Tags : Amyotrophic Lateral Sclerosis

Clinical Trials

Alexion to Discontinue its P-III CHAMPION-ALS Trial of Ultomiris (ravulizumab)

Shots: The IDMC has recommended the discontinuation of the P-III CHAMPION-ALS trial for Ultomiris (IV, q8w) in adults with ALS. Additionally, enrolled patients will discontinue the study medication and complete any required follow-up assessment The discontinuation is due to lack of efficacy based on the pre-specified interim analysis. No new safety was identified while the […]Read More

Regulatory

Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat

Shots: EMA’s COMP has granted ODD to SLS-005 for the treatment of amyotrophic lateral sclerosis Under ODD, Seelos will get benefit from several incentives such as protocol assistance, reduced regulatory fees and market exclusivity Trehalose is a low molecular weight disaccharide (0.342 kDa) that crosses the BBB, stabilizes proteins and activates autophagy and has received […]Read More

Biotech

MTPA and Aquestive Sign a License and Supply Agreement for

Shots: Aquestive will receive upfront, milestones, royalties on net sales for Exservan (oral film formulation) in the US and will earn revenue pursuant to the exclusive supply agreement MTPA to commercialize Exservan in the US while Aquestive will serve as the exclusive sole manufacturer and supplier for the product Exservan is an oral film formulation […]Read More