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Cangene lands hemophilia asset slapped with FDA complete response letter

This article was originally published in Scrip

Executive Summary

Cangene must be feeling hard done by this week. Ipsen of France and its US partner Inspiration Biopharmaceuticals, which filed for Chapter 11 bankruptcy protection last October, revealed that they received a complete response letter (CRL) for the hemophilia B product, IB1001 (recombinant factor IX). They broke the news simultaneously with the closing of the sale of the asset to Cangene. The deal was first announced on 6 February but it is unclear exactly when the CRL was received. No mention was made of the CRL prior to today.



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