Dosing has begun in a Phase 2/3 trial of SLS-005, Seelos Therapeutics’ infusion therapy to slow progression in amyotrophic lateral sclerosis (ALS) that is running as the fifth arm of the multi-regimen HEALEY ALS platform trial. The trial (NCT05136885) plans to…
A company called ProJenX has been launched and will focus on the clinical development of treatments for brain diseases, starting with prosetin, its lead candidate therapy for amyotrophic lateral sclerosis (ALS). ProJenX was created in collaboration with Project ALS, researchers at Columbia University, and Medical Excellence Capital, which…
The European Medicines Agency (EMA) has agreed to review a marketing authorization application (MAA) from Amylyx Pharmaceuticals requesting the approval of AMX0035 — a combination of two compounds — for the treatment of people with amyotrophic lateral sclerosis (ALS). The validation comes nearly two months after Amylyx filed the…
A research team in Canada received a CA$1.6 million (almost $1.25 million) grant from the Weston Family Foundation to study the benefits of a specific probiotic in people with amyotrophic lateral sclerosis (ALS). Probiotics — found in yogurt, fermented foods, and dietary supplements — are live microorganisms thought to improve…
Health Canada has authorized a new drug submission for masitinib — AB Science’s add-on therapy for amyotrophic lateral sclerosis (ALS) — under the notice of compliance with conditions policy (NOC/c), designed to get new medications to patients more quickly. If granted, this would allow conditional marketing of…
In response to the National Institute of Neurological Disorders and Stroke‘s (NINDS) request for community input regarding what it should prioritize to accelerate amyotrophic lateral sclerosis (ALS) research, the ALS Association’s overarching message is this: move swiftly to help patients. NINDS, which is part of the National…
It’s been nearly a year since the EveryLife Foundation for Rare Diseases released its expansive report finding the total economic burden of rare disorders in the U.S. to be nearly $1 trillion.
A U.S. Food and Drug Administration (FDA) advisory committee has scheduled a virtual meeting with Amylyx Pharmaceuticals to review its application for the approval of AMX0035 to treat amyotrophic lateral sclerosis (ALS), the company announced. The online meeting to discuss data supporting the approval request is set for March 30.
The investigational antibody therapy for amyotrophic lateral sclerosis (ALS), AT-1501, will now be called tegoprubart, its maker, Eledon Pharmaceuticals, has announced. The change comes after the United States Adopted Names (USAN) Council selected tegoprubart as the unique generic, or nonproprietary, name for the therapy candidate. The company…
The ALS Canada Research Program and the Brain Canada Foundation partnered to award CA$1.125 million (about $885,600) in grants to advance the understanding, diagnosis, and treatment of amyotrophic lateral sclerosis (ALS). The nine multidisciplinary research grants, awarded late last year to teams across Canada, seek to promote global…
