French Ask Bial For More Preclinical Data On FAAH Inhibitor
This article was originally published in SRA
The expert committee set up by the French medicines regulator ANSM to look into the preclinical data on Bial's FAAH inhibitor, BIA 10-2474, following the death of a volunteer and the hospitalization of several others during a Phase I study, has asked the Portuguese company for more data to support the committee's preliminary conclusion that the results of animal studies justified moving the compound into human trials1.
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.