Alzheimer's Biomarkers Gain Prominence In Drug Development Guidance
US FDA revises draft guidance issued in 2013 to allow research targeting cognition as single endpoint and studies solely evaluating biomarkers; document offers 'potential for multiple advances,' Alzheimer's Association says.
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Eisai/Biogen Remain In BACE Race As Alzheimer's Contenders Dwindle
Multiple competitors have ended development of BACE inhibitors for the treatment of Alzheimer's disease, but Eisai neurology executive Lynn Kramer tells Scrip that the company still sees a path forward for certain amyloid-targeting drugs.
Pharmas Join To Build Inflammation Biomarkers In Alzheimer's, Depression
Drug firms exploring link between inflammation and central nervous system disorders are now sharing resources through public/private Biomarkers Consortium project.
Biogen Spooks With Phase III Aducanumab Changes
Recruiting more patients into a trial to retain statistical power is standard practice, but with other companies discontinuing late-stage investigational Alzheimer's therapies, the difficulty in maintaining confidence in the development of new therapies for the condition has been underlined by investor responses to Biogen's alterations.