Biopharma Update on the Novel Coronavirus: September 2
News information is not all-inclusive and updates are published on Mondays, Wednesdays and Fridays.
Warning Letter: The FDA and FTC have issued a warning letter to Lattice Biologics for marketing fraudulent products to treat SARS or ARDS related to COVID-19.
Diagnostics Update: To-date the FDA has authorized 235 individual EUAs, which include 190 molecular tests, 41 antibody tests and 4 antigen tests.
Testing Therapies, Antivirals and Vaccines
AstraZeneca announced that its Phase III clinical trial of its COVID-19 vaccine candidate, AZD1222, is expanding into the U.S. It will be dubbed D8110C00001 and is funded by the Biomedical Advanced Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID). The NIAID-supported COVID-19 Prevention Network (CoVPN) is also participating.
Another Kevzara study in hospitalized COVID-19 patients failed to meet primary and secondary endpoints. This marks the second such failed study for Kevzara and at least the third with IL-6 inhibitors as a potential treatment for these patients. This week, Sanofi announced the disappointing results from the Phase III study of intravenously-dosed Kevzara (sarilumab).
The National Institutes of Health (NIH) released a statement on Tuesday on the emergency use authorization of convalescent plasma for the treatment of COVID-19. The statement reads, “There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19.”
As reported by CNBC, a group of U.S. Health Officials has predicted that four late-stage COVID-19 vaccine trials may fail to provide positive results. However, they also predicted that three will be successful. A study published in the journal Biostatistics indicates that vaccines for infectious diseases have a 33.4% success rate of making it to regulatory approval.
Avacta Group entered into an agreement with Abingdon Health for the manufacture of Avacta’s saliva-based rapid SARS-CoV-2 antigen test as part of its ongoing expansion of manufacturing capacity. Avacta, in partnership with Cytiva, is developing a rapid test strip for use with patient saliva that aims to provide a result in a few minutes, indicating whether the patient is currently infected with the SARS-CoV-2 coronavirus.
Following positive results in six COVID-19 patients treated with Zofin under emergency access, Florida-based Organicell Regenerative Medicine will enroll patients in a Phase I/II study to evaluate Zofin in moderate to severe COVID-19 patients.
Other Industry News
A group of researchers at Oak Ridge National Lab in Tennessee used the Summit supercomputer, the second-fastest in the world, to analyze data on more than 40,000 genes from 17,000 genetic samples related to COVID-19. The analysis took more than a week and analyzed 2.5 billion genetic combinations. And it came up with a new theory, dubbed the bradykinin hypothesis, on how COVID-19 affects the body.
The COVID-19 pandemic is changing the FDA irrevocably, resulting in a more dynamic, streamlined FDA that is more willing to embrace digital technology, according to panelists at the recent OC LIFe (Lifesciences Innovators Forum) virtual presentation, “COVID-19: Changes In FDA Approval & Clearance Processes.” Read more here.
There is new research out of Iceland that suggests the body’s immune response to COVID-19 lasts longer than other research has suggested. The study, published in the New England Journal of Medicine, described the results of tests on more than 30,000 people in Iceland. It was conducted by Reykjavik-based deCODE Genetics, a subsidiary of U.S.-based Amgen, along with several Icelandic hospitals, universities and health officials.
As reported by The Washington Post, on Tuesday, the Trump administration said it will not work with the World Health Organization in the effort to develop and distribute a COVID-19 vaccine.