Biopharma Update on the Novel Coronavirus: May 19

CV Update_May 19

News information is not all-inclusive. Please check back for updates.


FDA Actions

Warning Letters: The FDA issued warning letters to Noetic Nutraceuticals and The Golden Road Kratom for selling fraudulent COVID-19 products.

Assess Supplies of Hydroxychloroquine and Chloroquine: The FDA, last week, approved another ANDA for Hydroxychloroquine Sulfate Tablets USP, 200 mg for malaria, Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults and acute and chronic RA. The FDA is working with manufacturers to assess their supplies and evaluating the market demand.

Diagnostics Update: The FDA has worked with more than 400 test developers who have submitted or plan to submit EUA requests to detect COVID-19. Also, 103 individual EUAs have been issued, which includes 90 molecular tests, 12 antibody tests and 1 antigen test.



The Centers for Disease Control and Prevention (CDC) is on the cusp of launching a massive, 25-city SARS-CoV-2 antibody study. Expected to launch in June or July, the study plans to test as many as 325,000 people to learn how the SARS-CoV-2 virus is spreading nationally, according to Reuters, reporting before the official announcement.


Testing Therapies, Antivirals and Vaccines

Dynavax indicated positive results from an early COVID-19 vaccine trial and hope to start and early-stage clinical trial as soon as July, as reported by the San Francisco Business Times.

The FDA authorized two Emergency Compassionate Use Investigational New Drug applications for a potential COVID-19 treatment under development from Organicell Regenerative Medicine. Two patients received the company’s Organicell Flow, an acellular product derived from amniotic fluid developed to potentially promote tissue homeostasis and repair. Earlier this month, the FDA approved the company’s IND for Organicell Flow for patients diagnosed with moderate to severe acute respiratory syndrome (SARS) due to COVID-19. 

CytoDyn announced it will be coordinating with the NIH of Mexico and providing leronlimab for a clinical trial for severe/critical COVID-19 patients in Mexico with the potential to collaborate on further CytoDyn COVID-19 trials. CytoDyn is currently enrolling a Phase IIb/III clinical trial for 390 patients, as well as a Phase II trial with 75 patients.

Innovation Pharma (formerly known as Cellceutix) announced that its COVID-19 drug candidate, Brilacidin, reduced the viral titer of SARS-CoV-2 by 75% after only 1 hour of preincubation prior to infection. This experiment was conducted in vitro.


Company Actions

Phlow Corp. and the Biomedical Advanced Research and Development Authority (BARDA) announced a contract worth up to $812 million to build a stockpile of key ingredients used in drug manufacturing and. The deal also included plans to manufacture medications for the nation’s strategic stockpile.

On the day after Moderna announced positive COVID-19 vaccine results, it will try to raise $1.34 billion with an underwritten public offering.

Health tech company Aetion and the U.S. Food and Drug Administration signed a collaboration agreement to use real-world data to advance the understanding of and response to COVID-19, the novel coronavirus that continues to sweep across the globe. 

10X Genomics and OneMedical are partnering to deploy a comprehensive approach to COVID-19 testing, digital employee symptom screening, and access to remote and in-person care to make it easier for employees to return to work. 10X has also teamed up with the Translational Genomics Research Institute (TGen), an affiliate of the City of Hope, for clinical testing of nasal swabs. One Medical’s workplace reentry program is called Healthy Together.

Fluidigm Corporation announced that the University of Paris researchers have leveraged mass cytometry to identify profound changes in the immune systems of critically ill COVID-19 patients. They believe this might help define a population of COVID-19 patients at high risk of becoming critically ill and perhaps offer a possible benefit from anti-inflammatory therapies. The testing utilized the Fluidigm Maxpar Direct Immune Profiling Assay and Maxpar Pathsetter analysis software.


Other Industry News

In a study published in Nature, AI algorithms were used to integrate chest CT findings with clinical symptoms, exposure history and lab testing to quickly diagnose patients who are COVID-19 positive.

As reported by the Wall Street Journal, President Trump said he is taking an antimalarial drug, hydroxychloroquine, as a possible defense against COVID-19. However, scientists warned that further study is needed and this could be dangerous.

According to a study published in the International Journal of Infectious Diseases, the median duration of viral shedding in patients with COVID-19 outside of Wuhan was 17 days.

Drug manufacturing in Italy will see something of a slowdown due to the impact of COVID-19. According to GlobalData, Italy is a major active pharmaceutical ingredient (API) supplier to the global market, and its stringent lockdown measures have caused disruption of the supply chains that relied on this manufacture during lockdowns.

Johns Hopkins University initiated a free course on Coursera, COVID-19 Contact Tracing, to help meet an urgent need for more contact tracers in the United States. In one week, more than 150,000 people have enrolled in the course. More than 22,000 have completed it, including 2,500 prospective contact tracers who could be employed by the state of New York.

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