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Clene's ALS drug shows reduction in disease indicator levels in trial

Clene said on Thursday its experimental amyotrophic lateral sclerosis (ALS) drug showed reduction in levels of an indicator believed to be tied with the disease progression in a mid-stage trial. ....

Krishna Chandra Eluri , Raghav Mahobe , Lou Gehrig , Thomson Reuters Trust Principles , Drug Administration , Krishna Chandra , Thomson Reuters Trust , Rsbi Regulatory Oversight , Rhpi Biopharma , Rhpi Regulatory ,

US FDA panel backs approval for Eisai-Biogen Alzheimer's drug Leqembi

Expected FDA approval would make Leqembi the first in its class of drugs that work by removing sticky amyloid plaques from the brain to achieve the regulatory milestone. ....

United States , Tanya Simuni , Joanne Pike , Khushi Mandowara , Robert Alexander , Leroy Leo , Julie Steenhuysen , Banner Alzheimer Institute , Drug Administration , Northwestern University Feinberg School Of Medicine , Thomson Reuters Trust Principles , Alzheimer Association , Advisory Committee , Northwestern University Feinberg School , Banner Alzheimer , Thomson Reuters Trust , Rsbi Regulatory Oversight , Rhpi Approvals , Rhpi Biopharma , Rhpi Drug Device Trials , Rhpi Regulatory , Ef Business Future Of Health ,

Medicare to broaden coverage for new Alzheimer's drugs after full approval

The U.S. Medicare health plan said on Thursday it would limit reimbursement for Eisai Co Ltd and Biogen Inc's Alzheimer's drug Leqembi to patients whose doctors participate in a health agency database should the drug win full approval, a move advocates say will hinder its use. ....

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Japan's Otsuka Pharma gets FDA approval for Alzheimer's agitation drug

The U.S. Food and Drug Administration approved Otsuka Pharmaceutical's brexpiprazole to treat agitation in patients with Alzheimer's on Thursday, making it the first approved drug for the indication, the company said in a statement. ....

Aditya Samal , Shounak Dasgupta , Thomson Reuters Trust Principles , Drug Administration , Lundbeck Hlunb , Otsuka Pharmaceutical , Thomson Reuters Trust , Rsbi Regulatory Oversight , Rhpi Approvals , Rhpi Drug Device Trials , Rhpi Regulatory , Ef Business Future Of Health ,

Eisai, Biogen Alzheimer's drug Leqembi would cost US Medicare up to $5 bln a year, study finds

Wide coverage of Alzheimer's drug Leqembi would raise future costs for the U.S. Medicare health plan by $2 billion to $5 billion a year, according to a study led by researchers at the University of California, Los Angeles (UCLA). ....

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