FDA advisory committee votes against NurOwn approval for ALS

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,…

“Find your own Calcutta. Find the sick, the suffering, and the lonely, right where you are — in your own homes and in your own families, in your workplaces and in your schools. You can find Calcutta all over the world, if you have eyes to see.” — Mother…

Disaster preparedness, including stockpiling goods, owning and knowing how to use emergency equipment, and being aware of community resources, is lacking among amyotrophic lateral sclerosis (ALS) patients and caregivers, a recent Japanese study suggests. While patients who needed a ventilator were generally found to be better prepared during power…