Regulators order AB Science to halt trial work on PhIII ALS drug, demanding proof it's cleaned up
Just weeks after laying out claims on positive Phase III data for their ALS drug masitinib, French regulatory authorities are dropping the hammer on AB Science, ordering a halt to clinical research work on the drug until the biotech can prove it’s compliant with rules governing drug study conduct.
In a release out early Friday, the biotech said that the Agence Nationale de la Sécurité des Médicaments is demanding an external audit to clear their work on trial procedures. AB Science says that the ANSM zeroed in on a troubled study —AB06006 — involving masitinib in treating mastocytosis. But those problems, the biotech kicked back, all occurred between 2009 and 2015, before they put a new quality control system in place.
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