Nippon Shoji On 105-Day Suspension
The Japanese Ministry of Health and Welfare has suspended drugmaker Nippon Shoji from pharmaceutical production for 105 days effective from December 18, according to local reports. The suspension is thought to be the longest ever for an infringement of the Drugs, Cosmetics and Medical Instruments Law.
The company's antiviral agent Usevir (sorivudine; Marketletters passim) was withdrawn within a month of its launch last September as a result of deaths linked to the drug's side effects. The Ministry is understood to have based its suspension on the company's failure to notify it of deaths of patients during clinical trials of the drug. The company is reported to have said that it did not report the deaths because it did not believe sorivudine to be the direct cause of death.
Nippon Shoji is currently under investigation for alleged insider trading (Marketletters June 27 and July 4), it is suspected that over 100 company employees and their relatives sold shares in the company ahead of the announcement of the sorivudine-related deaths.
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