News

ALS Success Story Delivers Man’s ‘Most Special Day’

The Lifestyle Healing Institute (LHI), which uses a complementary and alternative medicine approach to care, is touting the success of an amyotrophic lateral sclerosis (ALS) patient whose mobility and quality of life are said to have improved following treatment. The case of Tod, a 60-year-old patient, demonstrates that…

FDA Declines to Consider Approving NurOwn to Treat ALS

The U.S. Food and Drug Administration (FDA) notified Brainstorm Cell Therapeutics that it will not accept for review a company application asking that its cell-based therapy NurOwn be approved as a treatment for amyotrophic lateral sclerosis (ALS). The FDA decision, in the form of a refusal to file…

Radicava Oral Suspension Approved in Canada to Treat ALS

Radicava Oral Suspension, an oral formulation of edaravone, has been approved in Canada for treating amyotrophic lateral sclerosis (ALS). Mitsubishi Tanabe Pharma Canada (MTP-CA), the subsidiary of Mitsubishi Tanabe Pharma America that markets Radicava in Canada, has announced plans to make the oral formula available to patients…

NurOwn Continues to Show Benefit in Rapidly Advancing ALS

The investigational cell-based therapy NurOwn may slow disease progression in people with amyotrophic lateral sclerosis (ALS) who have less severe disease, according to analyses from a Phase 3 trial. Researchers’ analyses excluded patients with the lowest scores on the ALS Functional Rating Scale–Revised (ALSFRS-R) or in individual…

Biomarkers May Determine ALS Progression, Edaravone Response

Continuous monitoring of certain biomarkers in people with amyotrophic lateral sclerosis (ALS) may inform about the risk of disease progression and the response to edaravone, according to interim data from the ongoing REFINE-ALS biomarker study. Mitsubishi Tanabe Pharma America (MTPA), the developer of edaravone, recently shared these findings…

Stealth Biotherapeutics’ SBT-272 Earns Orphan Drug Status

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Stealth Biotherapeutics’ investigational therapy SBT-272 for the treatment of amyotrophic lateral sclerosis (ALS). Aimed at speeding the development of new treatments for rare, life-threatening diseases, orphan drug status offers regulatory support and certain financial incentives…

New Study Uncovers Mechanism of CuATSM, ALS Therapy Now in Trials

CuATSM, a potential amyotrophic lateral sclerosis (ALS) therapy that’s now in clinical trials, may work by altering how certain cells in the brain generate energy, a new study suggests. Researchers say these findings may help to identify patients most likely to respond to the experimental treatment. “Screening patient derived…