Regulatory
More than a dozen countries have suspended deployment of the AstraZeneca-Oxford University vaccine after cases of blood clots were reported.
Algernon Pharmaceuticals has requested a pre-Investigational New Drug meeting with regulators in the hopes of launching a clinical trial in stroke patients for n,n-dimethyltryptamine, a naturally derived psychedelic compound.
The goal is to “identify concrete and actionable steps to review and update the analysis of pharmaceutical mergers.”
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 16, 2021.
The drug is a lipoglycopeptide antibiotic. It is given in a single, one-hour infusion.
With more European countries pausing dosing of AstraZeneca’s COVID-19 vaccine over concerns about potential blood clotting side effects, Russia is seeking to fill in the gaps with its Sputnik V vaccine.
Sanofi and Regeneron Pharmaceuticals’ checkpoint inhibitor Libtayo performed so well that the regulators anticipate that the trials may need to be halt early.
The second half of March is a busy month for the U.S. Food and Drug Administration (FDA), with quite a few PDUFA dates scheduled. Here’s a look at this week’s target action dates.
With no permanent commissioner, the U.S. Food and Drug Administration appears to be both cracking down on Accelerated Approvals while struggling with a backlog of inspections.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 9, 2021.
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