Biopharma Update on the Novel Coronavirus: October 13

CV Update_October 13

News information is not all-inclusive and updates are published once a week on Tuesdays. 


FDA Actions

Coronavirus Treatment Acceleration Program: The FDA updated the dashboard on the CTAP webpage. As of the end of September, there are 550+ drug development programs in planning stages, 350+ trials reviewed and 5 COVID-19 treatments are currently authorized for emergency use.

New Webpage: Last week, the FDA launched to provide new information as it becomes available.

Warning Letters: The FDA issued warning letters to Griffo Botanicals and Prairie Dawn Herbs for selling fraudulent COVID-19 related products. The FDA also issued a warning letter to Battelle Memorial Institute for failure to comply with regulatory reporting requirements.

Diagnostics Update: To-date the FDA has authorized 278 individual EUAs, which include 217 molecular tests, 55 antibody tests and 6 antigen tests.



Roche announced it will launch a high-volume SARS-CoV-2 antigen test to help diagnose infections.

Thermo Fisher Scientific launched a new portfolio of SARS-CoV-2 antibody tests featuring the Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA test and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test. The OmniPATH COVID-19 Total Antibody ELISA test has been granted Emergency Use Authorization from the FDA. 

GenMark Diagnostics received regulatory approval for a single lab test that can detect COVID-19 along with 20 other common respiratory ailments.


Testing Therapies, Antivirals and Vaccines

Johnson & Johnson paused the clinical trial of its COVID-19 vaccine due to “an unexplained illness in a study participant.”

Moncef Slaoui, the head of Operation Warp Speed, the government project to push along the COVID-19 vaccine development, suggested the first Emergency Use Authorization (EUA) for a vaccine will likely be around Thanksgiving.

Several researchers raised concerns over Russian vaccine data. Please read more here

The U.S. National Institutes of Health (NIH) is launching a clinical trial of a combination of Gilead Sciences’ antiviral drug remdesivir (Vitrakvy) and hyperimmune intravenous immunoglobulin (hIVIG).

A new, nanoparticle tool mimics the way the SARS-CoV-2 virus infects a cell, letting scientists perform vital COVID-19 research without the risk of becoming infected themselves. Consequently, any lab – not just those with viral containment facilities – can study this deadly virus safely. Please read more here

Mesoblast Limited announced the randomized controlled Phase III trial of remestemcel-L on top of maximal care in ventilator-dependent patients with acute respiratory distress syndrome (ARDS) due to COVID-19 infection has surpassed 50% enrolment. The trial’s primary endpoint is a reduction in 30-day mortality relative to maximal care. ARDS continues to be the primary cause of death in COVID-19 patients.

Caladrius Biosciences opened its proof-of-concept study of CLBS119 as a treatment for COVID-19-induced lung damage and begun screening prospective patients for inclusion at NYU Langone Health. This planned 12-patient open-label clinical trial will evaluate the safety and efficacy of a single administration of CLBS119 (peripheral blood-derived autologous CD34+ cells) for the treatment and repair of COVID-19-induced lung damage in adults. The study will target patients who are experiencing hypoxia due to prior infection with SARS-CoV-2 and who require supplemental oxygen.


Company Actions/Announcements 

AstraZeneca signed a deal with Operation Warp Speed, the U.S. government program to advance COVID-19 vaccines and therapeutics, for a monoclonal antibody cocktail. This is the same class of therapeutics as Regeneron Pharmaceuticals’ and Eli Lilly’s antibody treatments. 

Supplies of remdesivir are running out across Europe, leading to rationing and reliance on the generic drug, dexamethasone. The UK rationed its supplies of remdesivir last Tuesday in the face of rising demands. Poland is in short supply and hospitals in the Netherlands report the drug is out of stock in that country. Please read more here

Regeneron Pharmaceuticals indicated it has applied to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for its antibody cocktail against COVID-19. 

Last week the White House reversed its position on new vaccine guidelines proposed by the U.S. Food and Drug Administration.

Eli Lilly is seeking Emergency Use Authorization (EUA) for its antibody therapy, LY-CoV555, for the treatment of high-risk patients with recently diagnosed mild-to-moderate coronavirus disease 2019 (COVID-19).


Other Industry News

What we know now about COVID-19 transmission, where the virus goes in your body and how it spreads. Please read more here

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones, including COVID-19 pain relief. 

As COVID-19 cases continue to rise in the United States, the editors of the prestigious New England Journal of Medicine have taken an unprecedented political stance and called for a change in political leadership this country.

Rick Bright was the head of the Biomedical Advanced Research and Development Authority (BARDA), who was reassigned in April after raising concerns about the Trump administration’s COVID-19 response and nepotism in the Department of Health and Human Services (HHS). Bright resigned from the federal government last week. 

Altimmune, Inc.. pre-published a comprehensive preclinical evaluation of its single-dose, intranasal COVID-19 vaccine candidate, AdCOVID, in a manuscript entitled, “Single-dose intranasal administration of AdCOVID elicits systemic and mucosal immunity against SARS-CoV-2 in mice.” The studies were conducted as part of Altimmune’s ongoing collaboration with the University of Alabama at Birmingham (UAB) and expand upon earlier preclinical data presented for the AdCOVID program

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