Biopharma Update on the Novel Coronavirus: September 4

CV Update_September 4

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


FDA Actions

Warning Letter: The FDA and the FTC issued a warning letter to 1 Party At A Time for selling fraudulent COVID-19 products.

Investigational COVID-19 Convalescent Plasma: The FDA updated its guidance on convalescent plasma to provide additional information related to the EUA issued for use in the treatment of COVID-19.

Diagnostics Update: To-date the FDA has authorized 240 individual EUAs, which include 193 molecular tests, 43 antibody tests and 4 antigen tests.



Swiss-based Roche announced today that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for a diagnostic test to quickly identify whether a patient has COVID-19 or one or two flu viruses. 

ADMA Biologics, Inc. announced the launch of COVID-19 ImmunoRank Neutralization MICRO-ELISA, a proprietary, fully-validated ELISA assay for the detection of SARS-CoV-2 neutralizing antibodies in plasma. ImmunoRank is intended for use as an aid to identify individuals who produce an adaptive immune response to SARS-CoV2, indicating recent or prior infection, and specifically for the detection of circulating SARS-CoV2 neutralizing antibodies in human plasma of all immune globulin classes.


Testing Therapies, Antivirals and Vaccines

NanoViricides, based in Shelton, Connecticut, outlined its approach to developing therapies against COVID-19 at the LD 500 investor conference yesterday. Anil R. Diwan, company president and executive chairman, indicated that since January 2020, they have been working with very limited resources and boot-strapping on the company’s past work against coronaviruses, but is close to announcing a clinical candidate. Read more here

Months after forging a development partnership for a COVID-19 vaccine, GlaxoSmithKline and Sanofi are moving their adjuvanted vaccine candidate into the clinic. Read more here

Johnson & Johnson announced that Janssen’s lead COVID-19 vaccine candidate, Ad26.COV2.S, showed promising results in preclinical studies. The candidate prevented severe disease in Syrian golden hamsters and was published in Nature Medicine.

Mesoblast Limited reported the independent Data Safety Monitoring Board recommended continuation of the Phase III trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection, following completion of the trial’s first interim analysis. The analysis was performed on the first 30% of the total target of randomized patients, with the DSMB reviewing the trial’s primary endpoint, all-cause mortality within 30 days of randomization and all safety data.


Company Actions/Announcements 

When Moncef Slaoui was tapped to helm Operation Warp Speed, he sought confirmation that politics would not play a role in driving certain treatments through an approval process without the proper supporting scientific data to back it up. Now he indicates he will quit if it is driven by politics. Read more here


Other Industry News

Recently, the U.S. Centers for Disease Control and Prevention (CDC) made a regular data update on COVID-19 deaths. Unfortunately, the data, and how it was presented, was immediately misinterpreted and widely disseminated by conspiracy theorists to suggest that the actual deaths caused by COVID-19 were dramatically lower than previously reported. Please read more here

The U.S. Centers for Disease Control and Prevention (CDC) notified the public health departments in all 50 states and five large cities to prepare for the possibility of distribution of a COVID-19 vaccine by November 1. Please read more here. 

Researchers at San Francisco’s Gladstone Institutes published research on bioRxiv—which means it has not been peer-reviewed—that demonstrated, in culture, how the virus damages cardiac muscles. Please read more here

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