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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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 22, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 21, 2020.
The U.S. Biomedical Advanced Research and Development Authority (BARDA) paid more than $1 billion to support the development, production and delivery of the vaccine beginning this fall.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 20, 2020.
Clovis Oncology’s Rubraca remained the only PARP inhibitor approved for prostate cancer for only a handful of days. Today, that medication is joined by AstraZeneca’s and Merck’s powerhouse PARP inhibitor, Lynparza.
As part of the agreement, Phlow will help build the United States’ first Strategic Active Pharmaceutical Ingredients Reserve, a long-term, national stockpile to secure key ingredients used to manufacture the most essential medicines in the United States.
Research conducted under the collaboration will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns through the use of relevant and new data sources.
Expected to launch in June or July, the study plans to test as many as 325,000 people to learn how the SARS-CoV-2 virus is spreading nationally, according to Reuters, reporting before the official announcement.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 19, 2020.
The approval was based on interim analysis from the company’s Phase III IMpower110 trial.