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Drug approvals and pharmaceutical affairs in Japan
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08/01/05
What is more difficult?
Filed under: Approvals
Posted by: Kanri @ 10:03 am

One of the unapproved anti-cancer products, recommended so far by the Committee for the Examination of the Use of Unapproved Medicinal Products for domestic development is thalidomide, which was once registered and in 1962 withdrawn in Japan. The task for clinical development with a sole indication for treatment of multiple myeloma is being undertaken by the Fujimoto Seiyaku KK. The Osaka-based company is small, discloses its staff (about 300), but not the revenues. Apparently, it is run in a very traditional way, so one may wonder how it will survive the PR barrage while developing the notorious compound. On July 20, 2005 in what it seemed as a rare press conference the Fujimoto’s management reported the progress in planning the clinical trials: IRBs of 22 hospitals accepted the protocol and the recruitment of patients through informed consent has started. However, the trials are amidst of a considerable controversy. While for years the Japanese branch of International Myeloma Foundation (IFM Japan) has lobbied for official registration (in contrary to private use legal import), the relatives of the 60s disaster victims are voicing strong concerns regarding the safety. Surprisingly or not, no references of any kind about thalidomide on the web site of Fujimoto have been posted.

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