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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Less than one week after forging a vaccine manufacturing agreement with Novavax, FUJIFILM Diosynth Biotechnologies announced its College Station, Texas facility was selected by the federal government to support COVID-19 vaccine candidate manufacturing.
The U.S. House of Representatives approved a $3.2 billion budget proposal for the U.S. Food and Drug Administration (FDA) that will boost the agency’s abilities to approve new medicines and medical devices, as well as protect the nation’s food supplies.
The IGNITE DMD study is assessing the company’s microdystrophin gene therapy asset SGT-001 as a potential treatment for DMD.
Stéphane Bancel, Moderna’s chief executive officer, stated, “We thank BARDA for this continued commitment to mRNA-1273, our vaccine candidate against COVID-19.”
On Friday, President Donald Trump signed four executive orders in hopes of lowering prescription drug prices in the United States, which was a 2016 campaign promise.
The U.S. Food and Drug Administration (FDA) approved Kite Pharma’s Tecartus (brexucabtagene autoleucel) for adults with relapsed or refractory mantle cell lymphoma (MCL). Kite is a Gilead Science company.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 27, 2020.
The Prescription Drug User Fee Act (PDUFA) was first passed into law by the U.S. Congress in 1992.
A U.S. Patent and Trademark Office administrative court rejected Moderna’s arguments that Arbutus’s ‘069 patent should be revoked because it “described obvious concepts.”
This morning, AstraZeneca announced the approval of the triple-therapy Breztri Aerosphere as a maintenance treatment for COPD.