BioCentury
ARTICLE | Company News

May 2 Company Quick Takes: Agios, Celgene/Presage, Purdue, Amgen/Syapse

May 2, 2019 9:28 PM UTC

Label expansion in AML for Agios’ Tibsovo
FDA approved an sNDA for Tibsovo ivosidenib from Agios Pharmaceuticals Inc. (NASDAQ:AGIO) as monotherapy for adults with newly diagnosed acute myelogenous leukemia (AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation who are ineligible for intensive chemotherapy. The agency first approved Tibsovo in July 2018 for relapsed or refractory AML with a susceptible IDH1 mutation.

Celgene, Presage partner on microdosing trials
Celgene Corp. (NASDAQ:CELG) will tap Presage Biosciences (Seattle, Wash.) to evaluate its early stage cancer candidates in Phase 0 tumor microdosing clinical trials. Presage will use its CIVO intratumoral microdosing platform to evaluate patient responses to microdoses of Celgene's early pipeline agents and combinations for "actionable insights from the tumor microenvironment." Terms were not disclosed...