Biopharma Update on the Novel Coronavirus: May 15

CV Update_May 15

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FDA Actions

EUA: The FDA issued a EUA for infusion pumps and infusion pump accessories in response to concerns about insufficient supply and availability during the COVID-19 pandemic.

Update for Pharmacy Compounders: The FDA issued an update to its temporary guidance for pharmacy compounders who experience shortages of PPE they typically use. The FDA clariid that drugs can be compounded in a segregated compounding area that is not in a cleanroom when specific beyond-use dates are utilized.

Temporary Restraining Order: A federal court has entered a temporary restraining order against Xephyr LLC, dba N-Ergetics requiring them to immediately stop distributing colloidal silver products offering to treat coronavirus.

Diagnostics Update: The FDA has worked with more than 390 test developers who plan to submit EUA requests to detect COVID-19. Also, 98 individual EUAs have been issued, which includes 85 molecular tests, 12 antibody tests and 1 antigen test. The FDA has been notified that more than 245 laboratories have begun testing under the policies set forth in its COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.



Following a study that raises concerns about the accuracy of Abbott’s rapid COVID-19 test for detecting the virus, the U.S. Food and Drug Administration announced it will investigate the claims found in a New York University-related study as the company updates its guidance on the ID NOW test.


Testing Therapies, Antivirals and Vaccines

Sorrento Therapeutics announced that one of its antibodies, STI-1499, has shown 100% inhibition of SARS-CoV-2 in laboratory tests.

According to the World Health Organization and, there are currently 1,114 ongoing clinical studies of treatments for COVID-19. A GlobalData analysis indicates that so far, 21 of the trials have reported interim results, and out of them, 16 showed positive early results.

Germany-based VSY Biotechnology GmbH touted a new drug developed in-house to treat COVID-19. Laboratory studies have shown that TR-C 19, developed by VSY’s R&D team, can neutralize the novel coronavirus. The company now plans to advance this study into clinical trials.

Avacta Group plc announced that Affimer® reagents recently generated for the development of COVID-19 antigen saliva tests have now also been shown to block the interaction between the virus’ spike protein and ACE2. ACE2 is a receptor on human cells that is key to the virus infection pathway.


Company Actions

Earlier this week, Sanofi’s chief executive officer Paul Hudson indicated that the U.S. would have first access to its COVID-19 vaccine because of the significant financial support it is receiving from the U.S. government. This raised a furor in other countries, particularly France, where the company is headquartered, and the UK, where its partner in the vaccine endeavor, GlaxoSmithKline, is located. Sanofi is now backing away from the pledge, where Hudson had said that because of the U.S.’s Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS), funding, “The U.S. government has the right to the largest preorder because it’s invested in taking the risk.”

Medigus signed an exclusive distribution deal with Elbit Systems Land. Elbit manufactures LifeCan, a pandemic response ventilator. Medigus will obtain exclusive rights from Elbit for marketing of sale of the product to Mexico.

CytoDyn is offering comprehensive cytokine profiling through its diagnostic partner company, IncellDx, to help doctors understand the hpathogenesis of Childhood Inflammatory Disease Related to COVID-19. They are exploratory and not intended for clinical decision making.


Other Industry News

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones, including a 3-drug cocktail that decreases COVID-19. 

A poll conducted by Opinium regarding trust during the pandemic found that Dr. Anthony Fauci was more trusted than President Donald Trump. According to the poll, which was released this morning, 70% of Americans trust Fauci on COVID-19 matters, while 40% trust the president. Fauci is trusted by more than 70% of both Democrats and Republicans whereas trust in the president splits sharply along party line, Adam Drummond, head of political polling at Opinium, said in a statement.

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