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. Department of Justice is set to recover more than $3 billion this year from pharmaceutical and medical device manufacturers as well as healthcare providers, labs and pharmacies found guilty of healthcare fraud under the False Claims Act.
The FDA is on a roll granting approvals. Three companies announced IND updates today.
A special fund for vaccine research that was set aside by the U.S. Department of Health and Human Services in 2010 has been misused to pay for unrelated expenses, a government report shows.
Senior White House adviser Andy Slavitt said the administration is striving to meet its goal of ensuring enough vaccine supply by summer, but acknowledged there could be some hurdles that will prevent that timeline.
Police have sealed off the area, according to the report. Few details were available, but eye witnesses said a robot was investigating a suspicious package found at the plant.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 26, 2021.
Pfizer, Moderna, AstraZeneca, and Johnson & Johnson all have trials of their respective vaccines underway in various age-groups.
AstraZeneca spinout Albireo Pharma is moving closer to securing regulatory approval for its treatment known as odevixibat, for pruritus in patients with PFIC.
One year and more than 410,000 deaths later, the United States is still firmly in the grips of the COVID-19 pandemic.
The drug, a combination of cabotegravir and rilpivirine, is a complete therapy for HIV-1 infection in adults who are virologically suppressed.