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Roche Checks Wallet As Important Avastin Trial Flops

Executive Summary

After months of anticipation, Roche announced the results of a closely watched clinical trial showing that its Avastin (bevacizumab) medication failed to prevent the recurrence of early-stage colon cancer in patients who underwent surgery

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And The Winner Is… Biotech Products Will Steal Top Drug Sales Spots In 2014

The six best-selling drugs will all be biotech products, with Roche’s Avastin and Abbott’s Humira in the lead, new report says.

Approvals & Regulatory Updates, In Brief

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

Approvals & Regulatory Updates, In Brief

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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