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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As the spread of the Omicron variant of COVID-19 picks up speed, vaccine makers are rushing to test their shots against the new mutation, with mixed results.
Biogen and Eisai reported that the Committee for Medicinal Products for Human Use of the European Medicines Agency had decided not to recommend the drug for its MAA.
With the holidays around the corner and people expected to gather, public health officials have expressed concerns over a possible increase in COVID-19 cases, particularly with the highly infectious Omicron variant on the rise.
U.S. District Judge Colleen McMahon rejected a bankruptcy plan that shielded the Sackler family from potential lawsuits related to the opioid crisis.
In a unanimous vote made by U.S. health officials, the advisers decided the safer Pfizer and Moderna vaccines should be given as boosters.
BeiGene and other China-based pharma companies have been nervously watching the Biden administration and its response to some companies in that region that have allegedly been involved with the Chinese military’s weapons programs and human rights violations.
A recent study estimates that in the U.S. alone the vaccines saved 1.1 million lives and prevented 10.3 million hospitalizations. For that and more COVID-19 news, continue reading.
As the Omicron variant of the SARS-CoV-2 virus sweeps much of the globe, scientists are digging into why this particular mutation is spreading even more rapidly than its predecessors.
Shares of BeiGene have fallen 16% in China in part due to concerns over potential U.S. sanctions against Chinese biotech companies.
Texas’ top law enforcement official is taking aim at two drug companies over what he alleges is the promotion of hormone blockers for children experiencing gender dysphoria.