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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Charles Lieber, the former chair of Harvard University’s Chemical Biology Department, was indicted by a federal grand jury this week on two counts of making false statements.
Fauci, a longtime infectious disease expert, said COVID-19 is the stuff of nightmares in the way it has quickly spread across the globe, infected millions of people and contributed to the deaths of more than 408,000 people.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 8, 2020.
The next two weeks are busy ones for the U.S. Food and Drug Administration (FDA). Here’s a look at PDUFA dates for this period.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 5, 2020.
“We are genuinely honored at the opportunity to protect our military personnel and their families who have devoted themselves to the needs of U.S. citizens and others worldwide,” said Stanley C. Erck, president and chief executive officer of Novavax.
Inovio’s development issues for its vaccine candidate have become mired in a conflict with the contract manufacturing organization it has worked with on previous projects.
Instead of detecting the virus, this device can help determine who might be at risk for intubation and mechanical ventilation.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 4, 2020.
Less than one month after the White House zeroed in on 14 vaccine candidates for COVID-19, the administration has narrowed that list even more to five potential treatments for the prevention of the novel coronavirus.