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Among them is a death in connection with anti-cancer drugs. The Japanese branch of Novartis must refine its approach, if a rule violation in the disclosure xv of adverse reaction cases were known, xv Novartis said on Monday.
This had ordered the Japanese agency for pharmaceutical and food security on July 31. It is about the results of studies on three methods of treatment. Affected subjects from studies on cancer xv drugs
Subject of studies were given for the treatment of leukemia drug Glivec and Tasigna and the breast xv cancer drug Afinitor. Novartis announced last Friday to have the health authorities reported the results of his investigations.
The affected employees, namely those of the marketing department, the importance of the problems xv were not fully aware of and would therefore not forwarded the information to the responsible entity, Novartis said. The laboratory has also made a mistake in monitoring by the supervisor submits. Not the first problem in Japan
Recently, the Japanese subsidiary xv of Novartis has been rocked by a series of scandals. The first broke out last year when two Japanese universities denounced the manipulation of the results of clinical trials.
Due to this affair and several other problems Novartis cleaned up in its Japanese branch with the iron broom in April. xv The Group exchanged from the top management of the subsidiary. Investors unimpressed
The difficulties in Japan, however, have caused no uneasiness among investors. This turned their attention rather on the results of a phase III trial, which were presented late last week on the occasion of a cardiologist Congress in Barcelona.
The study found that one-fifth fewer patients died during treatment with the drug LCZ696 with chronic heart failure from circulatory problems than taking an older drug. The drug could reach the market next year. The Novartis title on Monday reached a new all-time high. (Sda)
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