Worries about unpredictable, potentially life-threatening effects of an orphan drug for treating a non-fatal condition. Missing data and uncertainty over the efficacy of the product even though it met its primary endpoint in a Phase III trial. A decision in the EU that contrasts sharply with the viewpoint in the US.
The statements all relate to Turalio (pexidartinib), Daiichi Sankyo’s drug for tenosynovial giant cell tumor (TGCT), and the European Medicines...
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