BioCentury
ARTICLE | Clinical News

Sept. 13 Clinical Quick Takes: Amgen, Atara, MS biomarkers and switching in psoriasis

September 13, 2019 11:20 PM UTC

Clinical holds on two Amgen trials for cardiac safety signal
Amgen (NASDAQ:AMGN) said FDA placed a clinical hold on a Phase I trial of MCL1 inhibitor AMG 397 “to evaluate a safety signal for cardiac toxicity.” Amgen voluntarily halted enrollment in another Phase I trial of fellow MCL1 inhibitor AMG 176.

Post hoc analyses point to biomarkers to steer MS treatment decisions
Novartis AG (NYSE:NVS; SIX:NOVN) said new post hoc analyses from the Phase III FREEDOMS trial of Gilenya fingolimod in relapsing-remitting multiple sclerosis patients showed NEFL levels correlated with risk of disease worsening, and new data from the Phase III EXPAND trial showed GFAP concentrations were reduced from baseline with Mayzent siponimod compared with placebo in secondary progressive multiple sclerosis patients, suggesting blood levels of the proteins could be used as biomarkers to inform MS treatment management. Data were presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Stockholm...