for the drug. After six years of research and more than a few last-minute panic attacks from would-be manufacturing companies, the moment of reckoning has arrived: The Population Council has concluded a hugely successful drug trial in which 92 percent of the participants achieved a "favorable" outcome and a marketing group, Banco Laboratories, and manufacturer...
PARIS: Bowing to boycott threats from American anti-abortion groups, European pharmaceutical giant Hoechst transferred non-U.S. patent rights to the abortion pill RU-486 to one of the doctors who invented it. Although Edouard Sakiz, who headed Roussel Uclaf, the company that lead the development of RU-486 before it was acquired by Hoechst, will market the drug worldwide through a new company, he said he will not do business in the U.S. Once the drug wins approval, it will be distributed by The Population Council, a New York-based non-profit that received the U.S. patent from...
Only a few years ago, it looked as if American women might never have access to RU-486, whose chemical name is mifepristone. It has been available in Europe since 1988, but the French manufacturer, Roussel Uclaf, fearing harassment by militant antiabortionists, refused to market it in the U.S. In 1994, though, the New York City-based Population Council offered to take the heat and acquired the drug's American patent rights. After two years of clinical trials, the organization applied to the FDA for permission to sell the drug. In July an advisory committee recommended approval...