Phase III
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 2, 2021.
Novavax Chief Executive Officer Stanley Erck believes the U.S. Food and Drug Administration could grant Emergency Use Authorization for its COVID-19 vaccine by May.
After announcing a successful primary endpoint in November, AstraZeneca and Amgen presented the full data on their severe asthma antibody candidate on Friday.
On Thursday, the company said the U.S. Food and Drug Administration wants to see additional data beyond the Phase III study announced last year.
It was another busy week for clinical trial news. Here’s a look.
The hold comes just after patient dosing began in HGB-210, the company’s Phase III single-arm open-label LentiGlobin trial for SCD patients between the ages of 2 and 50.
The date set by the FDA’s independent advisors for debating that decision is Friday, February 26.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 23, 2021.
Otezla, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) directed for cyclic adenosine monophosphate (cAMP), may indirectly modulate inflammatory mediators in certain conditions, but the specific underlying mechanisms are not clearly understood.
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.
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