Government

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 29, 2020.
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.
FDA
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.
FDA
This morning, AstraZeneca announced the approval of the triple-therapy Breztri Aerosphere as a maintenance treatment for COPD.
PRESS RELEASES