Acadia Pharmaceuticals intends to again request that oral Nuplazid (pimavanserin) be approved to treat hallucinations and delusions, but this time only when associated with the dementia-related psychosis of Alzheimer’s disease. Its planned request to the U.S. Food and Drug Administration (FDA), in the form of a resubmitted supplemental new drug application (sNDA), follows the FDA’s rejection last year of…
Conditions
Conditions
Alzheimer Society of Canada Programs Are ‘First Link’ of Support
To ensure that dementia patients and their caregivers have proper support and information, the Alzheimer Society of Canada is calling attention to its First Link program, designed to share a key message: “You are not alone.” The Canada-wide campaign, announced in January during the country’s Alzheimer’s Awareness Month, seeks to remind those with dementia or…
Janssen Seeks FDA Approval of Teclistamab for RRMM
Janssen is seeking the approval of its investigational therapy teclistamab in the U.S. for people with relapsed or refractory multiple myeloma (RRMM). “Despite all the gains that have been made in treating multiple myeloma, the unmet need still remains very high,” Peter Lebowitz, MD, PhD, global therapeutic area head of oncology at Janssen research and…
Clinical Trial Set for Gantenerumab in Early-onset Alzheimer’s Disease
An international clinical trial for gantenerumab aimed at preventing inherited, early-onset Alzheimer’s disease is being launched at the Washington University School of Medicine in St. Louis. The trial, called the Primary Prevention Trial, is enrolling people with a family history of early-onset Alzheimer’s and its associated genetic mutations up to 25 years before their expected onset…
Proposal That Medicare Covers Aduhelm Only for Trials Sparks Outrage
A new proposal in the U.S. that Medicare cover the cost of Aduhelm (aducanumab) only for people enrolled in qualifying clinical trials has been met with outrage from the Alzheimer’s Association and decried by Biogen, which developed the treatment alongside Eisai. Issued by the U.S. Centers for Medicare and Medicaid Services (CMS), the proposed National…
Rethink-ALZ.com, New Website on Simufilam Phase 3 Studies, Is Live
Cassava Sciences has launched a new website, called Rethink-ALZ.com, to make it easier for anyone interested to access information about two Phase 3 clinical studies of simufilam, the company’s oral investigational therapy for mild-to-moderate Alzheimer’s disease. The trials, dubbed RETHINK-ALZ and REFOCUS-ALZ, are ongoing in the U.S. and Canada, and both are currently recruiting patients with…
Model May Better Classify Multiple Myeloma and Relapse Risks
A model that may better classify multiple myeloma (MM) using genetic sequence data from hundreds of patients has been developed. The model can identify specific genes and genetic alterations responsible for disease subtypes related to a risk of relapse, and it may contribute to the identification of targeted therapies, according to the study’s researchers, led…
Phase 2a Trial Initiated for Lomecel-B in Mild Alzheimer’s Disease
Longeveron is initiating a Phase 2a clinical trial for its Lomecel-B treatment — an investigational, bone marrow-derived, medicinal signaling cell (MSC) — in patients with mild Alzheimer’s disease. The first patient has already given consent to participate in the trial, and further patient screening has begun. “We are pleased to have initiated this Phase 2a…
FDA Puts Hold on Plans to Start Clinical Testing of DNL919 Therapy
The U.S. Food and Drug Administration (FDA) has put a clinical hold Denali Therapeutics’ application to begin clinical testing of DNL919, an immune-modulating medication that the company is developing to treat Alzheimer’s disease. The FDA will issue an official clinical hold letter to Denali in the next month or so, according to a company press…
Stroke Therapy Candidate 3K3A-APC Holds Promise for Dementia
3K3A-APC, an investigational therapy for stroke about to enter Phase 3 clinical testing, may also help to protect the brain against Alzheimer’s disease and other forms of dementia. “Our recent and current data support development of 3K3A-APC for neurological conditions associated with cognitive dysfunction such as Alzheimer’s disease and injury to the brain’s white matter…
Japan OKs Abecma as 1st CAR T-cell for Heavily Treated Myeloma
Japan’s Ministry of Health, Labour, and Welfare has approved Abecma (idecabtagene vicleucel) as its first CAR T-cell therapy for adults with relapsed or refractory multiple myeloma who received at least three prior therapies. This includes patients treated at least with one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one CD38 inhibitor, and whose disease failed to…
NIH $2M Grant Supports Work Into Chronic Stress and Alzheimer’s
The National Institutes of Health (NIH) awarded $2 million to investigators studying how chronic physiological stress may cause vascular changes and exacerbate the cognitive decline seen in Alzheimer’s disease. Paul Chantler, PhD, an associate professor at West Virginia University School of Medicine, and his team are also using animal models to investigate how xanthine oxidase…