Biopharma Update on the Novel Coronavirus: April 29

CV Update_April 29

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FDA Actions

Generic Drug Applications: The FDA posted information and resources to help manufacturers when submitting drug applications with bioequivalence studies during the COVID-19 pandemic.

Warning Letters: The FDA and FTC issued warning letters to Hopewell Essential Oils and Santiste Labs LLC for selling fraudulent COVID-19 products. There are currently no products FDA approved for the treatment of COVID-19.

Diagnostics Update: The FDA has worked with more than 380 test developers who plan to submit EUA requests to detect COVID-19. Also, 50 individual EUAs have been issued. In addition, 22 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 230 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.



Medical Diagnostic Laboratories, L.L.C., has expanded its testing to include serological testing for COVID-19 antibodies in human serum.

Novacyt reported that its UK molecular diagnostics division, Primerdesign, had sold, received orders for, or been contracted to deliver 103 million euros of its COVID-19 test. It is now supplying the test to more than 100 countries, with approvals most recently in Malaysia and Ecuador. It expects to increase manufacturing capacity to 8 million tests per month.

LabCorp, one of the two largest clinical diagnostic lab companies in the U.S., announced first first-quarter results, with revenue of $2.82 billion, up 1% over last year’s Q1 results.  The company reported overall customer caution in regards to the pandemic, with overall demand for testing declining 50% to 55% over the normal daily levels, largely for routine testing. It expects that to be somewhat offset by increasing capacity for its COVID-19 Serological Antibody tests to over 200,000 tests per day by mid-May in addition to increasing capacity for its Molecular COVID-19 tests, including its at-home test kit.

Centene and Quest Diagnostics partnered to increase access to real-time reverse transcription polymerase chain reaction COVID-19 testing in critical areas of need. Centene will facilitate the distribution of 25,000 Quest COVID-19 test kits each week to Federally Qualified Health Centers in 10 states. Centene will provide oversight and training to ensure test kits are received and processed efficiently. Distribution of kits will begin May 4, and Quest Diagnostics will conduct the COVID-19 testing through its network of laboratories across the United States.

Current Health launched a collaboration with Mayo Clinic to develop remote monitoring solutions that accelerate the identification of COVID-19-positive patients and predict symptom and disease severity in patients, healthcare workers and other at-risk individuals in critical service sectors. Digital biomarkers collected by remote monitoring sensors will be used to expedite identification and assessment of treatment efficacy and improve care for patients with or at risk of COVID-19 infection.


Testing Therapies, Antivirals and Vaccines

Pfizer and Germany-based BioNTech are collaborating on a messenger RNA vaccine against SARS-CoV-2, the novel coronavirus that causes COVID-19. The two companies have already begun Phase I/II clinical testing in Germany. The companies now plan to start testing in the U.S. once the U.S. Food and Drug Administration (FDA) gives approval.

Gilead Sciences report encouraging results from its clinical trial of remdesivir in COVID-19. The company announced topline results from the open-label, Phase III SIMPLE trial looking at 5-day and 10-day dosing of the drug in hospitalized patients with severe disease. It also reported positive data from the National Institute of Allergy and Infectious Diseases’ (NIAID) trial of the drug in COVID-19.

Huntsville Hospital, HudsonAlpha Institute for Biotechnology, and iRepertoire are studying local COVID-19 patients under a Huntsville Hospital IRC approved protocol to evaluate the human immune system response to SARS-CoV-2 in hopes of developing a treatment for the disease. The patients will provide blood samples at four time periods of several weeks to evaluate how their immune system is responding.

Capricor Therapeutics announced new data showing 100% survival in critical COVID-19 patients treated with its allogeneic cardiac cell therapy CAP-1002 at Cedars-Sinai Medical Center in six compassionate care cases. As a result, the FDA approved its expanded access protocol to treat up to 20 more COVID-19 patients. CAP-1002 shows immunomodulatory properties.

Strides Pharma Science, an Indian company, announced that it has developed and commercialized Favipiravir Antiviral tables that have shown positive outcomes in COVID-19. The drug has shown a reduction in the duration and improved lung conditions in COVID-19 patients.


Company Actions

ProteoGenix announced the availability of the Human Immune COVID-19 library. The library was created using blood samples from recovered COVID-19 patients to help assist with the fast discovery of potent antibodies against SARS-CoV-2.

Catalent announced a collaboration with Janssen Pharmaceutical, a division of Johnson & Johnson, to accelerate manufacturing capacity and prepare for large-scale commercial manufacturing of Johnson & Johnson’s lead vaccine candidate for COVID-19. Catalent plans to hire approximately 300 additional employees at the site for this program starting in July 2020 to meet operational readiness and round-the-clock manufacturing schedules by January 2021.


Other Industry News

A recent report from China revealed that the infection rates between adults and children were similar, but men are more likely to exhibit severe symptoms caused by COVID-19. The study also highlights the importance of contact tracing to help mitigate infection rates following the revelation through tracing efforts that the majority of infected patients infected one person. 

The chairman of Alexandria Real Estate Equities, one of the most well-known Life Sciences landlords, revealed how COVID-19 will change the landscape for operating laboratories, as well as the construction of large campuses in the future. In an interview with the Boston Business Journal, Joel Marcus discussed the impact the pandemic is having on the life sciences real estate industry and how the disease has impacted its LaunchLabs facilities.

Diaceutics announced research from its newly-launched COVID-19 oncology tracker found that the virus is having a devastating impact on cancer diagnoses and biomarker testing in the United States. Diaceutics’ research found that lung cancer diagnoses fell 31% from February to March 2020, while diagnosis rates for cancers including colorectal, breast and ovarian were also down. The research also uncovered declines in certain biomarker tests.

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