Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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The U.S. Senate confirmed Xavier Becerra as Secretary of the Department of Health and Human Services in a 50-49 vote.
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.”
The U.S. Attorney’s Office for Massachusetts charged Ishtiaq Ali Saaem, 37, with obstruction of justice for lying about his attempts to acquire 100 castor bean packets in order to develop the bioterror poison ricin. The acquisition was not recent, it took place on June 24, 2015.
France and Germany are two out of more than a dozen countries that suspended deployment of the AstraZeneca-Oxford University vaccine after reports of blood clots were reported.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 16, 2021.