Clinical research
The U.S. Food and Drug Administration said that data from BrainStorm Cell Therapeutics’ ALS Phase III trial does not meet the threshold of substantial evidence needed to support a BLA for the company’s ALS NurOwn therapy.
The retooled COVID-19 vaccine promised by GlaxoSmithKline and vaccine giant Sanofi is entering Phase IIb testing, with new antigen dosages it hopes will boost the lackluster immune response seen in adults 50 and over during its last Phase I/II trial.
Otonomy shares plunged 50.1% at news that its drug to treat Meniere’s disease failed to hit the primary endpoint in its Phase III trial.
Moderate to severe vasomotor symptoms (VMS), also known as hot flashes, have long been a problem by people facing menopause.
It was a busy week for clinical trial announcements. Here’s a look.
Tapinarof’s potential remittive effects could hold even more value for long-term psoriasis suffers. For patients coming into the trial with a PGA score of 0 (n=78), median time to the disease worsening (defined as a PGA score of ≥2) after discontinuing treatment was approximately 115 days, or 4 months.
In Phase III studies, Eli Lilly’s tirzepatide led to significant A1C and body weight reductions from baseline in adults with type 2 diabetes.
According to a statement made by Cortexyme, the partial hold was placed on the development program for atuzaginstat after an FDA review of the trial data identified hepatic adverse events.
Bluebird bio announced that it has placed its Phase I/II and Phase III trial of LentiGlobin gene therapy for sickle cell disease (SCD) on temporary suspension.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 16, 2021.
PRESS RELEASES