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Japan’s MHLW Designates Three Drugs As Orphan Drugs

This article was originally published in PharmAsia News

Executive Summary

Japan's Ministry of Health, Labour and Welfare designated three drugs as orphan drugs, including two items for one drug for different indications. They are: Otsuka's tuberculoses drug OPC-67683 for preventing multi-drug resistance, currently in Phase II trials overseas; Celgene's CC-5013 (lenalidomide) for treating multiple myeloma in Phase I trials in Japan; and Celgene's CC-5013 for treating anemia caused by myelodysplastic syndrome. MHLW also reported that Chugai's Herceptin 60 and 150 injection is expected to be approved in March. (Click for more-Japanese language

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