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Approvals & Regulatory Updates, In Brief

Executive Summary

Peramivir gets stockpiled in case of influenza outbreak: BioCryst's I.V. antiviral peramivir is currently undergoing a pre-emergency use authorization review that could mean the I.V. product could be a future option in the event of a severe influenza outbreak, the firm announced May 8. CDC has confirmed sensitivity of the swine flu virus to peramivir; 10 of 13 isolates of the H1N1 virus were tested and all showed susceptibility to peramivir. Based on discussions with the HHS/Biomedical Advanced Research and Development Authority, BioCryst is preparing a portion of its inventory of finished peramivir for addition to the Strategic National Stockpile. The inventory could treat approximately one thousand patients. BioCryst also is in negotiations with the Division of Microbiology and Infectious Diseases and the National Institute of Allergy and Infectious Diseases to conduct a study of peramivir in a pediatric patient population. Clinical development of the product is advancing under a $102.6 million, four-year contract from HHS. Preliminary results of a Phase II study aimed at oseltamivir-resistance with an intramuscular formulation were not statistically significant, but a prior study by Shionogi showed efficacy for the I.V. formulation

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