FDA panel backs much-debated ALS drug in rare, second review
The ruling Wednesday was a remarkable turnaround for the much-debated medication that was previously rejected by the same group earlier this year.
Alzheimer's disease
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Lilly says it will push ahead on Alzheimer’s drug
The push by Eli Lilly and Co. will come despite an unfavorable ruling last week from Medicare that sharply restricts reimbursements for a drug in the same class.
Eli Lilly’s Alzheimer’s drug hits roadblock
The FDA has agreed to speed up review of donanemab, but the Centers for Medicare and Medicaid Services is moving to limit reimbursement for drugs in this class to only patients in clinical trials.
Medicare limits coverage of $28,000-a-year Alzheimer’s drug
Medicare officials stressed Tuesday that they did not take cost into account in the coverage decision, but rather whether Aduhelm is “reasonable and necessary” for treating Alzheimer’s patients enrolled in the program.
Medicare told to reassess premium hike caused by Alzheimer’s drug
U.S. health secretary Xavier Becerra on Monday ordered Medicare to reassess a big premium increase facing millions of seniors this year, attributed in large part to a pricey new Alzheimer’s drug with questionable benefits.
After uproar over FDA’s handling of Biogen Alzheimer’s drug, Lilly presses on
Even as some drugmakers, including Indianapolis-based Eli Lilly and Co., are pushing to get experimental drugs approved, federal regulators are still dealing with a huge blowback over the controversial way they reviewed a new Alzheimer’s drug by rival Biogen.
FDA narrows use of Alzheimer’s drug to patients with early-stage disease
The narrower label means the drug might be offered to 1 million or 2 million Alzheimer’s patients, rather than the more than 6 million people with Alzheimer’s in the United States.
Controversial OK of Alzheimer’s drug reignites battle over disease’s cause
The role of the sticky substance in the brain has long divided researchers and is at the forefront again amid the FDA’s recent clearance of the first drug to treat the disease in almost two decades.
UPDATE: Lilly to seek FDA approval for potential Alzheimer’s drug
Eli Lilly and Co. shares jumped more than 9% Thursday morning after it received “breakthrough therapy” designation for donanemab from the U.S. Food and Drug Administration, putting the drug on a path that could expedite its development.
Furor rages over FDA approval of controversial Alzheimer’s drug
Critics have blasted the approval of Aduhelm, saying the drug—with a list price of $56,000 a year per patient—offers false hope while threatening Medicare’s financial health and patients’ pocketbooks.
Medicare copays for new Alzheimer’s drug could reach $11,500
Separately, Dr. Aaron Kesselheim of Harvard University became the third member of an FDA advisory panel that opposed the drug to step down over the decision to approve it.
Lilly’s stock gets big boost from competitor’s new Alzheimer’s treatment
Shares of Biogen competitors soared after aducanumab became the first drug cleared by the U.S. Food and Drug Administration to slow the course of the mind-wasting disease that afflicts 6 million Americans.
FDA approves much-debated Alzheimer’s drug panned by experts
The decision, which could affect millions of older Americans and their families, also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.
Lilly’s Alzheimer’s drug shows modest benefit in mid-stage trial
Eli Lilly and Co. on Saturday morning presented highly anticipated details from a mid-stage study showing that its experimental drug slowed Alzheimer’s disease progression over about 18 months.
Lilly stock poised for record if Alzheimer’s drug results shine
Indianapolis-based Eli Lilly and Co. is set to report results from a trial of its experimental Alzheimer’s medicine on Saturday in a move that could boost shares of the year’s already best-performing big drugmaker.
Deaths from Alzheimer’s disease, other dementias jumped in 2020, report says
Preliminary reports from the Centers for Disease Control and Prevention indicate that there were at least 42,000 more deaths from Alzheimer’s and other dementias in 2020 compared with the average of the five years prior.
Hope at Lilly after years of Alzheimer’s failures
Lilly has spent three decades and more than $3 billion trying to find a way to treat Alzheimer’s disease. Its latest drug, donanemab, finally shows real promise.
Lilly shares surge after its potential Alzheimer’s drug slows cognitive decline
The experimental drug, donanemab, could be a huge breakthrough for Lilly, which has spent billions of dollars over 30 years researching treatments for Alzheimer’s disease, only to see them fall short in clinical trials.
First blood test to help diagnose Alzheimer’s goes on sale
Independent experts are leery because key test results have not been published and the test has not been approved by the U.S. Food and Drug Administration—it’s being sold under more general rules for commercial labs.
FDA panel urges rejection of experimental Alzheimer’s drug
The Biogen drug, known as aducanumab, does not cure or reverse Alzheimer’s, but it might modestly slow the rate of decline.