Biopharma Update on the Novel Coronavirus: May 5

CV Update_May 5

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FDA Actions

Updated Policy: The FDA has updated policy from March 16, 2020, on antibody tests for COVID-19. The FDA posted Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy to explain the policy update.

Authorization of a Serology (Antibody) Test: The FDA authorized the first serology test where the results of a new independent validation effort by the U.S. Government provided scientific evidence performed at the Frederick National Laboratory for Cancer Research. The results came from a collaborative effort by the FDA, NIH, CDC and BARDA to evaluate certain serological tests.

Warning Letters: The FDA issued warning letters to two websites, and that have marketed unapproved COVID-19 products.

Diagnostics Update: The FDA has worked with more than 380 test developers who plan to submit EUA requests to detect COVID-19. Also, 58 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 235 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.



Bio-Rad Laboratories announced that its SARS-CoV-2 Droplet Digital PCR (ddPCR) test kids was granted a EUA by the FDA. The test is highly sensitive well suited to screening upper respiratory samples in patients with a low viral load including those in the early stages of infection. 

PerkinElmer received EUA for EUROIMMUN’s Anti-SARS-CoV-2 ELISA (IgG) serology test. EUROIMMUN is a PerkinElmer company. The company has the capacity to manufacture millions of assays per month.

Stilla Technologies announced its digital PCR solution, the Naica system, is now available to all research centers and hospitals in the battle against COVID-19. The system can reliably detect the SARS-CoV-2 virus and measure its viral load.

As reported by the Boston Business Journal, Siemens Healthineers AG said that around 800 employees in the company’s Walpole facility are preparing to make 25 million antibody tests to help track the COVID-19 virus. The test will be available to the public by late May.


Testing Therapies, Antivirals and Vaccines

Pfizer and BioNTech SE announced that in the U.S. the first participants have been dosed in a Phase ½ clinical for the BNT162 vaccine program for COVID-19. The dosing of the first cohort in Germany was completed last week.

ioTech International indicated that three of its products, ioRinse Oral Rinse, ioCleanse Hand Cleanser and ioMist Nasal Spray, based on its non-staining formulations of molecular iodine, are being used in a clinical trial at St. Joseph’s Hospital University Medical Center in Patterson, New Jersey. The endpoint of the six-week study is a reduction in COVID-19 symptoms from healthcare workers using the products that are treating COVID-19 patients.

On Monday, Emergent BioSolutions CEO, Robert Kramer told CNBC that nobody can guarantee anything and it is uncertain if a COVID-19 vaccine can be available by the end of the year. Emergent is working on a COVID-19 vaccine candidate with Johnson & Johnson and hopes to receive emergency use authorization in 2021.

The FDA approved an Investigational New Drug Application for Organicell Regenerative Medicine’s lead product, Organicell Flow, for patients diagnosed with moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection. The company will initiate a Phase I/II study of the acellular product derived from amniotic fluid. 

As reported by CNBC, the World Health Organization (WHO) said it will discuss with Gilead Sciences and the U.S. government to determine how remdesivir could be made more widely available to treat COVID-19.

California-based CohBar, Inc. initiated preclinical testing of its CB5064 analogs to assess their potential as therapeutics for COVID-19-associated ARDS. In preclinical studies to date, these peptides have demonstrated the ability to activate the apelin receptor, which can reduce the severity of acute lung injury by reducing lung fluid accumulation, hypoxemia, and cytokine secretion, which occur in COVID-19 associated ARDS, and lead to downstream injury to the kidney, heart, and other organs.


Company Actions

Luminex returns to profitability, partially due to COVID-19Luminex, a developer of molecular diagnostics and clinical tools for the life sciences industry, returned to profit this quarter – well ahead of schedule – after a major client, LabCorp, departed in 2019.

Ajinomoto Bio-Pharma Services entered into a manufacturing services agreement with CytoDyn for CytoDyn’s leronlimab, which is being evaluated in clinical trials for mild-to-moderately ill and severely ill COVID-19 patients. Aji provides high-quality drug product aseptic fill-finish services for CytoDyn.

In its quarterly report, Incyte said there has been no impact from COVID-19 on the commercial side of the business, and Incyte currently has ample commercial and clinical supply of our medicines to meet the needs of patients. The company said it has increased manufacturing for ruxolitinib as it assesses the drug against COVID-19. Incyte initiated a Phase III clinical trial to evaluate ruxolitinib plus standard-of-care (SoC), compared to SoC therapy alone, in patients with COVID-19 associated cytokine storm.

Tetra Bio-Pharma is seeking funding for research that will support studies of its synthetic cannabinoid drug PPP003 in COVID-19 patients. The company believes the treatment that selectively acts at the type 2 cannabinoid receptor (CB2R) can reduce organ inflammation and dampen pro-inflammatory cytokine release which may help reduce symptoms of acute lung inflammation and immune system overactivity that lead to sepsis.

Arrayjet repurposed its facilities to help against the COVID-19 fight and assist scientists to better understand the behavior of the virus. Arrayjet formed a collaborative partnership with CDI Laboratories for this project.


Other Industry News

Leaders from all over the world met for a virtual summit on Monday, May 4 to pledge billions of dollars to fund the development of a vaccine against COVID-19, the disease caused by the novel coronavirus SARS-CoV-2. Noticeably absent was the United States.

Dr. Anthony Fauci, who has been considered one of the most trusted leaders tackling the COVID-19 pandemic in the United States, once again stressed that, as far as the evidence suggests, the novel coronavirus is naturally occurring and was not made in a laboratory. Additionally, Fauci pointed to vaccine candidates that, so far, are showing great potential against COVID-19. 

The Institute for Clinical and Economic Review (ICER) conducted an analysis to inform public debate for pricing for Gilead Sciences’ remdesivir and other future treatments for COVID-19. They basically developed two alternative pricing paradigms. The first is “cost recovery” for the manufacturer, an estimate based on peer-reviewed methods of calculating the minimum costs of production for the therapy, and traditional cost-effectiveness analysis evaluating the incremental health benefits and costs within the health system. The cost recovery model came up with $10 for a 10-day course and $5 for a 5-day course. The traditional model suggested a $4,500 per treatment course.  

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