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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In its CRL, the FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications.
Russia’s minister of health, Mikhail Murashko, indicated that the country plans a nationwide program to vaccinate its population against COVID-19 starting in October.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 3, 2020.
August is a busy month on the U.S. Food and Drug Administration (FDA)’s calendar. Here’s a look at this week’s schedule.
The U.S. Department of Defense granted Monmouth Junction, New Jersey-based CytoSorbents Corporation a $4,421,487 three-year contract to complete preclinical development of its HemoDefend-BGA plasma and whole blood adsorber.
GlaxoSmithKline and Sanofi struck a $2.1 billion deal with the U.S. government’s Operation Warp Speed program to supply an initial 100 million doses of a COVID-19 vaccine candidate under development by the two companies.
The U.S. FDA issued a new template for clinical test developers that is designed to assist these companies in developing and submitting emergency use authorization (EUA) for COVID-19 tests that can be performed at home or in other settings besides laboratories.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 31, 2020.
Three months after joining forces to develop an adjuvanted vaccine for COVID-19, Sanofi and GlaxoSmithKline reached an agreement with the U.K. government to provide up to 60 million doses of the preventative medication.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 29, 2020.