MedWatch

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

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.

The media has seen the agency’s inspection report from March 2021, which said the agency couldn’t gain access to information about certain computer systems that were used to handle study data, which is one of the essential elements of the clinical process, Dagens Pharma writes.

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