A Phase III trial of NurOwn (MSC-NTF cells), BrainStorm Cell Therapeutics’ investigational therapy for amyotrophic lateral sclerosis, did not find a statistically significant difference between the product and placebo for improving scores on a revised ALS functional rating scale (ALSFRS-R) that measures the severity of the disease.
The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) for Sanofi’s blood cancer treatment sutimlimab.
Merck and Eisai announced new investigational data demonstrating positive top-line results from the Phase III KEYNOTE-581/CLEAR trial (Study 307).
Shares of Calliditas Therapeutics soared in trading after the company announced positive Phase III data from a study of Nefecon in IgA nephropatjhy (IgAN), an autoimmune renal disease.
Cytokinetics’ stocks plummeted after the company released topline results from a Phase III cardiovascular clinical trial with partners Amgen and Servier in which the secondary endpoint to prove potential to save lives failed.
Final Results of National Institute of Allergy and Infectious Diseases’ ACTT-1 Trial Published in New England Journal of Medicine Expand Clinical Benefits of Veklury® (remdesivir) for the Treatment of COVID-19 […]
A rheumatoid arthritis drug developed by Genentech proved to be effective in benefitting patients who have Covid-19-associated pneumonia, according to new late-stage clinical trial data.
The U.S. Food and Drug Administration accepted Copenhagen, Denmark-based Orphazyme’s New Drug Application (NDA) for arimoclomol for the treatment of Niemann-Pick disease Type C.
Shares of Satsuma Pharmaceuticals plunged in trading after the company revealed the migraine treatment STS101 failed to hit co-primary endpoints in a late-stage study.
Sanofi announced disappointing results from a Phase III study of intravenously dosed Kevzara (sarilumab) in which hospitalized Covid-19 patients failed to meet primary and secondary endpoints.
