Biopharma Update on the Novel Coronavirus: May 11

CV Update_May11

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FDA Actions

COVID-19 Antigen Test: The FDA has issued the first EUA to Quidel Corporation for a COVID-19 antigen test. The diagnostic tests detect fragments of proteins found on or within the virus.

First Diagnostic Test with Saliva: The FDA authorized the first diagnostic test for COVID-19 with the option of using home-collected saliva samples. The EUA was given to Rutgers Clinical Genomics Laboratory.

Warning Letters: The FDA and FTC issued warning letters to Sanit Technologies LC dba Durisan, AgroTerra Ltd. dba Patriot Hemp Company, WashingtonsLastFrontier.com and Chronic Lyme Treatments for selling fraudulent COVID-19 products.

EUA: The FDA issued a EUA for the Duke Decontamination System to decontaminate compatible N95 or N95-equivalent respirators to help health care personnel. This is the sixth system that has been authorized.

Lidocaine Hydrochloride Injection USP, 1%: The FDA approved and Abbreviated New Drug Application for lidocaine hydrochloride injection USP, 1%. This drug is listed in the FDA Drug Shortage Database and is indicated for production of local or regional anesthesia.

Diagnostics Update: The FDA has worked with more than 385 test developers who plan to submit EUA requests to detect COVID-19. Also, 65 individual EUAs have been issued. In addition, 25 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs). 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.

Diagnostics

Abbott Laboratories has won Emergency Use Authorization for another COVID-19-related diagnostics test for antibodies. This morning, the company said the U.S. Food and Drug Administration approved its SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system.

U.K.-based Mologic. and BioSure joined forces to produce a COVID-19 antibody self-test. The companies will combine Mologic’s independently verified COVID-19 lateral flow test with BioSure’s self-test design. The design requires only a fraction of a drop of blood and gives the user their own result in just 10 minutes. The BioSURE COVID-19 Antibody Self-Test will be ready for mass production at the beginning of June. It will be available to the UK and global markets and will also be available to be directly purchased by end-consumers.

G2 Intelligence, which focuses on clinical diagnostic testing, issued a report on COVID-19 testing that includes an updated list of the 89 COVID-19 laboratory tests that have received FDA Emergency Use Authorization to date.

Todos Medical entered into an exclusive distribution deal with Gnomegen to distribute its digital and quantitative PCR COVID-19 test kits in North America, Europe, Southeast Asia and Latin America. Also, the company announced that Genomegen’s qPCR test received EUA from the FDA on May 8. The kit completed validation testing for the Gnomegen qPCR reagents and is now preparing to launch the test in the U.S. through its partner CLIA lab.

Three-drug antiviral cocktail of AbbVie’s Kaletra (protease inhibitor lopinavir-ritonavir), nucleoside analogue ribavirin, and injectable interferon beta-1b (Bayer’s Betaseron; Novartis’s Extavia), significantly decreased the median time to a negative SARS-CoV-2 test compared to controls in a small Phase II trial. The cocktail appeared to cut the median number of days from 12 days in the control group to seven days. The study was published in The Lancet.

Testing Therapies, Antivirals and Vaccines

Bellerophon Therapeutics announced that the FDA has accepted its Investigational New Drug (IND) application to initiate a Phase III clinical trial of INOpulse® inhaled nitric oxide (iNO) therapy in up to 500 patients infected with COVID-19.

As reported by CNBC, BioAegis feels that is lead product is a viable treatment option for COVID-19 patients with severe lung injury. The company is awaiting FDA approval to accelerate its clinical trial of recombinant human plasma gelsolin therapy.

Company Actions

As reported by Reuters, last Friday, Pfizer said it will plan to shift more of its drug production and outsource as it prepares for large-scale production of an experimental vaccine to prevent COVID-19, once it is proved to be safe and effective.

Reuters reported that the Trump administration outlined its plan to distribute Gilead Sciences’ remdesivir. The HHS will ship 14,400 vials of the drug to state health departments. Gilead committed to supplying 607,000 vials over the next six weeks.

Premier Biotech is one of four companies under investigation by a U.S. House subcommittee regarding concerns that their COVID-19 testing is not as accurate as what is claimed. According to the StarTribune, Premier Biotech is standing by the accuracy of its tests and claims it has been validated by outside researchers.

Other Industry News

Avacta Group plc is shipping Affimer reagents for COVID-19 antigen testing to its diagnostic test development partners. The Group recently reported that it had generated multiple, highly specific Affimer reagents that bind the SARS-COV-2 viral antigen and do not cross-react with SARS, MERS and other closely related coronaviruses. These Affimer reagents will be used to develop a point-of-care saliva-based COVID-19 antigen test strip by Cytiva (formerly GE Healthcare Life Sciences) for CE marking in Europe and FDA approval in the United States.

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