Inpharma 1646 - 12 Jul 2008
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■ Additional data is required by European regulatory authorities considering IDM Pharma’s marketing authorisation application for mifamurtide [L-MTP-PE] in the treatment of osteosarcoma. The CHMP said it would like to see further data from the phase III L-MTP-PE trial and posed several questions regarding the recent inspection of the Children’s Oncology Group; there are also chemistry, manufacturing and control issues to be answered. The CHMP is likely to review IDM Pharma’s responses at its September meeting. IDM Pharma Inc. IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following June Meeting of European Committee for Medicinal Products for Human Use (CHMP). Media Release : 1 Jul 2008. 809090690 Available from: URL: http://www.idm-pharma.com
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Inpharma 12 Jul 2008 No. 1646