Search Results for “Alzheimer” – Page 4 – media

Sales of Alzheimer’s Drug Leqembi may be Slow Initially But Could Pick up in 2024

Sales of the Alzheimer’s drug Leqembi may be slow initially due to logistical requirements but could pick up in 2024, analysts said after the groundbreaking treatment won approval in the U.S. Wall Street is chewing over the Food and Drug Administration’s Thursday approval of Leqembi – a milestone in the treatment of the disease, even though the drug isn’t a cure. Leqembi, from drugmakers Eisai and Biogen, is the first medicine proven to slow the progression of Alzheimer’s in people at the early stages of the memory-robbing disease. Medicare on Thursday announced it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, broadening access for those who can’t afford the drug’s hefty $26,500-a-year price tag. But coverage comes with several conditions. Analysts believe certain Medicare requirements and new guidance on Leqembi’s prescription label could potentially weigh on sales of the ...
- Source: drugdu
- 118
- July 11, 2023
New program offers hiking adventures for people with younger-onset Alzheimer’s

Starting this July, people diagnosed with Alzheimer’s before age 65 will have a new opportunity to connect with others while exploring the great outdoors through a program called SOAR. The name is an acronym for Shared Outdoor Adventures for Resilience. Offered by the UW Medicine Memory and Brain Wellness Center, SOAR will feature free monthly hikes in the Puget Sound area for small groups of people with younger-onset Alzheimer’s. Each participant brings along a family member or friend. A lifelong recreation specialist from Seattle Parks and Recreation will lead the hikes. Optional transportation is provided. Hikes will be up to 3 or 4 miles. The type of terrain will vary among the different hikes to provide a challenge but still be accessible to a wide range of participants. Volunteer naturalists will join periodically to talk about plants and animals in the region. SOAR will conclude with a nature retreat at ...
- Source: drugdu
- 117
- July 10, 2023
FDA grants traditional approval for Eisai-Biogen’s Alzheimer’s therapy

The US Food and Drug Administration (FDA) has granted traditional approval for Eisai and Biogen’s Leqembi (lecanemab-irmb) 100mg/mL injection to treat Alzheimer’s disease (AD) in adults. With the approval of the supplemental biologics licence application (sBLA), Leqembi becomes the first therapy to slow disease progression rate and cognitive and functional decline in AD patients. This development is based on findings from the Phase III portion of Eisai’s Clarity AD clinical trial. Trial data showed that the product met the Leqembi primary endpoint and all crucial secondary endpoints, and also demonstrated clinical benefit. In January 2023, the regulatory agency granted accelerated approval for Leqembi. Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble (protofibril) and amyloid beta’s (Aβ) insoluble forms. Eisai CEO Haruo Naito stated: “The FDA approved Leqembi under the traditional approval pathway, making Leqembi the first and only approved anti-amyloid Alzheimer’s disease treatment shown ...
- Source: drugdu
- 110
- July 9, 2023
With full Alzheimer’s approval in hand, Eisai and Biogen kick off Leqembi’s launch in earnest

It’s official: Roughly half a year after the FDA granted an accelerated nod to Eisai and Biogen’s new Alzheimer’s disease med lecanemab, the companies have converted that green light into a full-fledged, traditional approval. Now, the drug—also known as Leqembi—is set to unshackle itself from a strict coverage determination by the Centers for Medicare & Medicaid services (CMS). With a full approval in hand, Leqembi has become the first treatment shown to reduce the rate of disease progression and slow cognitive and functional decline in adults with Alzheimer’s under the traditional approval pathway, Eisai Executive Vice President Alex Scott, who oversees government affairs, said in an interview. Those benefits stand across a “broad patient group that’s generalizable to the whole Medicare population,” he added. Leqembi won an accelerated FDA approval in January based on its ability to reduce amyloid beta plaque, a marker of Alzheimer’s disease that’s believed to be ...
- Source: drugdu
- 112
- July 8, 2023
Fluctuating blood lipid levels linked with higher risk of Alzheimer’s disease, study finds

By Kristen Rogers, CNN Having a fluctuating cholesterol level has been linked with higher risk of Alzheimer’s disease, a new study has found. coldsnowstorm/iStockphoto/Getty Images Editor’s Note: Sign up for CNN’s Eat, But Better: Mediterranean Style. Our eight-part guide shows you a delicious expert-backed eating lifestyle that will boost your health for life. CNN — The fact that having high cholesterol can cause health problems is well known. But a total cholesterol level that fluctuates a lot — either up or down within a five-year period — might also be problematic by raising the risk of later dementia, a new study found. “This study adds to a growing body of evidence showing that addressing certain modifiable risk factors and promoting healthy behaviors can reduce the risk of cognitive decline, possibly reduce the risk of dementia, and protect cognitive health,” said Christopher Weber, director of global science initiatives at the ...
- Source: drugdu
- 117
- July 7, 2023
Missed trial protocols, fabricated emails and failed endpoint mar BioXCel’s Alzheimer’s agitation readout

A new treatment for Alzheimer’s disease agitation episodes might be on the horizon, but a principal trial investigator skirting protocol could muddy the waters. As BioXCel unveiled its phase 3 data for its orally dissolving dexmedetomidine (originally Pfizer’s Precedex) formulation in Alzheimer’s-related agitation, the company also disclosed some serious trial missteps in an Securities and Exchange Commission (SEC) filing. After the FDA in December inspected a trial site that enrolled about 40% of study participants, the agency found three big red flags relating to adherence of the trial’s framework, the filing says. For one, the investigator failed to follow the informed consent plan for four trial subjects, chief medical officer Robert Risinger, M.D., told investors on a conference call. In “certain instances” the investigative plan wasn’t followed and sufficient case histories weren’t maintained for some patients. For example, the site reported a serious adverse event for one patient outside of ...
- Source: drugdu
- 106
- July 2, 2023
BioXcel’s Positive Alzheimer’s Agitation Data Overshadowed by Principal Investigator Fabrications

By David Adam Pictured: Person holding a cell phone in front of computer with stock data/iStock The release of positive topline results Thursday from the Phase III trial of BioXcel Therapeutics’ Alzheimer’s-related agitation treatment was overshadowed by disclosures to the SEC about fabricated email correspondences pertaining to the study’s safety data. In a Thursday SEC filing, BioXcel said that a trial site’s principal investigator—who enrolled 40% of the study participants at that site—was found to have fabricated email correspondences related to the timing of the filing for a serious adverse event (SAE) with the company’s vendor responsible for the monitoring of drug safety. The adverse event occurred in a subject in the placebo arm, the company said. In May 2023, it “came to the company’s attention that this same principal investigator in the TRANQUILITY II clinical trial may have fabricated email correspondence purporting to demonstrate that the investigator timely submitted ...
- Source: drugdu
- 108
- July 1, 2023
Eisai, Biogen’s Alzheimer’s disease drug Leqembi passes muster at FDA adcomm

After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen’s Leqembi is heading into the final stretch of its regulatory review on strong footing.During a Friday meeting, members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee took a careful look at the data behind the partners’ Alzheimer’s disease drug. Ultimately, the group voted 6 to 0 that the drug’s Clarity AD study verify its clinical benefit. In the discussion portion of the meeting, advisory committee members described the trial results as “robust,” “meaningful,” “consistent” and “significant.” Now, it’s up to the FDA to decide whether to follow the advisory committee’s guidance. The agency is expected to decide on the application by July 5. Before the Friday discussion, the FDA released its own briefing document that appeared to outline agency support for a full approval. During the meeting, the FDA’s acting director of the ...
- Source: drugdu
- 113
- June 13, 2023
Axol and StrataStem link up for Alzheimer’s disease trial

Companies will incorporate cells and technology to create a ‘clinical trial in a dish’ Axol Bioscience – a stem cell technology provider – has reached an agreement with StrataStem to access and commercialise its collection of Alzheimer’s disease (AD) patient samples. Under the terms, Axol will reprogramme the samples into ‘induced pluripotent stem cells’ (iPSCs) that can subsequently be separated into an extensive range of brain cells. These include neurons and neuroinflammatory cells. Formed in vitro, the cells can provide patient-specific human brain models from a cohort of AD patients, ultimately creating a ‘clinical trial in a dish’. The research concentrates on sporadic AD (sAD) – the most prevalent form of the disease, accounting for over 95% of all cases. sAD has no specific family link and is triggered by a combination of genetics, the environment and an individual’s lifestyle. Meanwhile, StrataStem’s collection of donor materials, including blood samples and ...
- Source: drugdu
- 127
- June 10, 2023
Lawmakers worry Medicare Alzheimer’s plan won’t ensure access to new treatments

Two Democratic lawmakers are calling on Medicare to provide more information on how the program will make good on its promise to cover Alzheimer’s treatments for seniors. Rep. Anna Eshoo, the ranking Democrat on the House Subcommittee on Health, and Rep. Nanette Barragan said Medicare has failed to answer basic questions about how its coverage plan will work. The lawmakers told Chiquita Brooks-LaSure, who heads the Centers for Medicare and Medicaid Services (CMS), in a letter Monday that it is still “very unclear” how seniors will access the new treatments. Medicare has promised to cover Alzheimer’s antibody treatments on the same day the medications receive full approval by the Food and Drug Administration. The federal health program will cover the treatments through Part B of the program for seniors. Part B typically covers treatments that seniors can’t administer at home on their own, such as infusions. Under this policy, seniors ...
- Source: drugdu
- 168
- June 8, 2023

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