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UCB Modeling Itself After Genentech As Next-Generation Biopharma Firm

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

UCB’s imminent submission of Cimzia for rheumatoid arthritis slated for the end of the year is another step toward a stronger biotech presence for the company.

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UCB To Provide More Cimzia Information Following FDA "Complete Response"

UCB will have to submit "additional information" and clarifications to FDA following receipt of a "complete response" letter from the agency for its PEGylated Fab fragment TNF inhibitor Cimzia (certolizumab pegol) for treatment of Crohn's disease, the company said Dec. 22

Abbott files Humira for Crohn’s

Abbott has submitted an sBLA for Humira (adalimumab) for treatment of moderate-to-severe Crohn's disease, the company announced Sept. 7. Abbott is highlighting its anti-tumor necrosis factor monoclonal antibody's dosing advantage over Johnson & Johnson's anti-TNF MAb Remicade (infliximab); Humira is injected subcutaneously every other week for Crohn's, while Remicade requires infusion. UCB's Cimzia (certolizumab pegol), a fragment of an anti-TNF MAb, is also dosed subcutaneously and is likely to be approved for Crohn's before Humira: UCB submitted a BLA Feb. 28, 2006, and is predicting launch in the first half of 2007...

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

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