Gilead Sciences, Inc. is calling off its effort to pursue accelerated approval of magrolimab in myelodysplastic syndrome (MDS), while the US Food and Drug Administration has placed partial clinical holds on additional Phase II trials of the drug, in multiple myeloma and diffuse large B-cell lymphoma (DLBCL), the company said in its fourth quarter earnings report.
Gilead also reached a settlement with GlaxoSmithKline plc and ViiV Healthcare regarding the HIV drug Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), whereby the company will pay GSK and ViiV $1