Gilead Announces Partial Clinical Hold for Studies Evaluating Magrolimab in Combination With Azacitidine
Gilead Sciences, Inc. (GILD)
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Source: Business Wire
-- Enrolled Patients in These Studies May Continue Receiving Study Medicine ---- Studies Outside of Combination with Azacitidine Unaffected -- FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between study arms. While no clear trend in the adverse reactions or new safety signal has been identified by Gilead at this time, the partial clinical hold is being implemented by Gilead across all ongoing magrolimab and azacitidine combination studies worldwide in the best interests of patients as additional data is gathered and analyzed to address the concerns raised by FDA.During the partial clinical hold, screening and enrollment of new study participants will be paused in any study investi
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