Biogen Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for tofersen, an investigational drug for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS).
The HEALEY ALS Platform Trial led by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital in collaboration with the Northeast ALS Consortium (NEALS) is a trial in which multiple investigational products are tested and evaluated simultaneously to accelerate the development of potential new therapies for people with ALS.
Albrioza (formerly AMX0035) was approved by Health Canada for ALS this week. NEALS sites and members were leaders of the CENTAUR trial of Albrioza.
12-month data show that earlier initiation of tofersen slowed decline across measures of clinical and respiratory function, strength, and quality of life
New PDUFA goal date scheduled for September 29, 2022 to allow time to review additional data
Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the U.S. Food and Drug Administration (FDA) has approved RADICAVA ORS® (edaravone), the oral form of edaravone, for the treatment of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease that currently has no cure and can progress rapidly.
Coya Therapeutics, Inc. (“Coya), a privately held clinical-stage biotechnology company developing first-in-class approaches utilizing autologous regulatory T cells (Treg) and Treg-derived exosome therapeutics for neurodegenerative and autoimmune diseases, today announced the publication of results from a Phase 1 trial entitled “Tregs Attenuate Peripheral Oxidative Stress and Acute Phase Proteins in ALS.”
The HEALEY ALS Platform trial led by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital in collaboration with NEALS has successfully enrolled its first participants for the investigational product SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion).
The Neurological Clinical Research Institute at Massachusetts General Hospital is seeking individuals to participate in a Longitudinal Assessment of the Gut Microbiome in People with ALS research study currently enrolling under the direction of Dr. James Berry.
The Emory ALS Center is looking for adults who are 18 years and older who are at risk for getting diagnosed with C9 ALS in the future.
