Search Results for “Alzheimer” – Page 5 – media

Medicare details plan to cover Alzheimer’s treatments

Medicare Part B will cover treatments for Alzheimer’s disease that receive U.S. Food and Drug Administration approval, according to the federal agency that administers the program for seniors. Anyone who has Medicare Part B and meets “eligibility criteria” will be covered for new antibody treatments such as Leqembi once the FDA approves them, said Chiquita Brooks-LaSure, the administrator of the Centers for Medicare & Medicaid Services, on Thursday. Part B is an optional part of the Medicare program for seniors that typically covers the costs of drugs patients cannot administer themselves, such as infusions. The new policy will provide broader access to treatments, such as Leqembi, that slow cognitive decline. But patients will have to participate in so-called registries that collect real-world data on how the drugs work. Brooks-LaSure said the expanded coverage will go into effect on the same day the FDA approves an Alzheimer’s antibody treatment. The FDA ...
- Source: drugdu
- 113
- June 4, 2023
Medicare holds firm on Alzheimer’s drug coverage policy

By Rachel Cohrs CMS Administrator Chiquita Brooks-LasureCHIP SOMODEVILLA/GETTY IMAGES WASHINGTON — Despite pressure from Congress and advocates, Medicare isn’t changing its coverage plan for new Alzheimer’s drugs anytime soon. Medicare on Thursday issued a statement reiterating its intent to require patient registries to collect data about how medications perform even after they gain full Food and Drug Administration approval. Eisai’s Leqembi could gain full approval within the next month, so time is running short for the agency to solidify details. Right now, Leqembi and Biogen’s Aduhelm only have accelerated approval from the FDA, and are subject to even more restrictive coverage limits that require patients to be enrolled in a clinical trial to receive the medications. If Leqembi wins full approval, those restrictions will relax slightly, but providers would still need to collect data about all patients who receive the drugs in a patient registry. Medicare had previously announced ...
- Source: drugdu
- 105
- June 3, 2023
Researchers discover novel ‘Shanghai APP’ mutation in late-onset Alzheimer’s disease

Alzheimer’s disease (AD) is a progressive neurodegenerative disorder affecting tens of millions of people worldwide, and it is the most common cause of dementia. Early-onset AD is typically associated with mutations in the genes APP, PSEN1, and PSEN2, leading to a more aggressive form of the disease with atypical symptoms. In contrast, the newly discovered “Shanghai APP” mutation has been linked to LOAD, which affects a larger population of AD patients. In a study published in Genes & Diseases, researchers from Ruijin Hospital, affiliated to Shanghai Jiao Tong University School of Medicine and other three teams detected the Shanghai APP mutation in a Chinese patient who developed memory decline in his mid-70s. Neuroimaging techniques confirmed the presence of widespread amyloid β deposition, a key hallmark of AD. Using molecular dynamics simulation and in vitro experiments, the team found that the E674Q mutation led to increased processing of APP and production of amyloid β, ...
- Source: drugdu
- 148
- May 16, 2023
Otsuka, Lundbeck’s Rexulti nabs new use in Alzheimer’s disease agitation

After Lundbeck and Otsuka’s Rexulti cleared a key advisory committee hurdle, the FDA has given the drug the go-ahead to treat dementia-associated agitation in Alzheimer’s disease patients With the approval, Rexulti becomes the first drug approved for this use in the United States. The FDA granted the nod based on data from two 12-week studies in which patients showered statistically significant and clinically meaningful improvements on the Cohen-Mansfield Agitation Inventory scale, according to the FDA. The metric looks at the frequency and intensity of dementia-related agitation. In the studies, Rexulti demonstrated a 31% improvement from baseline agitation symptoms compared with placebo. Agitation symptoms cover a wide group of behaviors including pacing, gesturing, profanity, shouting, and physical outbursts, Otsuka said in a release. The symptoms are the leading causes of assisted living or nursing room placement and have been known to be associated with accelerated disease progression, Tiffany Farchione, director ...
- Source: drugdu
- 111
- May 13, 2023
Eli Lilly’s Alzheimer’s drug shown to significantly slow disease progression in phase 3 trial

Eli Lilly’s experimental Alzheimer’s drug, donanemab, has been shown to significantly slow cognitive and functional decline in patients with early-stage disease. The phase 3 TRAILBLAZER-ALZ 2 study met its primary endpoint, with the drug slowing the progression of the disease by 35% compared to placebo in 1,182 patients with early symptomatic Alzheimer’s disease and intermediate levels of tau protein. All secondary endpoints of cognitive and functional decline were also met and showed highly statistically significant clinical benefits, the company said. Results from the trial demonstrated that 47% of patients who received donanemab showed no disease progression a year after starting treatment, compared with 29% on placebo. Additionally, 52% of patients completed their course of treatment by one year, and 72% completed by 18 months as a result of achieving amyloid plaque clearance. Patients receiving donanemab also experienced a 39% lower risk of progressing to the next stage of disease, and ...
- Source: drugdu
- 139
- May 7, 2023
Membrane lipid remodeling alters key enzyme involved in Alzheimer’s

Adding long-chain fatty acids can thicken cell membranes and alter the activity of a key enzyme, as LMU scientists have demonstrated in cell cultures. A characteristic feature of Alzheimer’s disease are deposits of the amyloid-β protein, which clumps together to form plaques in the brain. The amyloid-β protein is produced by an enzyme which resides in cellular membranes. A team lead by Prof. Harald Steiner and Dr. Edgar Dawkins from the Biomedical Center Munich at LMU has now shown that the production of amyloid-β is influenced by the membrane thickness. Cellular membranes consist of lipid bilayers. By externally adding further lipids, they can be thickened, which alters their properties. In earlier studies, Steiner’s team had already demonstrated in cell-free model systems that such changes affect the production of amyloid-β. This effect arises because the key enzyme for the production of amyloid-β, the so-called γ-secretase, is localized inside ...
- Source: drugdu
- 122
- May 6, 2023
Medicare will cover Leqembi for all patients if FDA approves drug, CMS chief says

Medicare will cover the new Alzheimer’s treatment Leqembi for all patients eligible under the medication’s label if the Food and Drug Administration fully approves the drug in July, a federal official told members of Congress on Wednesday. The official, Chiquita Brooks-LaSure testified before Congress Wednesday for the first time since her confirmation as administrator of the Centers for Medicare and Medicaid Services. Brooks-LaSure faced pointed criticism from Democrat and Republican members of the House Subcommittee on Health over Medicare’s controversial coverage policy for new Alzheimer’s treatments. The Food and Drug Administration approved Leqembi, which is a collaboration by Biogen and Eisai antibody treatment, on an expedited basis in January. Twice-monthly intravenous infusions of the drug, generically known as lecanemab, have shown promise in slowing the progression of early Alzheimer’s disease. But Medicare, which primarily provides health coverage to senior citizens, currently will only cover the ...
- Source: drugdu
- 119
- May 1, 2023
Spherix

U.S. neurologists are “cautiously optimistic” about using Eisai’s Leqembi in Alzheimer’s disease as concerns about safety and the need for the FDA’s full green light for the drug remain high barriers to uptake. That’s according to a new survey and report out by drug launch analyst Spherix Global Insights, which in March asked 73 neurologists working in the U.S. about their use and receptivity of Leqembi, which was partially approved by the FDA at the start of the year. Now launched, the drug finds itself at a strange junction. It still does not have a full FDA approval; that isn’t set to come until early July. While there is another new drug on the market for Alzheimer’s—namely Aduhelm, which Eisai helped create with Biogen—that drug is commercially dead in the water. The Centers for Medicare & Medicaid Services (CMS) refused to cover payments of Aduhelm, which was ...
- Source: drugdu
- 133
- April 14, 2023
FDA approves controversial new Alzheimer’s drug

On April 4th, 2023, Pharmaceutical Technology reported that the FDA has approved a new treatment for Alzheimer’s disease called Aduhelm. The drug, developed by Biogen, is the first new Alzheimer’s treatment to be approved in nearly two decades. However, the approval has been controversial, with some experts questioning the drug’s efficacy and high cost. Aduhelm targets a protein called beta-amyloid, which is believed to play a role in the development of Alzheimer’s disease. The drug has been shown to reduce the buildup of beta-amyloid in the brain, but some experts have raised concerns about the drug’s efficacy and potential side effects. The drug is also very expensive, with an estimated cost of $56,000 per year per patient. This has led some experts to question whether the drug is worth the cost. Despite the controversy, the approval of Aduhelm is seen as a significant development in the fight against ...
- Source: drugdu
- 163
- April 12, 2023
US health officials aim to ‘transform’ Alzheimer’s disease research with $300 million data platform

The US National Institute on Aging is moving forward with efforts to build a real-world Alzheimer’s disease database as part of its aim to improve, support and conduct more dementia research. Last month, the agency, part of the National Institutes of Health, posted a notice of the grant for the six-year database project, setting its earliest start date as April 2024. The NIH confirmed Tuesday that plans are underway to fund the Alzheimer’s disease and Alzheimer’s disease-related dementias’ real-world data platform. The National Institute on Aging intends to commit $50 million per year, starting in fiscal year 2024, to fund one award. The nonprofit Alzheimer’s Association is among those planning to apply for the grant. “The newly-announced NIA funding for a large-scale Alzheimer’s disease research database is truly exciting and a very important step forward for our field, and the Alzheimer’s Association will apply for ...
- Source: drugdu
- 144
- April 12, 2023

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