Alzheimer’s patients and their families hear a new word: Progress
Two new drugs—including one from Indianapolis-based Eli Lilly—and better detection methods offer promise for people dealing with the disease.
Alzheimer's disease
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Nevada company sues Lilly for breach of contract over Alzheimer’s drug
Lilly called the lawsuit “baseless” and said PDL BioPharma “has no plausible claim to royalties” for donanemab, which is expected to be approved by the FDA this quarter.
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New research shows Lilly drug slows decline in Alzheimer’s patients
If U.S. regulators approve, the drug would be only the second Alzheimer’s treatment convincingly shown to delay the mind-robbing disease—after rival Leqembi. Both drugs pose a serious safety concern—brain swelling and bleeding.
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Eli Lilly says experimental drug slows decline from Alzheimer’s
If approved, Donanemab has annual multi-billion-dollar sales potential. Lilly shares rose 6% in early-afternoon trading.
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Lilly’s older Alzheimer’s drug fails to prevent disease in trial
Eli Lilly said the study concludes its clinical development of solanezumab, apparently shutting the door on one of the most closely watched experimental drugs over the past decade.
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Articles
Novo’s diabetes drug shows mixed results in Alzheimer’s trial
Victoza yielded mixed results in a mid-stage study of Alzheimer’s disease, failing to meet its primary goal while showing hints that larger trials of similar drugs may be successful.
Blood tests for Alzheimer’s might be coming to your doctor’s office.
Researchers reported Sunday that new blood tests were 91% accurate in detecting Alzheimer’s disease, far more accurate than a diagnosis from primary care doctors and specialists.
UPDATE: FDA approves Lilly drug that can modestly slow Alzheimer’s disease
Eli Lilly’s drug—Kisunla, the brand name for donanemab—is one of the few treatments developed for Alzheimer’s that modifies the underlying disease and will join just one other drug, Leqembi, on the commercial market.
Lilly hopes for positive FDA news on Alzheimer’s drug as stock sets new high
Lilly officials have said they are “incredibly confident” in the drug’s potential and the fact that it “offers very meaningful benefits to people with early symptomatic Alzheimer’s disease.”
Lilly girding for questions over Alzheimer’s treatment from FDA committee
The U.S. Food and Drug Administration is convening a panel of independent experts on June 10 to discuss donanemab’s safety and effectiveness, including the results in patients in a clinical trial.
Lilly, Roche to get expedited FDA review for blood test to diagnose Alzheimer’s disease
Roche and Lilly said they believe the test could play an important role in improving access to early and accurate Alzheimer’s diagnosis.
FDA delays Alzheimer’s drug for further review in surprise move
The call for additional scrutiny surprised Lilly executives, who noted that it is unusual for such a review to occur after the FDA has given an anticipated date to make a decision on approval. An OK for the drug had been expected this month.
Flu shots might lower risk of Alzheimer’s, related dementias
A number of studies have found that people receiving vaccinations for flu and several other infectious diseases appear less likely than the unvaccinated to develop dementia, although scientists aren’t sure why.
Alzheimer’s caregivers watching closely as drugs finally hit market
More than 110,000 Hoosiers suffer from Alzheimer’s disease, which robs people of their memories and abilities to do daily tasks, and is the nation’s sixth-leading cause of death.
Medicare to expand coverage for new class of costly Alzheimer’s drugs
Groups such as the Alzheimer’s Association have pushed Medicare to cover the new Alzheimer’s drugs—including those cleared on an expedited basis—saying that the FDA should be the final arbiter of safety and efficacy of drugs.
IU School of Medicine lands $215M in NIH funding, just shy of another record
Five of the top 10 research studies that received the most NIH funding at the medical school were for Alzheimer’s disease or brain aging, one of the school’s top priorities.
Feds reject Lilly’s fast-track application for Alzheimer’s drug
Donanemab’s ability to rapidly remove amyloid beta from patients’ brains prevented the required number of patients from receiving the drug for a full 12 months, Lilly said, resulting in the FDA rejection.
Alzheimer’s drug that modestly slows disease OK’d by FDA
It’s the first drug that’s been convincingly shown to slow the decline in memory and thinking that define the disease. But the medication comes with downsides, including potentially serious side effects and the need for frequent drug infusions.
Probe: Alzheimer’s drug approval ‘rife with irregularities’
The Food and Drug Administration’s contentious approval of Alzheimer’s drug Aduhelm took another hit Thursday as congressional investigators questioned the integrity of the process.
Drug slows Alzheimer’s, but can it make a real difference?
An experimental Alzheimer’s drug modestly slowed the brain disease’s inevitable worsening, researchers reported Tuesday—but it remains unclear whether that will have an impact on people’s lives.
Roche’s Alzheimer’s drug fails in fresh blow to fraught field
Gantenerumab’s demise is a boost for Indianapolis-based Eli Lilly and Biogen, which are also developing treatments for Alzheimer’s, said Tim Anderson, an analyst at Wolfe Research. Lilly shares were up 1.8% at midday.
IU School of Medicine researchers study mouse brains to learn about Alzheimer’s
The IU School of Medicine announced won a five-year, $48.8 million grant from the National Institute on Aging, a division of the National Institutes of Health, to create in mice genetic mutations similar to those found in people with late-onset Alzheimer’s.
IU medical school wins $49M grant to continue Alzheimer’s studies
The money will be used to study animal models of late-onset Alzheimer’s disease as well as perform rigorous testing of potential therapeutics in animals.
Experimental Alzheimer’s drug slows cognitive decline in trial, firms say
The upbeat news served as a stark contrast to the calamitous rollout last year of another drug, marketed as Aduhelm, sponsored by the two companies.