Government
During a Sunday campaign event in Florida, President Donald Trump appeared to hint to the crowd that following the Nov. 3 election, he would terminate the decades-long tenure of Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
The U.S. – and global – response to the COVID-19 pandemic has been volatile at best. This is fair, considering that SARS-CoV-2 is a novel virus with a lethality we haven’t seen in more than a century.
Excess mortality rates in the U.S. remain high, despite a steady decline since mid-December.
EYSUVIS is the first FDA-approved ocular corticosteroid for the treatment of dry eye disease. Know more about how it got approval and the complete development timeline here.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 27, 2020.
While pre-license inspections of manufacturing sites are typically done following the acceptance of a BLA filing, due to the public health emergency of COVID-19, the FDA is instead requiring a quality control unit to be established by each manufacturer with detailed report submissions about their manufacturing processes.
“We are actively working with the FDA to find a way to expedite the plant inspection,” said Joe Turgeon, president and CEO of Spectrum Pharmaceuticals. “The manufacturing facility is ready for inspection and we are eager to assist the FDA in completing their assessment as soon as possible.”
After discovering promising indicators on the path to the development of Branaplam (LMIO70) for spinal muscular atrophy, Novartis now hopes to repurpose the drug for the treatment of Hungtington’s disease.
In the meeting, both the FDA and the U.S. Centers for Disease Control and Prevention presented details about COVID-19 and the requirements for a vaccine.
After reviewing its mid-pandemic performance, it became clear that its greatest challenge is around the handling of data, according to Amy P. Abernethy, M.D., Ph.D., principal deputy commissioner, FDA, speaking at the recent Demy-Colton Virtual Salon, the “Fusion of Technologies.”
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