Biopharma Update on the Novel Coronavirus: May 21

CV Update_May 21

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


FDA Actions

EUA: The FDA issued a EUA for the COVID-19 Airway Management Isolation Chamber (CAMIC). The EUA was given to Walter Reed National Military Medical Center and the equipment will be used by healthcare providers in the U.S. Army and Military Health System.

Warning Letters: The FDA and FTC issued warning letters to Life Unlearned, LLC and SpiceTac for promoting and participating in the sale of fraudulent COVID-19 products.

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, 105 individual EUAs have been issued, which includes 92 molecular tests, 12 antibody tests and 1 antigen test.



Sherlock Biosciences announced that Open Philanthropy is advancing $7.5 million in grants to launch the Sherlock innovation Lab to accelerate the development of the company’s at-home COVID-19 diagnostic that uses its INSPECTR platform. Last year, Open Philanthropy awarded the company $17.5 million to develop the SHERLOCK platform for at-home use, as well as for hospitals and in the field.


Testing Therapies, Antivirals and Vaccines

UK company AstraZeneca has partnered with the University of Oxford’s COVID-19 vaccine efforts. Today, the company announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) paid more than $1 billion to support the development, production and delivery of the vaccine beginning this fall. The development program will include a Phase III clinical trial with 30,000 people, as well as a trial in children.

While billions of dollars have been aimed at developing a potential vaccine and having it in the hands of people by the end of 2020 or in early 2021, experts are calling for caution that safety and efficacy are not being overlooked in the zeal to rush a vaccine into commercialization. 

Yale University launched a clinical trial of ibudilast (MN-166) to assess it as a treatment for COVID-19 patients with acute respiratory distress syndrome. The drug, which has been approved in Japan for asthma, has anti-inflammatory and neuroprotective effects and suppresses the production of pro-inflammatory cytokines. In mouse models it has been shown to decrease inflammation related to ARDS. 

New Jersey-based ADMA Biologics has begun collecting convalescent plasma through its wholly-owned subsidiary, ADMA BioCenters Georgia Inc. from individuals who have recovered from COVID-19. The plasma will be used to produce an immune globulin to potentially help infected patients with COVID-19.

CalciMedica announced the FDA had strongly recommended the company transition its clinical trial of Auxora in COVID-19 pneumonia from the randomized open-label study to a blinded placebo-controlled trial ASAP. This was after an interim analysis. Auxora is a potent and selective small-molecule CRAC channel inhibitor that prevents CRAC channel overactivation.

There is a positive sign for the COVID-19 vaccines in development. On Wednesday, two studies published offered some of the first scientific evidence that surviving COVID-19 could result in immunity from reinfection. The studies, published in the journal Science indicate that the vaccines in development may be successful.

As reported by ABC News, a small British-Norwegian company, BerGenBio has developed a drug called bemcentinib and is being tested to see its potential to treat COVID-19. The drug was initially developed to treat cancer, but BerGenBio feels it may be effective to fight COVID-19.


Company Actions

Tianjin, China’s CanSino Biologics entered into a co-development agreement with Vancouver, British Columbia’s Precision NanoSystems (PNI) for an mRNA lipid nanoparticle vaccine against COVID-19.

Indica Labs and Octo partnered for the online COVID Digital Pathology Repository (COVID-DPR), a virtual collection of high resolution microscopic COVID-related human tissue images. The repository is hosted at the National Institutes of Health (NIH).

As reported by Reuters, AstraZeneca plans one billion doses if their experimental COVID-19 vaccine is successful and the United States has secured almost a third of it – 300 million.

Aldeyra Therapeuticsstock climbed 13.8% Wednesday after the company said its experimental coronavirus treatment, ADX-1612, could be more effective than Gilead Sciences’ remdesivir. To date, ADX-1612 has only been tested on human cells in the laboratory, where it beat out remdesivir in a measure of potency. ADX-1612 was originally being developed for ovarian cancer.


Other Industry News

Medtech company ClearStar, which specializes in background and medical screening, announced the launch of a testing service aimed at supporting employers with their COVID-19 return-to-work planning and keeping their workforce safe. The new service is provided by ClearStar’s Medical Information Services business through Clinical Reference Laboratory, Inc., one of the largest privately-held clinical testing laboratories in the U.S.

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