Infectious disease
Excess mortality rates in the U.S. remain high, despite a steady decline since mid-December.
Eli Lilly is continuing their other trial in mild-to-moderate COVID-19 patients and stated they “remain confident … that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19.”
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.
Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located. Aridis Chief Executive Officer Vu Truong believes his company has a better solution – an inhaled antibody.
Days after the U.S. FDA greenlit the restart of AstraZeneca’s Phase III COVID-19 vaccine trial, the company said the preventative medication boosts immune responses in older and younger adults against the novel coronavirus.
The pharmaceutical supply chain is being pushed to its limit as it prepares to deliver COVID-19 vaccines and therapeutics to the entire world as soon as possible, while continuing to produce and deliver all the usual medications and products.
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.
Shares of Gilead Sciences are jumping in aftermarket trading following full approval for Veklury (remdesivir) as a treatment for COVID-19. The approval marks the first drug approved by the U.S. Food and Drug Administration as a treatment for the novel coronavirus.
Moderna has fully enrolled its late-stage coronavirus disease 2019 (COVID-19) vaccine trial by hitting its target of 30,000 participants. More than one-third of this cohort includes minority participants.
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