Biopharma Update on the Novel Coronavirus: July 3
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
The FDA issued the following EUAs:
- COVID-19 RT-PCR Peptide Nucleic Acid (PNA)
- Kroger Health COVID-19 Test Home Collection Kit,
- Psoma COVID-19 RT Test
Warning Letter: The FDA and FTC issued a warning letter to the Center for Wellness and Integrated Medicine for selling fraudulent COVID-19 products.
Diagnostics Update: To-date the FDA has authorized161 individual EUAs, which include 135 molecular tests, 25 antibody tests and 1 antigen test.
Testing Therapies, Antivirals and Vaccines
As reported by Stat News, Moderna’s COVID-19 vaccine trial has been delayed. The 30,000-patient Phase III trial was expected to start next week, but the expected start date has been pushed back according to investigators.
As reported by Reuters, the University of Oxford’s experimental COVID-19 vaccine indicated the team has seen the right sort of immune response, but are being cautious on the development timeline.
Abivax announced it has treated its first patient in its Phase IIb/III study of ABX464. ABX464 is currently being studied for early treatment of COVID-19.
PrecisionLife announced it has identified 68 genes associated with high risk of severe COVID. This finding suggests new opportunities for new treatment options.
Golden Biotechnology announced the FDA approved its investigational new drug (IND) application for a Phase II clinical trial of Antroquinonol (Hocena®) for a potential treatment of COVID-19 patients with mild-to-moderate pneumonia.
Tesla, the electric car company founded and run by Elon Musk, is building mobile molecular printers to assist Germany’s CureVac in manufacturing its experimental COVID-19 vaccine. Musk tweeted the information on Wednesday, July 1.
Other Industry News
Moderna has always been an odd and secretive company. Currently, all eyes are on the company because it is the furthest along in developing a vaccine against COVID-19. Company shares have rocketed 200% this year. But it’s worth noting it’s a company that does not have a single marketed product.