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ViroPharma Could Manufacture Cinryze "At Risk" Starting Next Year

This article was originally published in The Pink Sheet Daily

Executive Summary

Delay in application for industrial scale production illustrates the challenges that biosimilar manufacturers will face.

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Biosimilars: FDA's Meeting Notice Upgrades Safety To "Paramount"

Updated outline of November meeting discussion points includes several tweaks to the pharmacovigilance section.

Dyax Kalbitor Is Third To Market For HAE, But First For All Acute Attacks

Overcoming an FDA advisory committee that expressed doubts about efficacy and potential hypersensitivity reactions and a "complete response" letter asking for a Risk Evaluation and Mitigation Strategy, Dyax won approval for Kalbitor (ecallantide) Nov. 27 to treat acute attacks of hereditary angioedema in patients 16 and older

FDA Won’t Require A Verification Study For Genzyme’s Lumizyme

Genzyme expects to resubmit its BLA, which received a complete response, by mid-May and have a six-month review.

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