Regulatory
The results published in the NEJM state that pegcetacoplan met the study’s primary endpoint for efficacy, demonstrating an advantage over eculizumab with a statistically significant improvement in adjusted means of 3.8 g/dL of hemoglobin at week 16 (p<0.001). An impressive 85% of patients were transfusion free at 16 weeks, in contrast to only 15% of eculizumab-treated patients.
According to an interview with Soumya Swaminathan, the WHO’s chief scientist, the new investigational COVID-19 vaccines rely on alternative technologies and systems of delivery. Some include oral and nasal administration, while others use skin patches.
The HHS will limit the use of Bamlanivimab antibody treatments developed by Regeneron and Eli Lilly due to concerns the medications are not effective against these new strains.
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.
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