Data issue put Leo Pharma in the Danish Medicines Agency's crosshairs in 2021

During a good clinical practice inspection at Leo Pharma last year, the Danish Medicines Agency struggled to gain access to data related to two clinical eczema studies. The next step would have been ”regulatory action.”
Photo: Leo Pharma/PR
Photo: Leo Pharma/PR
by christian bundgaard, translated by daniel pedersen

Leo Pharma didn’t exactly welcome a good clinical practice (GCP) inspection by the Danish Medicines Agency with open arms last year and would have faced ”regulatory action” if it failed to hand over documents pertaining to clinical studies of eczema treatments tralokinumab and delgocitinib, industry media Dagens Pharma reports.

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