Neuralink is recruiting participants — including people with amyotrophic lateral sclerosis (ALS) — for the first-in-human trial of its investigational brain-computer interface, designed to enable individuals with paralysis to control external devices with their thoughts. The U.S. Food and Drug Administration initially cleared the study in May under…
Trial of brain-computer interface device for ALS now enrolling
NeuroSense Therapeutics has received key patents in Europe, Japan, and Israel covering the use of PrimeC, its investigational, fixed-dose combination therapy, in treating neurological diseases such as amyotrophic lateral sclerosis (ALS). These patents are valid through 2038 and join others covering Prime C’s use in the…
In a nearly unanimous vote, an advisory committee to the U.S. Food and Drug Administration (FDA) said there’s not enough evidence to support the efficacy of the experimental stem cell therapy NurOwn as a treatment for amyotrophic lateral sclerosis (ALS). The committee voted on a single question in its meeting: “Do…
I’ve lived in the shadow of my husband Todd’s ALS for the past 13 years. My days have been clouded by the bitter reality of knowing that life will only get harder until it’s over. The daily stresses of my caregiving are intense: clearing his airway when he…
Up to about 2.5 years of treatment with CNM-Au8 in an open-label extension of the HEALEY ALS platform trial significantly reduced the risk of death for individuals with amyotrophic lateral sclerosis (ALS) relative to a historical placebo group of patients from previous ALS clinical trials, according to new…
The U.S. Food and Drug Administration (FDA) has shared its major concerns with data available for NurOwn, BrainStorm Cell Therapeutics‘ experimental stem cell therapy for amyotrophic lateral sclerosis (ALS). According to a new briefing document put out by the FDA, the agency believes that currently…
There was a time when I could twist off the lid of a new jar of peanut butter with ease; I always enjoyed hearing that distinctive pop when the lids finally gave way. Pickles, spaghetti sauce, whatever: Those jars were no match for my grip strength and determination. Now, although…
A new Canadian initiative seeks to advance development of an artificial intelligence (AI) program aimed at helping healthcare professionals detect possible signs of amyotrophic lateral sclerosis (ALS) in the disease’s early stages. The AI program is crafted to analyze de-identified electronic medical records (EMRs) and detect individuals who should…
A first healthy volunteer has been dosed in a Phase 1 clinical study evaluating how safe and well tolerated is CVN293, a treatment candidate for amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease, the therapy’s developer, Cerevance, announced. The treatment, given orally, is designed to block a protein…
The European Medicines Agency (EMA) is now expected to issue a decision in the first months of 2024 on the conditional approval of masitinib as an add-on oral therapy for amyotrophic lateral sclerosis (ALS). The deadline extension follows a request, seeking more time, from AB Science, the therapy’s developer,…
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