Biopharma Update on the Novel Coronavirus: September 28

CV Update_September 28

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) has placed a partial clinical hold on Inovio Pharmaceuticals' planned Phase II/III Covid-19 vaccine clinical trial. The company said the regulatory agency has additional questions about the Phase II/III trial regarding the vaccine candidate itself, known as INO-4800, as well as the company’s Cellectra 2000 delivery device.


Clear Labs received Emergency Use Authorization from the FDA for its Clear Dx SARS-CoV-2 novel descriptive diagnostic. The system extends available options for labs to scale infectious disease diagnostic testing.

The FDA granted Emergency Use Authorization (EUA) to Hologic's Panther Fusion® SARS-CoV-2 assay for the testing of asymptomatic individuals. The assay is the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people.

Testing Therapies, Antivirals and Vaccines

Johnson and Johnson posted an interim analysis of its Phase I/IIa trial that showed a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants and was well-tolerated. The company said the presence of antibodies to COVID-19 was observed in 99% of participants aged 18-55 years of age.

FSD Pharma, based in Toronto, initiated a Phase II study for the use of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat COVID-19. The company is expected to start dosing patients in October 2020. FSD201 may have the potential to address the over-exuberant inflammatory response characterized by COVID-19 infection that may lead to a cytokine storm and ultimately death.

IONTAS and FairJourney Biologics announced the discovery of potent SARS-CoV2 neutralizing antibodies as potential therapeutics for COVID-19. The newly-identified panel of antibodies have been shown to block infection at doses as low as 20pM in pseudoviral assays and 100pM in live coronavirus assays, according to the companies.

Company Actions/Announcements 

Novavax announced that it will present the latest research involving their lead vaccine candidates, NVX-CoV2373, NanoFlu™ and ResVax™, the company’s COVID-19, influenza and respiratory syncytial virus (RSV) vaccines. The presentations will be part of the 2020 World Vaccine Congress Washington.

Other Industry News

Scott Gottlieb, the former commissioner of the U.S. Food and Drug Administration, is urging U.S. residents to take precautions this autumn due to increasing COVID-19 infections across 30 states and the looming cold and flu season. On Face the Nation, Gottlieb said hospitalization rates in the United States for COVID-19 had been in a state of decline, but those numbers are now rising, which goes hand in hand with an increase in infection rates.

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