Biopharma Update on the Novel Coronavirus: September 21

CV Update_September 21

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


FDA Actions

Reissued EUA: The FDA reissued a EUA for the Abbott ID Now COVID-19 test. It is intended to indicate testing for individuals who are suspected to have COVID-19 within first seven days of onset of symptoms, testing is authorized for laboratories certified under CLIA, testing facilities are required to report all results, revised labeling to update specimen transport and storage recommendations, revised health care provider and patient fact sheet and more.

Diagnostics Update: To-date the FDA has authorized 248 individual EUAs, which include 198 molecular tests, 46 antibody tests and 4 antigen tests.



Hoth Therapeutics announced it has entered into a Sponsored Research Agreement with George Washington University for the development of an in vitro diagnostic device. This device has the potential for health care professionals to test patients to immediately detect SARS-CoV-2 via a mobile device.

Data from revenue cycle management and lab informatics firm Xifin showed that serology testing volumes for COVID-19 peaked in May and then started to drop. As of September 13, 2020, serology SARS-CoV-2 testing made up less than 3% of all lab volume, compared to around 40% for molecular SARS-CoV-2 testing. In July, Xinfin noted that “antibody testing volumes have been significantly lower than anticipated.”


Testing Therapies, Antivirals and Vaccines

Petrovax, a Russian pharmaceutical company launched phase III clinical trials of CanSino Biologics’ COVID-19 vaccine candidate, Ad5,nCoV.

As reported by Seeking Alpha, Moderna and Pfizer have set different efficacy bars for their COVID-19 clinical trials. Modern and Pfizer both published their protocols for the trials of their respective candidates.

A new study, led by researchers at the NYU Grossman School of Medicine, found that an experimental compound prevents the virus that causes COVID-19 form entering human airway cells.


Company Actions/Announcements 

ARCA biopharma submitted an Investigational New Drug Application to the FDA under the Coronavirus Treatment Acceleration Program to evaluate AB201 for the treatment of patients hospitalized with COVID-19. ARCA intends to launch a Phase IIb/III study this year if approved.


Other Industry News

Pharmaceutical companies developing vaccines against the novel coronavirus pledged to put the integrity of the scientific process ahead of politics, but now, a political move by the Secretary of Health and Human Services has muddied the waters surrounding regulatory decisions. Please read more here

On CBS’s “Face the Nation”, Dr. Scott Gottlief, the former FDA commissioner said there is an unmistakable spike in new COVID-19 infections. And this is concerning heading into fall and winter.

Last Friday, the CDC updated their guidance acknowledging that COVID-19 can spread “through respiratory droplets or small particles, such as those in aerosols.” “Airborne viruses, including COVID-19, are among the most contagious and easily spread.” - Update, the CDC has reverted to its previous guidance, removing references to airborne transmission, as reported by CNN

Sharon Nachman, chief of the Division of Pediatric Infectious Diseases at Stony Brook Children’s Hospital, and co-authors, published a paper in Clinical Infectious Diseases titled “Warp Speed for COVID-19 Vaccines: Why are Children Stuck in Neutral?” They emphasize the need that it is time that clinical trials for COVID-19 vaccines include children.

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