Novartis Needs A Bigger Safety Database For Menveo, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Review of application for ages 11 and up proceeds, but the agency wants to see more data on infants, pushing a second filing for the meningitis vaccine to 2011 in the U.S.
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Although only a few months are at stake, this is the second setback this year for the product, which Novartis hopes will validate its vaccine investments.
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Novartis has suffered yet another setback over Menveo, its meningococcal meningitis vaccine, thanks to an FDA request for additional information about unspecified clinical and manufacturing issues