Novartis Pharma K.K. failed to inform the government of at least 10 suspected cases of serious side effects involving its Tasigna leukemia drug, it was learned Friday.
The Health, Labor and Welfare Ministry has opened an investigation into whether the Novartis unit broke the pharmaceutical affairs law, sources said.
But Novartis left the Tasigna cases unreported — until recently, the sources said. Sales representatives were aware of the side effect data produced by the questionnaire but did not report it to the corporate department in charge of the matter, according to the sources.
Two similar cases also came to light in connection with a scandal over the drugmaker’s inappropriate involvement in clinical trials. But these were later found not to be covered by the legal obligation, according to the ministry. (Ver)
The Japanese sales arm of the Swiss-based pharmaceutical giant Novartis is suspected of engaging in exaggerated advertising, using research papers based on falsified data on the effects of a popular drug to lower blood pressure. Based on a criminal accusation filed by the Health, Labor and Welfare Ministry, the Tokyo District Public Prosecutor’s Office has been interrogating people at Novartis Pharma and at five university hospitals involved in clinical research on the drug. (Ver)
JAPON: Novartis allanada. Por qué...?