Lindsey Shapiro, PhD, science writer —

Mitsubishi Tanabe Pharma Corporation (MTPC) is seeking approval to manufacture and market MT-1186, an oral formulation of edaravone, in Japan for amyotrophic lateral sclerosis (ALS). A similar application recently gained priority review in the U.S., which reduced regulatory review time from the standard 10 months to six months. A…

University of Sydney neurologist Matthew Kiernan, PhD, has been granted the 2022 Sheila Essey Award for his groundbreaking research, aimed at providing earlier diagnoses and better treatments for people with amyotrophic lateral sclerosis (ALS). Kiernan, a world-leading expert in the field of ALS research, is the first Australian to…

Note: This story was updated April 4, 2022, to clarify that 700 participants, including both ALS patients and healthy volunteers, have been recruited to the study. Mitsubishi Tanabe Pharma America (MTHA) has joined EverythingALS’s consortium to accelerate the development of new digital biomarkers for amyotrophic lateral…

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…

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…

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.

NP001 slowed functional and lung declines in a subset of middle-aged patients with amyotrophic lateral sclerosis (ALS) who had high levels of inflammation, according to an analysis of previous data from Phase 2a and 2b clinical trials. While earlier results failed to show overall…

Urine levels of neopterin, a marker of inflammation, are linked to disease progression in people with amyotrophic lateral sclerosis (ALS), a study revealed. That means, according to researchers, that neopterin could be used as a biomarker to monitor disease status and determine whether certain treatments will be effective. The…

The U.S. Food and Drug Administration (FDA) has approved a Phase 2 clinical trial of the psychedelic ketamine, PharmaTher’s experimental treatment for amyotrophic lateral sclerosis (ALS). FDA approval was requested through an investigational new drug application (IND) submitted by the study’s principal investigator, Richard Barohn, MD, a neurologist…