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Top related persons:
Denis Balibouse - 1 Eli Lilly - 1 Dr - 1 Sarah Kremen - 1 Eliezer Masliah - 1 Eisai - 1 Michael Irizarry - 1 Roche - 1
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Geneva Switzerland Leqembi Eisai Los Angeles U.S
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Memory Centre - 1 of Readaptation - 1 University Hospital - 1 REUTERS - 1 FDA - 1 Sinai Medical Center - 1 Wednesday - 1 Quest Diagnostics - 1

Search resuls for: "Russ Paulsen"


2 mentions found


☆ Blood tests needed for widespread Alzheimer's diagnosis on the way
  + stars: | 2023-10-11 | by ( Deena Beasley | ) www.reuters.com   time to read: +6 min
Several Alzheimer's blood tests are in the works – and one is already being sold to consumers – but none have been established as accurate, formally approved by regulators or reimbursed by insurers. Researchers have been working for years on blood tests for Alzheimer's that can replicate these diagnostic tools. The need for blood tests has become more pressing since the FDA approved Leqembi in July. Accurate blood tests are expected to help identify which dementia patients actually have Alzheimer’s, the most common but not the only cause of dementia. "When there are widely available, scalable, sensitive and specific blood tests it will be an absolute game changer for Alzheimer's patients."
Persons: Denis Balibouse, Eli Lilly, Dr, Sarah Kremen, Eliezer Masliah, Eisai, Michael Irizarry, Roche, Bruce Jordan, Russ Paulsen, Deena Beasley, Caroline Humer, Bill Berkrot Organizations: Memory Centre, of Readaptation, University Hospital, REUTERS, FDA, Sinai Medical Center, Wednesday, Quest Diagnostics, National Institute, Aging, U.S . National Institutes of Health, C2N Diagnostics, Roche Diagnostics, Alzheimer's Association, RAND, Thomson Locations: Geneva, Switzerland, Leqembi, Eisai, Los Angeles, U.S
☆ Eli Lilly says U.S. FDA rejects accelerated approval for Alzheimer's drug
  + stars: | 2023-01-19 | by ( Deena Beasley | ) www.reuters.com   time to read: +3 min
REUTERS/Mike SegarJan 19 (Reuters) - Eli Lilly and Co on Thursday said the U.S. Food and Drug Administration had rejected accelerated approval of its experimental Alzheimer's drug because it had not submitted enough trial data from patients who were treated for at least a year. That study, Lilly said, would form the basis of donanemab's application for traditional FDA approval shortly thereafter. The FDA can grant "accelerated" approval to drugs based on their impact on a measurement, in this case amyloid brain plaques, likely to correlate with patient response. Donanemab is in the same class as aducanumab and lecanemab, the latter being a treatment for early Alzheimer's that was given accelerated approval by the FDA earlier this month. Sales of amyloid-lowering Alzheimer's drugs, which need to be given by infusion, are expected to be minimal until they receive standard FDA approval.
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