Clinical research
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.
To facilitate its goal of building an industry-leading gene therapy company focused on rare CNS diseases, Sio has made it a priority to interact with patient organizations to determine their primary objective, whether that be stability or a cure.
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.
Bristol Myers Squibb and bluebird bio said data from the Phase II KarMMa study evaluating the safety and efficacy of ide-cel (idecabtagene vicleucel) met the primary endpoint of overall survival and the key secondary endpoint of complete response rate.
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.
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