GSK’s Anthrax Treatment Raxibacumab Gets Second Chance To Be First Animal Rule NME
This article was originally published in The Pink Sheet Daily
FDA’s Anti-Infective Drugs Advisory Committee will have new pharmacokinetic data to review when it meets Nov. 2 to discuss the monoclonal antibody, which targets the anthrax toxin rather than the pathogen.
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An additional animal study that Human Genome Sciences did after receiving a “complete response” letter from FDA showed clinical benefit for raxibacumab, but with a p-value higher than the standard maximum value of 0.05.
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