News

Tofersen to Treat SOD1 ALS Under Review for European Union

The European Medicines Agency (EMA) has agreed to review an application seeking the approval of tofersen in treating amyotrophic lateral sclerosis (ALS) caused by mutations in the SOD1 gene, the therapy’s developer, Biogen, reported. “Today’s announcement is an important milestone for the ALS community in Europe where there is a tremendous need…

Brain Implant May Someday Help ALS Patients Communicate

Researchers have developed a brain-machine interface (BMI) that could someday facilitate communication for people who have lost their ability to speak, including those with amyotrophic lateral sclerosis (ALS). After being trained to recognize certain patterns of nerve cell activity, the BMI could accurately predict the words a person with…

Veterans Call for FDA Committee Meeting on NurOwn’s Benefits

Veterans with amyotrophic lateral sclerosis (ALS) are calling for the U.S. Food and Drug Administration (FDA) to hold a public advisory committee meeting to discuss the benefits of NurOwn — an investigational cell-based therapy that military service members say has slowed their disease. The request follows the regulatory…

Results of Phase 3 Trial of TUDCA in Slowing ALS Likely Next Year

An ongoing Phase 3 clinical trial in Europe is testing whether tauroursodeoxycholic acid, added to standard therapy, can slow disease progression and extend survival among people with amyotrophic lateral sclerosis (ALS). The oral compound, also known as TUDCA, is one of the two ingredients in Relyvrio (sodium phenylbutyrate…