BrainStorm Cell Therapeutics is withdrawing the application requesting U.S. approval of its cell-based therapy NurOwn for the treatment of amyotrophic lateral sclerosis (ALS). The decision comes on the heels of a recent U.S. Food and Drug Administration (FDA) advisory committee meeting, in which experts ruled nearly unanimously…

An advisory committee of the European Medicines Agency has maintained its recommendation not to approve AMX0035 for amyotrophic lateral sclerosis (ALS). In its initial assessment issued in June, the Committee for Medicinal Products for Human Use (CHMP) said data from the CENTAUR Phase 2 trial (NCT03127514), which formed…

One of our greatest sources of joy and normalcy when my late husband, Jeff, was living with ALS was getting out and about in the community. The more ALS seemed intent on changing our life, the more determined Jeff became to find ways around it. I was his…

When ALS first caused my husband, Todd, to need a wheelchair, he realized he couldn’t recline too far in it or he’d get stuck there; his arms were too weak to reach the joystick or seat-control buttons. To compensate, his durable medical equipment technician added an egg switch to…

Spinogenix has won a nearly $1 million grant from the U.S. Department of Defense (DoD) to move ahead with clinical testing of SPG302, a small molecule candidate for amyotrophic lateral sclerosis (ALS). This is DoD’s Congressionally Directed Medical Research Programs’ second grant to the company, following a…

Direct measures of muscle strength were correlated with functional abilities among amyotrophic lateral sclerosis (ALS) patients in a Phase 2 clinical trial. Measures of arm and hand muscle strength aligned well with functional domains related to fine motor skills (e.g., handwriting, grasping), whereas leg and foot strength were related…

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…

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…

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…

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…