Avextra announces the approval of NEUROBIS by the Italian Medicines Agency: A Phase II clinical trial Avextra AG, a European manufacturer and developer of Cannabis-based medicines located in Germany, has announced that both the Italian Medicines Agency AIFA and the Italian Ministry of Health have granted formal approval for a multi-centre Phase II study to…
Category: Amyotrophic Lateral Sclerosis (ALS)
Pridopidine for ALS – promising results
At the 10th Congress of the European Academy of Neurology (EAN) 2024, Prilenia Therapeutics presented promising results from the additional analyses of Phase II Healey ALS Platform Trial evaluating pridopidine in ALS patients. The positive results will pave the way for the Phase III trial of pridopidine. Developing disease-modifying treatments for amyotrophic lateral sclerosis (ALS)…
Clinical trial for ALS patients
10 April 2024: Axoltis Pharma, a French biopharmaceutical company dedicated to developing therapeutic solutions for neurodegenerative diseases, today announced the authorisation from ANSM, the French agency for the safety of health products, to launch the SEALS study. This phase II clinical trial of drug candidate NX210c in patients with Amyotrophic Lateral Sclerosis (ALS) is the…
Emylif – orodispersible film for ALS
January 24, 2024: In November 2023, Zambon UK launched Emylif, a new formulation of riluzole in an orodispersible film – for the treatment of adults with amyotrophic lateral sclerosis (ALS). Emylif offers an alternative to the tablet administration of riluzole which can be difficult for patients to take as their disease progresses and they develop…
FDA approves QALSODY™ (tofersen) targeting a genetic cause of ALS
25 April 2023: Ionis Pharmaceuticals, Inc today announced that its partner Biogen has received U.S. Food and Drug Administration (FDA) approval of QALSODY™ (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval…
Study finds Pison AI technology can detect neurological disorder in ALS patients
Lewis Katz School of Medicine at Temple University research shows Pison’s Neural Biosensor can potentially enable remote monitoring, early detection and intervention for neurological diseases Pison have announced the results of recent clinical trial conducted by researchers at the Lewis Katz School of Medicine at Temple University’s MDA/ALS Center of Hope, in the US. The trials concluded…
Pridopidine for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for pridopidine for the treatment of ALS. Prilenia recently received a positive opinion from the Committee of Orphan Medicinal Products (COMP) in…
