Biopharma Update on the Novel Coronavirus: May 14

CV Update_May 14

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

FDA Actions

Virtual Town Hall: The FDA will host a virtual Town Hall on May 15. This town hall will be for researchers, clinical labs and commercial manufacturers to discuss production and use of 3D printed swabs during the pandemic.

Diagnostics Update: The FDA has worked with more than 390 test developers who plan to submit EUA requests to detect COVID-19. Also, 95 individual EUAs have been issued, which includes 82 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.

Diagnostics

A NYU study shows Abbott’s ID NOW test failed to detect nearly half of positive COVID-19 cases but the Illinois-based company is questioning the results and methodology of the study. Abbott said the results are in sharp contrast to the high rate of specificity its ID Now test has demonstrated in other studies. 

Testing Therapies, Antivirals and Vaccines

As reported by NBC News, Cuba is betting its biotech community can give it an edge in the global race to find effective treatments for COVID-19. The country is touting an interferon-alpha 2b drug that it produces. Interferon is an old antiviral agent that boosts the immune system.

Kaleido Biosciences initiated a controlled clinical study evaluating Microbiome Metabolic Therapy (MMT) candidate KB109 along with Supportive Self-Care (SSC) for outpatients who are positive for SARs-Cov-2 infection with mild-to-moderate COVID-19. The study will enroll approximately 400 outpatients with mild-to-moderate disease in two non-IND clinical studies that are designed to evaluate the effects of Supportive Self-Care (SSC) plus KB109 compared to SSC alone.

France’s Abivax SA received clearance from French regulatory authorities to conduct a Phase IIb/III trial of ABX464 to prevent severe inflammation that leads to acute respiratory distress syndrome (ARDS) in 1,034 COVID-19 elderly or high-risk patients. ABX464 demonstrated efficacy in a Phase 2a trial in another severe inflammatory disease, ulcerative colitis.

The Autonomous University of Mexico is harnessing data from its Dengue and Zika vaccine studies in hopes of developing a vaccine against COVID-19.

Company Actions

Sanofi backed off of comments that said the United States will get first access to its COVID-19 vaccine. On Thursday, Sanofi ensured that when ready, its COVID-19 vaccine would be available in all countries.

As reported by Forbes, the World Health Organization has warned that COVID-19 may become another endemic virus in our communities and that even with a vaccine the virus may not be eliminated.

Other Industry News

The White House tapped former GlaxoSmithKline vaccines executive Moncef Slaoui to helm the administration’s “Operation Warp Speed” initiative, which has a goal of developing and distributing hundreds of millions of doses of a vaccine against COVID-19. Slaoui retired from GSK in 2017 after helping develop a number of vaccines for shingles and other illnesses.

The U.S. government has expressed concerns that Chinese hackers may be trying to steal data related to COVID-19 vaccine and treatment research. No specific examples were provided as the war of words between the two countries continues to escalate, Voice of America reported.

Boston University scientists snagged $1.9 million from the Massachusetts Consortium on Pathogen Readiness to advance COVID-19 research. Since the virus reached pandemic levels, BU’s National Emerging Infectious Diseases Laboratories have dropped nearly every other research project to focus on understanding and combating the virus, according to Mirage.

Haven Chief Executive Officer Atul Gawande is stepping down from that role in order to devote time to battling COVID-19. Gawande will remain chairman of the board of directors. A search for a new CEO is underway. According to the Boston Business Journal, Gawande said stepping down will “free him up to devote time to policy and other activities surrounding the immediate and long-term threats to the health care system posted by the ongoing coronavirus pandemic.”

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