China Medical divests ultrasound biz: China Medical Technologies divests its high-intensity focused ultrasound (HIFU) tumor therapy business to shareholder Chengxuan International for $53.5 million in order to refocus on in vitro diagnostics. Xiaodong Wu, who is both CEO of CMT and owner of Chengxuan, did not take part in deliberations over the sale, which was approved by CMT's independent board members, CMT notes. Announced Dec. 31, the move reflects pressures on the HIFU business from the global financial crisis, stricter regulations on medical equipment by China's State FDA, and the financial burden involved in obtaining U.S. and EU regulatory approvals for HIFU equipment, CMT explains. Beijing-based CMT recently acquired a human papillomavirus genotyping assay for $345 million, which it expects will generate up to $26.5 million in sales this year; the company will use the proceeds from the HIFU sale to further develop its molecular diagnostics business (1"The Gray Sheet" Oct. 13, 2008, p. 8)

China Medical Technologies is acquiring a human papillomavirus genotyping assay which it expects will generate up to $26.5 million in sales next year

US WorldMeds NDA package for eflornithine for high-risk neuroblastoma provides “a higher level of uncertainty than is typically seen in oncology applications,” agency says. Though FDA seems largely satisfied with the sponsor’s externally controlled study, confirmatory evidence may be lacking.