Biopharma Update on the Novel Coronavirus: April 17
News information is not all-inclusive. Please check back for updates.
It seems completely logical that as the U.S. Food and Drug Administration (FDA) shifts much of its focus to the COVID-19 pandemic, some of its other duties will slow. The agency issued a statement saying that it will continue its activities, such as reviewing new drug applications and clinical trial, both COVID-19 and non-COVID-19, applications, “as we do everything possible to maintain continuity of operations in a very dynamic situation.”
User Fee Programs: The FDA continues to perform its user fee review activities and application review teams remain focused on their work.
- Center for Drug Evaluation and Research / Center for Biologics Evaluation and Research (CBER): Staff is working diligently to address COVID-19 challenges and to carry out on-going duty. At this time, programs are continuing to meet key review program user fee performance goals. However, it is possible that programs will not be able to sustain current levels of performance indefinitely. Programs are ready to reprioritize as necessary.
- Center for Devices and Radiological Health (CDRH) and CBER: Staff is continuing to meet all of their Medical Device user Fee Amendments (MDUFA) review goals. CDRH is further extending response due dates for marketing applications by 90 days for certain notifications and approval applications. With a good portion of the CDRH working on COVID-19 activities, it is possible they will not be able to sustain current levels of performance indefinitely and will be assessed on an ongoing basis.
Compounding of Certain Drugs: The FDA issued guidance implementing a temporary policy during the COVID-19 public health emergency for outsourcing facilities to compound certain drugs for hospitalized patients.
Q&A on Clinical Trials: The FDA updated content to the Q&A in its guidance for the conduct of clinical trials of medical products during the COVID-19 public health emergency.
Telethermographic Systems: The FDA issued guidance for the expanded availability of telethermographic systems. These systems are used for triage use taking body temperature measurements and the potential use in high traffic areas such as airports, businesses, warehouses and factories.
Warning Letters: The FDA issued two warning letters to Fishman Chemical of North Carolina, LLC., and Dr. G’s Marine Aquaculture as they sell chloroquine phosphate products for aquarium fish. The companies have not made claims for their products use in humans, but the FDA is concerned consumers may mistake it for human drug chloroquine phosphate.
The FDA and FTC issued a warning letter to The Art of Cure, for selling fraudulent COVID-19 products.
Diagnostics Update: The FDA has worked with more than 315 test developers who plan to submit EUA requests to detect COVID-19. Also, 37 EUAs have been issued. The FDA has been notified that more than 190 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.
Roche: Swiss pharma giant Roche is joining the race to develop a test for COVID-19 antibodies in people who have been exposed to the disease. This morning, Roche announced the development and upcoming launch of its Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the SARS-CoV-2, the virus that causes COVID-19.
IDTechEx issued a report on COVID-19 Diagnostics, noting that the demand for testing is expected to be over 600 million tests including 120 million genetic tests and more than 500 million rapid tests. This has led to a race for technology innovations. The report examines and analyzes the technology landscape and technology being used.
Testing Therapies, Antivirals and Vaccines
Moderna: As Moderna moves forward with its mRNA vaccine candidate for COVID-19, the U.S. federal government is helping accelerate the potential medication with a $483 million infusion from the Biomedical Advanced Research and Development Authority (BARDA).
Gilead Sciences: Although not official and largely anecdotal, there are early signs that Gilead Sciences, Inc.’ experimental antiviral drug, remdesivir, is effective in treating COVID-19. The company has conducted at least five trials, although at least one in China was halted because of lack of patients to enroll. And Gilead recently published data in the New England Journal of Medicine on 53 patients who received the drug under a compassionate use basis that suggested promising results.
There could be a lead on a potential new treatment for COVID-19 based on an anecdotal report that showed a patient treated with extracorporeal membrane oxygenation (ECMO) therapy recovered. ECMO is used to pump and oxygenate the patient's blood outside the body, replacing the function of the lungs and heart. Within 10 days the patient was off a ventilator but remained hospitalized. According to MedPage Today, 370 COVID-19 patients are on ECMO across the globe, with the majority in North America.
A joint project between Northeastern University’s Barabasi Labs, Harvard Medical School, Stanford, Network Science Institute and biotech startup Scipher Medicine is deploying principles of network medicine to identify generic drugs that can quickly be repurposed as COVID-19 treatments. The program identifies drug pathways and drug targets that are linked or overlapping –within the network vicinity – of viral disease pathways.
China-based Sinovac Biotech Ltd. initiated a Phase I clinical trial for its vaccine candidate against COVID-19. Enrollment of the first group of volunteers and the first dose of vaccination for these volunteers have been completed.
Pangea Laboratory announced it is testing 1,000 COVID-19 tests per day. Pangea’s SARS-CoV-2 testing service is validated for both throat swabs and sputum specimens, and test results are available within 24 hours of sample arrival. The company is investing in increased testing capacity in response to the ongoing coronavirus pandemic. Pangea attributes its high testing volume to a mission-driven team and strategic partnerships with local businesses to secure its supply chain.
Rensselaer Polytechnic Institute developed a machine learning model that can predict pandemic impact even in smaller cities, with 75% of the population in the Capital Region in New York remaining at home. This model suggested the pandemic will peak locally in the second half of May, but if that drops to 50%, it will peak in early June.
Switzerland-based Debiotech is collaborating with vaccine makers to use its DebioJect Microneedle, to improve the effectiveness of COVID-19 vaccines by reducing the necessary dose to achieve a sufficient immune response.
Other Industry News
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones including another promising COVID019 vaccine.
Kaitlyn Sadtler, head of the National Institutes of Health (NIH) Section on Immunoengineering, is leading the effort to discover previously unknown cases of coronavirus, Forbes reported. The NIH study has a goal of determining how many adults in the U.S. without confirmed cases of COVID-19 have antibodies to the virus.
A number of companies and life science organizations are using artificial intelligence to hasten the development of medications or the identification of symptoms and transmission related to the disease. Forbes put together a roundup of the different groups using AI.
Azithromycin tablets, better known by the brand name Z-Pack, a commonly prescribed antibiotic, is facing a shortage due to COVID-19 demands, The Hill reported. The antibiotic has been touted as a companion medication to the malaria drug hydroxychloroquine as a potential treatment for the disease. Some of the companies reporting shortages of the antibiotic don’t expect it to be resolved until July at the earliest, The Hill said.