To honor their grandmother who died from Alzheimer’s in 2011, two sisters have written a children’s book to explain to kids what the disease is and how it affects those who have it. Tanya Iovino and Kiki Kouris wrote “A Kids Book About Alzheimer’s” to provide support and information to people who have a family…
Conditions
Conditions
Cilta-cel Approval Requested in Japan for Heavily-treated Myeloma
Janssen has submitted an application to regulators in Japan seeking the approval of ciltacabtagene autoleucel, an investigational CAR T-cell therapy also known as cilta-cel, to treat relapsed or refractory multiple myeloma patients. The submission to the Japanese Ministry of Health, Labour and Welfare (MHLW) specifically asks that cilta-cel be approval for patients who received at…
First Patient Dosed in Phase 1 Trial of Protollin for Early Alzheimer’s
I-Mab Biopharma announced that the first patient has been dosed in the U.S.-based Phase 1 trial of its intranasal immunotherapy agent Protollin — an investigational medication being developed to treat those with early Alzheimer’s disease. The U.S. Food and Drug Administration approved the company’s request for this safety and early efficacy study in July. “This is an…
Alzheimer’s Research UK Welcomes Pro Soccer’s Plan for Brain Health
Alzheimer’s Research UK said it “welcomes” a plan by the Football Association (FA) and other soccer governing entities to better understand and promote brain health in English football, calling the new efforts to protect players “a step forward.” In addition to the Football Association’s research task force, the joint action plan was produced by the…
‘No’ Recommendation for Aduhelm in EU; Biogen to Seek Re-exam
The Committee for Medicinal Products for Human Use, or CHMP, is recommending that Aduhelm (aducanumab) should not be approved to treat the early stages of Alzheimer’s disease. The CHMP, which is part of the European Medicines Agency (EMA), voted against recommending Aduhelm last month, and now has issued its formal ruling. The decision comes despite…
Xpovio Conditionally Approved in China for Heavily Treated Patients
China’s National Medical Products Administration (NMPA) has conditionally approved a combination of Xpovio (selinexor) and the corticosteroid dexamethasone to treat adults with relapsed or refractory multiple myeloma (RRMM) who received at least three prior therapies. This includes patients whose disease failed to respond to at least one immunomodulatory agent (IMiD), one proteasome inhibitor (PI), and…
Phase 3 Program Will Continue to Assess BXCL501 to Treat Agitation
BioXcel Therapeutics has launched a pivotal Phase 3 trial program to continue to evaluate BXCL501, its oral experimental candidate for the treatment of agitation in patients with Alzheimer’s disease. The new program consists of two clinical trials — TRANQUILITY II and TRANQUILITY III — and will assess the safety and efficacy of BXCL501 in adults…
ANVS401 Lessens Protein Buildup, Improves Cognition, Data Show
Annovis Bio’s oral therapy ANVS401 lessened the accumulation of toxic forms of amyloid-beta and tau protein — two hallmarks of Alzheimer’s disease — and led to significant improvements in cognition in patients with early Alzheimer’s, data from a Phase 2a study show. Moreover, ANVS401 levels in the blood were in agreement with previous studies and the…
Aduhelm Developers Step Up Phase 4 Confirmatory Study
Biogen and Eisai are stepping up their Phase 4 post-marketing confirmatory study to verify that Aduhelm (aducanumab) is meeting the expected clinical benefit in patients with early-stage Alzheimer’s disease. The companies plan to submit the study’s final protocol for review to the U.S. Food and Drug Administration (FDA) in March. The study will be aiming to…
Alzheimer’s Association Welcomes Aduhelm Price Cut, But Presses On
While calling the recent decision to slash by about half the U.S. list price for Aduhelm (aducanumab) an “important step,” the Alzheimer’s Association continues to advocate for more equitable access to the first new Alzheimer’s therapy since 2003. Specifically, the organization is calling for Biogen, which with Eisai developed and markets Aduhelm, to extend support to early-stage patients whose…
Top 10 Alzheimer’s Disease Stories of 2021
Alzheimer’s News Today brought you coverage of the latest scientific advances, developments in treatment, and clinical trials related to Alzheimer’s disease throughout 2021. We look forward to continuing to report important news for the Alzheimer’s community this year. Here are the top 10 most-read Alzheimer’s stories of 2021. No. 10 – “1st Phase 3 Simufilam Trial…
Lecanemab for Early Alzheimer’s Granted the FDA’s Fast Track Status
Lecanemab, an investigational antibody also known as BAN2401, has been granted a fast track designation from the U.S. Food and Drug Administration (FDA), which may help speed up its development for the treatment of early Alzheimer’s disease. The antibody, developed jointly by Biogen and Eisai, is designed to bind to the protein amyloid-beta. This potentially…