Monday 25 June 2012

Food And Drug Administration-Blood Clot Preventer-Bristol-Myers Squibb-Health Regulators

Bristol/Pfizer clot preventer delayed in U.S

(Reuters) - A closely watched blood clot preventer from Bristol-Myers Squibb Co and Pfizer Inc has failed to win approval from U.S. health regulators, the companies said on Monday. Investors have been awaiting a decision on the drug, Eliquis, by the Food And Drug Administration by the end of the month. The FDA notification did not require the companies to complete any new studies, the companies said, which could mean only a short delay before the drug wins approval. Rather, the agency wants more information on data management and verification from a key clinical trial supporting the medicine. ... read more..

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