Biopharma Update on the Novel Coronavirus: May 29
News information is not all-inclusive. Please check back for updates.
EUA: The FDA issued a EUA for the Stryker Sustainability Solutions (SSS) VHP N95 Respiratory Decontamination System (RDS).
SARS-CoV-2 Reference Panel: The FDA provided a SARS-CoV-2 reference panel which is an independent performance validation step for diagnostic tests of COVID-19 that are being used for clinical purposes.
Diagnostics Update: The FDA has worked with more than 400 test developers who have submitted or plan to submit EUA requests to detect COVID-19. Also, 113 individual EUAs have been issued, which includes 100 molecular tests, 12 antibody tests and 1 antigen test.
Quest Diagnostics announced it has received EUA from the FDA for the Quest Diagnostics Self-collection Kit for COVID-19. The kit is an at-home, self-collect nasal specimen.
LetsGetChecked, a direct-to-consumer at-home health testing company, announced FDA authorization of the new Coronavirus (COVID-19) Sure-track Test for at-home consumer use.
LexaGene Holdings announced the Dartmouth-Hitchcock Medical Center is using its experimental rapid COVID-19 detection device in its laboratory. LexaGene is seeking Emergency Use Authorization for the device.
Testing Therapies, Antivirals and Vaccines
Partner Therapeutics, launched a clinical study of Leukine (sargramostim, rhu-GM-CSF) in patients with acute respiratory failure associated with COVID-19 in Singapore. The study will evaluate the effect of Leukine on lung function and other important patient outcomes. The Singapore study will be open to patients hospitalized for COVID-19 who are experiencing acute hypoxic respiratory failure. The primary endpoint evaluates Leukine's impact on lung homeostasis.
Kalytera Therapeutics announced new proof-of-concept data showing that R-107 reduces tissue damage and preserves organ function in a lethal rodent model of sepsis that mimics the circulatory shock seen with COVID-19 associated lung disease. R-107 is a liquid prodrug of nitric oxide that can be administered by injection.
Merck has partnered with a small startup Vaxxas to utilize Vaxxas’ proprietary High Density Microarray Patch (HD-MAP) platform for a vaccine candidate.
Other Industry News
Last week the CDC updated and clarified guidance on the transmission of coronavirus. The CDC states, “it may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes.”
As reported by The Hill, watchdog groups are pushing for Operation Warp Speed, the White House administration's initiative to find a COVID-19 vaccine, to disclose all ties to drug companies.
A new survey conducted by the Lupus Research Alliance showed that more than one-third of Lupus patients experienced significant issues filling their hydroxychloroquine (Plaquenil) prescription during the COVID-19 pandemic. Results showed that the time patients had trouble filling their prescriptions was in the months of March and April, which coincided with early data broadly reported in the media suggesting possible benefit for hydroxychloroquine to treat or prevent COVID-19.