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Merck's Keytruda hits the skids in pivotal trial, putting its liver cancer nod at risk fiercepharma
February 24, 2019
Merck & Co.’s immunotherapy Keytruda has been hitting its trial targets so often, it’s tempting to think it can't miss. But it can—and Tuesday’s data in liver cancer proves it.
NeuroRx plans pivotal trial after seeing hints of efficacy in suicidal patients fiercebiotech
December 26, 2018
NeuroRx is planning to move NRX-101 into phase 2b/3 after detecting signs of efficacy in a feasibility trial in patients with suicidal bipolar depression.
Esperion's LDL drug aces a third pivotal trial fiercebiotech
May 29, 2018
In its third pivotal trial readout this year, the 180-mg dose of Esperion's LDL cholesterol-lowering treatment, bempedoic acid, hit its primary endpoint in a trial of high-risk patients with atherosclerotic cardiovascular disease (ASCVD).
1000 patient Phase III study required for Armetheon before FDA approval europeanpharmaceuticalreview
February 13, 2017
Armetheon has reached agreement with the US Food and Drug Administration (FDA) for a single 1000 patient final pivotal trial for its drug candidate, tecarfarin, prior to filing an NDA, which is currently projected to occur in 2019.