Regulatory
A briefing document from the U.S. FDA cites critical safety concerns with Pfizer and Eli Lilly’s anti-NGF osteoarthritis drug tanezumab, despite the fact that clinical trials have demonstrated the agent can help patients with osteoarthritis.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 23, 2021.
Although the beginning of March was fairly slow, the end of the month shows a busy schedule for PDUFA dates for the U.S. FDA. Read on to see what’s on the calendar for this week.
The approval was for Arcalyst (rilonacept), a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling.
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.”
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