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…
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…
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…
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…
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…
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…
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…
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…
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…
Athira Pharma announced its Phase 2 ACT-AD trial is fully enrolled and its Phase 2/3 LIFT-AD trial has reached more than half of its target number. Both studies are evaluating the safety and efficacy of ATH-1017 in people with mild to moderate Alzheimer’s disease. Eligible adults, ages 55 to 85, are still being recruited for…
