Biopharma Update on the Novel Coronavirus: October 2

CV Update_October 2

News information is not all-inclusive and updates are published on Mondays, Wednesdays and Fridays. 


FDA Actions

The U.S. Food and Drug Administration (FDA) had a busy week, which included granting Emergency Use Authorization (EUA) to multiple diagnostic tests related to COVID-19. Read more about the EUAs in the 'Diagnostics' section below. 


LabCorp announced it received Emergency Use Authorization from the FDA for a new, high-throughput method that uses heat and technology to extract RNA from samples collected for COVID-19 molecular testing.

Beckman Coulter announced it received EUA for its Access Interleukin-6 (IL-6) assay from the FDA. Access IL-6 is a fully automated immunoassay designed to detect IL-6 levels in serum and plasma which can be used to aid physicians in identifying a severe inflammatory response and determining the risk of intubation with mechanical ventilation in COVID-19 patients.

Cepheid received EUA from the FDA for Xpert Xpress SARS-CoV-2/Flu/RSV, a rapid molecular diagnostic test for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient sample. The four-in-one test is designed for use on any of Cepheid's over 26,000 GeneXpert Systems placed worldwide, with results delivered in approximately 36 minutes.

Testing Therapies, Antivirals and Vaccines

Doctors in Massachusetts were able to use a type of laser therapy to successfully treat COVID-19 in a patient. The patient is part of a randomized clinical pilot trial involving 10 patients. Following treatment with the laser, Photobiomodulation Therapy, the patient showed a decrease in inflammatory markers, IL-6 and Ferritin, and marked improvement in radiological findings.


Company Actions/Announcements 

Cobra Biologics will manufacture Scancell Holdings’ COVID-19 DNA vaccine candidate that will target the SARS-CoV-2 nucleocapsid (N) protein plus the key receptor binding domain of the spike (S) protein to generate both T cell responses and virus-neutralizing antibodies against the SARS-CoV-2 virus. This new vaccine has the potential to provide long-lasting immunity against COVID-19 by generating protection not only against this strain, but also against new strains of coronavirus that may arise in the future.

Gilead Sciences, Inc. has ramped up production of Veklury (remdesivir) and, as a result, has been able to donate 1.5 million vials of the medication to health officials across the globe to treat COVID-19 patients. Starting Oct. 1, Gilead will be responsible for distributing Veklury in the United States upon the conclusion of the previous distribution agreement with the government. To ensure stable management of drug supply, AmerisourceBergen will continue to serve as the sole U.S. distributor of Veklury through the end of this year and will sell the product directly to hospitals.

Other Industry News

President Donald Trump, along with First Lady Melania Trump and White House adviser Hope Hicks, has tested positive for COVID-19. At 74 years old, Trump is in a category of older Americans who are at more vulnerable to infection, and at higher risk of developing more serious symptoms.

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