Novartis A pharmaceuticals news

Novartis said that an ongoing, internal review of adverse event reporting practices in the pharma’s Japanese Novartis Pharma K.K. (NPKK) business unit has revealed about 10,000 previously unreported individual case safety reports. The pharma said it has not determined if any of the cases were associated with confirmed or serious adverse events. NPKK reported the findings to Japan’s Ministry of Health, Labor and Welfare (MHLW) and all global health authorities earlier this month. The pharma said NPKK associates will be required to undergo additional adverse event reporting training. Novartis said the most frequently cited medicines in the case safety reports are cancer drugs Glivec imatinib, Tasigna nilotinib and Afinitor/ Certican everolimus; hematology drug Exjade deferasirox; acromegaly and neuroendocrine tumor drug Sandostatin octreotide acetate; autoimmune drug Neoral cyclosporine; neurology drug Exelon rivastigmine; osteoporosis drug Zometa zoledronic acid; and inflammatory drug Xolair omalizumab.

Novartis began the third-party review of investigator-initiated trials in February. In April, Novartis appointed new senior executives in Japan after a preliminary review of a report by an independent panel uncovered possible breaches of patient confidentiality and instances of document destruction in the investigator-initiated, Japanese Phase IV SIGN trial of Tasigna in chronic myelogenous leukemia (CML) patients. Novartis has placed a temporary hold on all investigator-initiated funding in Japan (see BioCentury, April 14). ...