The UK regulator uncovered some discrepancies with Good Clinical Practice in its investigation into the Phase I safety trial of TeGenero AG's TGN1412, but stuck to the original conclusion that the life-threatening cytokine storm suffered by six health volunteers was due to "an unexpected biological effect." "We are satisfied the adverse incidents that occurred were not as a result of any errors made in the manufacture of TGN1412, its formulation, dilution or administration to trial participants," said Kent Woods, chief executive of the Medicines and Healthcare Products Regulatory Agency (MHRA). The final report on what caused the fiasco at Northwick Park Hospital in London on March 13 …
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