“The Pink Sheet” DAILY – Most Notable Stories Of 2012
This article was originally published in The Pink Sheet Daily
A baker’s dozen stories from the past year that captured reader interest and reflected biopharma trends.
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Some early meeting requests from potential biosimilar sponsors were not held because they did not include the necessary information for FDA to give development advice.
The agency’s report on innovative drug approvals in FY 2012 documents the successful performance metrics for the 35 novel medicines, including first-cycle review rates and on-time user fee targets, but it notes that a larger problem lies in early stages of drug discovery and development – and it thinks it can help.
Pfizer’s newly approved oral RA therapy Xeljanz has an oral advantage over established immune modulators, which all are delivered by needle, but safety questions may slow its adoption.