Results 161 to 170 of about 5,494 (193)
Aducanumab for Alzheimer’s Disease: A Regulatory Perspective
Pharmacological Research, 2021 On June 7th 2021, the Food and Drug Administration (FDA) granted approval for Aduhelm (aducanumab) for the treatment of Alzheimer's disease under its accelerated approval program. Aducanumab is the first putative disease-modifying therapy (DMT) approved for the treatment of AD with a great potential for clinical benefit over current symptomatic ...
John Joseph Borg, Robert Nistico
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Aducanumab Anti-Amyloid Immunotherapy Induces Sustained Microglial and Immune Alterations [PDF]
Journal of Experimental MedicineAducanumab, an anti-amyloid immunotherapy for Alzheimer\u27s disease, efficiently reduces Aβ, though its plaque clearance mechanisms, long-term effects, and effects of discontinuation are not fully understood.
David M. Holtzman, Kimberly C Olney
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A Resurrection of Aducanumab for Alzheimer's Disease [PDF]
Lancet Neurology, The, 2020 Lon S Schneider
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Revisiting FDA Approval of Aducanumab
New England Journal of Medicine, 2021Revisiting FDA Approval of Aducanumab Given the scientific, regulatory, and clinical implications of the accelerated FDA approval of aducanumab for Alzheimer’s disease, it’s essential to consider b...
Richard J Kryscio, David S Knopman
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The Antibody Aducanumab Reduces Aβ Plaques in Alzheimer’s Disease
Nature, 2016 Alzheimer's disease (AD) is characterized by deposition of amyloid-β (Aβ) plaques and neurofibrillary tangles in the brain, accompanied by synaptic dysfunction and neurodegeneration.
Paul H. Weinreb +2 more
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Aducanumab, amyloid, and culture wars
BMJ, 2021Those who thought that the US Food and Drug Administration (FDA) was a conservative regulator which maintained a high bar have been shocked by its approval of the anti-amyloid antibody aducanumab. There is precedent. Former president Donald Trump championed hydroxychloroquine as a preventative against covid-19.
Iliffe, Steve, Manthorpe, Jill
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Aducanumab and the FDA — where are we now?
Nature Reviews Neurology, 2021The amyloid antibody aducanumab is currently undergoing review by the FDA. The treatment would be the first disease-modifying drug to be approved for Alzheimer disease; however, a medical advisory committee recently convened by the FDA did not recommend approval, raising questions about whether the existing evidence of efficacy is sufficient.
Howard Fillit, Allan Green
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Aducanumab for Alzheimer’s disease: Observations and opportunities
Australasian Psychiatry, 2022Objective To analyse the overseas approval of aducanumab for Alzheimer’s disease, in order to derive lessons of potential interest to individuals and groups involved in dementia drug development and regulation in Australia. Conclusions
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