Orphan Drug Status Recommended for Pridopidine in Europe

A branch of the European Medicines Agency (EMA) has recommended that Prilenia’s investigational therapy pridopidine be designated an orphan medicine to treat people with amyotrophic lateral sclerosis (ALS). Medicines with the potential to become safe and effective treatments for rare, life-threatening, or chronically debilitating conditions affecting no more than one…

SLS-005 Earns Orphan Drug Status in Europe

The European Medicines Agency (EMA) has granted orphan drug designation to Seelos Therapeutics‘ investigational therapy SLS-005 for the treatment of amyotrophic lateral sclerosis (ALS), the company announced in a press release. Orphan drug status in Europe is given to medicines with the potential to be safe and…

AB Science’s New Masitinib Study Validated by EMA, With Expected Start Later This Year, Company Says

AB Science has optimized the design of a Phase 3 confirmatory study for mastinib, its oral treatment for amyotrophic lateral sclerosis (ALS), to avoid any possibility of bias. The optimized protocol for the study (NCT03127267), not yet recruiting, was validated by the European Medicines Agency (EMA). Although AB…