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Wednesday, June 25, 2014

FDA panel votes for more data before approval of AstraZeneca drug, (NYSE: AZN)

An advisory panel to the U.S. Food and Drug Administration recommended on Wednesday that AstraZeneca Plc be required to submit further clinical data before its experimental ovarian cancer drug is approved.The panel voted 11-2 that the company should complete a second trial to confirm results seen in a smaller study which, while positive, were not robust enough to convince the committee that they could be reproduced.Panel members expressed concern about a potential increased risk of secondary cancers in patients receiving the drug, olaparib, as well as side effects such as nausea and gastrointestinal disturbances.The FDA is not obliged to follow the advice of its advisory panels but typically does so.

AstraZeneca PLC (AstraZeneca) is a global biopharmaceutical company. Shares of AZN traded higher by 0.72% or $0.53/share to $74.17. In the past year, the shares have traded as low as $47.16 and as high as $82.68. On average, 5262120 shares of AZN exchange hands on a given day and today's volume is recorded at 1293823.