Clinical Overview: Lecanemab Use, Coverage for Alzheimer Disease
Pharmacy Times
SEPTEMBER 26, 2023
In clinical trials, lecanemab showed a reduction of amyloid beta plaque in patients with Alzheimer disease.
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Opinion: Alzheimer’s drug approvals show we need a reevaluation of patient advocacy
STAT
DECEMBER 18, 2023
When faced with a loved one’s progressive neurodegenerative disease, like Alzheimer’s, or your child’s rare respiratory disease, you question why researchers and resource-backed pharma cannot bring a drug to market quickly enough to help your loved ones.
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STAT+: Years after a polarizing approval, Biogen walks away from Aduhelm
STAT
JANUARY 31, 2024
Biogen is giving up its ownership of Aduhelm , the Alzheimer’s disease treatment whose 2021 approval led to scrutiny and outrage, turning the page on a tempestuous chapter in the company’s long history.
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STAT+: Cassava pulled back the curtain on its Alzheimer’s study — and revealed insurmountable problems
STAT
OCTOBER 30, 2023
Cassava Sciences has long claimed its experimental drug, called simufilam, slows the cognitive decline of people with Alzheimer’s. On Friday, we learned how: The company recruited a large number of people into its clinical trial who don’t have Alzheimer’s.
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STAT+: Under-the-skin injection of Eisai’s Leqembi is as effective as IV infusion, new Alzheimer’s data show
STAT
OCTOBER 25, 2023
A version of the Alzheimer’s disease drug Leqembi that can be given with a simpler, under-the-skin injection is equally effective as the currently approved intravenous infusion, according to study results presented Wednesday by its maker, Eisai. Continue to STAT+ to read the full story…
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STAT+: Alzheimer’s researchers try out an unfamiliar sensation: optimism
STAT
DECEMBER 2, 2022
SAN FRANCISCO — Scientific meetings about Alzheimer’s disease can be funereal affairs, with researchers from around the world gathering in hopes that the latest in a long line of negative clinical trials might light the path to a long-awaited success. This year was different.
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Opinion: Manufacturers need to be more open about a dangerous Alzheimer’s drug side effect
STAT
NOVEMBER 28, 2023
Since the FDA’s approval of lecanemab (marketed as Leqembi) and Medicare’s recent decision to cover the drug, I have met with Alzheimer’s patients and their loved ones who are anxious to know whether they may benefit from this new treatment. Read the rest…
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STAT+: Detailed data confirm benefits — and risks — of Eli Lilly’s Alzheimer’s drug
STAT
JULY 17, 2023
The benefits and risks of Eli Lilly’s treatment for Alzheimer’s disease were confirmed in detailed scientific disclosures Monday, paving the way for its full approval but leaving physicians with lingering questions about the medicine’s impact on patients as a new era in Alzheimer’s therapy unfolds.
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STAT+: FDA panel unanimously endorses Eisai’s Alzheimer’s drug
STAT
JUNE 9, 2023
Expert advisers to the Food and Drug Administration on Friday voted unanimously in favor of expanding the approval of Leqembi, an Alzheimer’s disease treatment from Eisai and Biogen, further clearing the way for what could be the first widely available medicine that delays the disease’s progress.
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STAT+: Medicare to cover more brain scans related to Alzheimer’s drugs
STAT
OCTOBER 13, 2023
Medicare has officially expanded its coverage policy for brain scans that detect a brain plaque associated with Alzheimer’s disease, the agency announced on Friday. Previously, Medicare limited coverage for the drug to patients enrolled in clinical studies, and only covered one scan in a patient’s lifetime.
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STAT+: Detailed data on Alzheimer’s therapy from Eisai, Biogen hold up to scientific scrutiny
STAT
NOVEMBER 29, 2022
SAN FRANCISCO — A closely watched new treatment for Alzheimer’s disease held up to scrutiny in a detailed scientific presentation Tuesday, as its developers, partners Eisai and Biogen, begin the lengthy process of turning this medicine into what they hope could be a groundbreaking therapy.
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US FDA to Review Eli Lilly’s Donanemab for Early Alzheimer’s Treatment
Express Pharma
MAY 8, 2024
The US Food and Drug Administration (FDA) will convene an in-person meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) on Monday, June 10, 2024, to discuss donanemab, which Eli Lilly and Company (NYSE: LLY) has submitted for the treatment of early symptomatic Alzheimer’s disease.
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Don’t ignore potential microbial causes of Alzheimer’s and other chronic diseases, researchers say
STAT
MAY 3, 2023
The conversation on Wednesday centered around decades of evidence linking herpes simplex virus type 1, or HSV-1, to Alzheimer’s. The conversation on Wednesday centered around decades of evidence linking herpes simplex virus type 1, or HSV-1, to Alzheimer’s. Read the rest…
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STAT+: Drug firms test medicines to halt Alzheimer’s before symptoms appear
STAT
AUGUST 31, 2023
Alzheimer’s disease has killed at least three women in Astrida Schaeffer’s family over two generations, leaving her feeling helpless and bereft. Last year, the disease killed Schaeffer’s mother’s sister, a former lab technician for Johnson & Johnson. She died in 2019.
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STAT+: Burning questions left unanswered about the latest Alzheimer’s therapy
STAT
SEPTEMBER 29, 2022
News of the first clearly successful clinical trial for a new Alzheimer’s disease treatment in two decades has brought hope, scrutiny, and skepticism to a field accustomed to disappointment. Continue to STAT+ to read the full story…
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STAT+: FDA approves first Alzheimer’s therapy shown to clearly slow cognitive decline
STAT
JULY 6, 2023
The Food and Drug Administration on Thursday granted full approval to the first therapy for Alzheimer’s disease clearly shown to slow the cognitive decline associated with the disease — a milestone in treatment, even if the benefits are modest. Continue to STAT+ to read the full story…
STAT+: What to know about Roche’s experimental Alzheimer’s treatment
STAT
OCTOBER 17, 2022
The next big Alzheimer’s disease study readout is almost here. Roche is nearing the completion of a pair of clinical trials involving its experimental treatment called gantenerumab. The Swiss pharma giant will announce results from the studies within the next six weeks. Continue to STAT+ to read the full story…
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STAT+: Roche’s experimental Alzheimer’s treatment fails to slow cognitive decline across two clinical trials
STAT
NOVEMBER 13, 2022
Roche reported negative results Monday from a pair of clinical trials investigating an antibody treatment for people with early-stage Alzheimer’s disease — another setback for the Swiss pharma giant’s decades-long effort to develop medicines against the memory-destroying disease.
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Listen: Lilly’s Alzheimer’s success, a milestone FDA approval, & Moderna’s shrinking business
STAT
MAY 4, 2023
What’s the future of Alzheimer’s disease treatment? Eli Lilly’s investigational medicine for Alzheimer’s met its goals in an all-important clinical trial, and we explain the results, their implications, and the backstory of what could be a blockbuster drug. How do you pivot from a pandemic?
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Alzheimer’s treatment slowed cognitive decline in closely watched clinical trial
STAT
SEPTEMBER 28, 2022
An investigational Alzheimer’s disease treatment from Biogen and Eisai slowed the rate of cognitive decline by 27% in a clinical trial, the companies said Tuesday, meeting the goals of a closely tracked study and strengthening the drug’s case for approval as early as January.
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STAT+: It’s time for the FDA to halt Cassava Sciences’ Alzheimer’s clinical trials
STAT
OCTOBER 17, 2023
The Food and Drug Administration should halt Cassava Sciences’ ongoing clinical trials in Alzheimer’s disease. The FDA has the power to place clinical holds on experimental drugs when there’s evidence of an unacceptable safety risk to study participants. Simufilam doesn’t appear to be toxic.
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STAT+: Alzheimer’s clinical trials have a recruitment problem. Telehealth platform Ro thinks it can helpÂ
STAT
OCTOBER 6, 2022
Telehealth company Ro has reached an agreement with the National Institute on Aging to create a registry of patients that could participate in Alzheimer’s disease research, a new approach to tackle the stubborn issue of recruitment for clinical trials. Continue to STAT+ to read the full story…
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Eisai and Biogen’s latest Alzheimer’s drug needs to be cheaper than the last one, analysts say
STAT
DECEMBER 22, 2022
The latest Alzheimer’s disease treatment from Eisai and Biogen needs to be cheaper than $20,000 a year to be cost-effective, according to a draft analysis from an influential nonprofit organization published Thursday. Read the rest…
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Gantenerumab Not Found to Slow Clinical Decline in Early Alzheimer Disease
Pharmacy Times
NOVEMBER 17, 2022
Patients with Alzheimer disease administered gantenerumab did experience slower clinical decline, however, it was not deemed statistically significant.
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Listen: A surprise success in Alzheimer’s and how FDA history seeded modern controversy
STAT
SEPTEMBER 30, 2022
Does the latest Alzheimer’s disease drug actually work? Lecanemab, a new Alzheimer’s treatment from partners Biogen and Eisai, succeeded in a pivotal clinical trial, and we explain the surprising development and its sweeping implications. When does the FDA call in security?
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An Alzheimer’s therapy scores winning results, but what could it mean for patients?
STAT
SEPTEMBER 29, 2022
The news Tuesday night that a clinical trial of an experimental Alzheimer’s therapy had succeeded hit like a blast — at last, a rare win in a disease devastating nearly 6 million Americans and countless more caregivers. That finding was based on a.45-point Read the rest…
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STAT+: An Anavex study spin job sullies an otherwise spectacular Alzheimer’s conference
STAT
DECEMBER 2, 2022
Anavex Life Sciences said Thursday that its experimental treatment for Alzheimer’s disease slowed the rate of cognitive decline in a clinical trial — but only by changing the study’s primary efficacy goals, omitting patients from the analysis, randomly altering data, making basic math errors, whistling past safety concerns, and (..)
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STAT+: Pharmalittle: Roche Alzheimer’s drug fails in two studies; Indivior bets on addiction market with deal to buy Opiant
STAT
NOVEMBER 14, 2022
… Roche reported negative results from a pair of clinical trials investigating an antibody treatment for people with early-stage Alzheimer’s disease — another setback for its decades-long effort to develop medicines against the memory-destroying disease , STAT writes.
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STAT+: Pharmalittle: Data confirm benefits and risks of Lilly Alzheimer’s drug; Medicare aims to pay hospitals to stockpile essential drugs
STAT
JULY 18, 2023
… The benefits and risks of an Eli Lilly treatment for Alzheimer’s were confirmed in detailed scientific disclosures Monday, paving the way for its full approval but leaving physicians with lingering questions about the medicine’s impact on patients as a new era in Alzheimer’s therapy unfolds , STAT says.
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STAT+: Pharmalittle: Detailed data on Alzheimer’s drug hold up to scrutiny; Horizon in takeover talks with three pharma giants
STAT
NOVEMBER 30, 2022
… A closely watched new treatment for Alzheimer’s disease held up to scrutiny in a detailed scientific presentation, as Eisai and Biogen begin the lengthy process of turning the medicine into what they hope could be a groundbreaking therapy , STAT writes. Continue to STAT+ to read the full story…
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STAT+: Pharmalittle: Medicare looks to improve Alzheimer’s care but sidesteps drug prices; CVS to cut 5,000 jobs
STAT
AUGUST 1, 2023
… Medicare announced a pilot program aimed at improving dementia care and reducing the strain on unpaid caregivers, but it does not deal with controlling the price of new Alzheimer’s drugs , STAT writes. billion deal for Oak Street Health, which operates primary-care clinics for the elderly. The pilot is voluntary.
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Clinical Overview: Comparison of Anti-Amyloid Monoclonal Antibodies for Alzheimer Disease
Pharmacy Times
OCTOBER 11, 2023
Aducanumab, lecanemab, and donanemab are novel monoclonal antibodies designed to slow disease progression and hopefully have a positive impact in the field of Alzheimer disease management.
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Clinical Overview: Lecanemab Offers Hope for Patients With Alzheimer Disease
Pharmacy Times
OCTOBER 17, 2023
Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody that targets amyloid plaques, which are thought to play a role in the development and progression of Alzheimer disease.
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STAT+: Pharmalittle: Biogen Alzheimer’s drug slowed cognitive decline in a trial; European pharma warns energy costs may halt some generic production
STAT
SEPTEMBER 29, 2022
… An investigational Alzheimer’s disease treatment from Biogen and Eisai slowed the rate of cognitive decline by 27% in a clinical trial, meeting the goals of a closely tracked study and strengthening the case for regulatory approval as early as January , STAT reports. The
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Exploring new avenues to treat Alzheimer’s
Express Pharma
MARCH 10, 2024
Parkinson’s, Alzheimer’s Disease, Epilepsy, Stroke, Autism, etc. Alzheimer’s disease is the sixth-leading cause of death worldwide. Alzheimer’s disease is the sixth-leading cause of death worldwide. The three main types of AD include early-onset Alzheimer’s reported before the age of 60.
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Opinion: Support family caregivers to improve and diversify clinical trials
STAT
OCTOBER 21, 2022
The clinical trial enterprise, however, has yet to appreciate caregivers — and fully engage them — as critical partners in recruiting and supporting people who are older, disabled, or have Alzheimer’s disease, cancer, or other chronic medical conditions for research studies.
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STAT+: Pharmalittle: Pharmacies are battlegrounds in the abortion debate; Lilly Alzheimer’s drug failed to prevent memory loss in study
STAT
MARCH 9, 2023
… An experimental Eli Lilly drug failed to prevent memory loss in a study of healthy older people with a high risk of developing clinical Alzheimer’s disease in one of the first studies aimed at stopping symptoms before they start, The Wall Street Journal writes.
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STAT+: Pharmalittle: Some employers cut insurance coverage for weight loss drugs; U.S. urges ADHD pill makers to boost production
STAT
AUGUST 2, 2023
The first drug purporting to slow the advance of Alzheimer’s disease is likely to cost the U.S. taxpayers $82,500 per patient per year, on average, for genetic tests, frequent brain scans, safety monitoring, and other care, according to the Institute for Clinical and Economic Review, or ICER.
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Sildenafil (Viagra) as a candidate drug for Alzheimer's disease
World Pharma News
MARCH 5, 2024
New Cleveland Clinic-led research points to sildenafil (Viagra) as a potential treatment for Alzheimer's disease. The study provides evidence from computational models, insurance claims data and observations from brain cells in Alzheimer's patients.
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Eisai's Lecanemab phase 3 study meets primary endpoint
Pharma Times
SEPTEMBER 29, 2022
Results show reduction of clinical decline in global study of people with Alzheimer's Disease
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Brexpiprazole Demonstrates Clinically Meaningful Improvements for Agitation Due to Alzheimer Disease
Pharmacy Times
NOVEMBER 7, 2023
In May 2023, the FDA approved brexpiprazole as the first and only drug to receive approval for treatment of agitation associated with Alzheimer Disease dementia.
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Eisai submits MAA for lecanemab in Great Britain to treat early Alzheimer’s disease
Express Pharma
MAY 22, 2023
The MAA is based on the results of the confirmatory Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD, and is subject to validation to determine whether it will be accepted by the MHRA.
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STAT+: Pharmalittle: Medicare plans sizable infrastructure for negotiating drug prices; Alzheimer’s data also boost Roche and Lilly
STAT
SEPTEMBER 30, 2022
… The results of a key Alzheimer’s drug trial on Wednesday have reignited decades-old hopes that targeting amyloid beta helps arrest the progression of the fatal brain disease, giving a big boost to similar studies being run by Roche and Eli Lilly , Reuters explains. Meanwhile, keep in touch.
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AbbVie to buy neuroscience specialist Cerevel Therapeutics for $8.7bn
European Pharmaceutical Review
DECEMBER 8, 2023
Cerevel’s pipeline includes multiple clinical-stage and preclinical candidates with potential across several diseases including schizophrenia, Parkinson’s disease, and mood disorders. Gonzalez, chairman and chief executive officer of AbbVie. AbbVie also agreed a $10.1
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