Biopharma Update on the Novel Coronavirus: September 18
News information is not all-inclusive and updates are published on Mondays, Wednesdays and Fridays.
FDA Actions
Abbreviated New Drug Applications: The FDA has approved abbreviated new drug applications for the following.
- dexmedetomidine hydrochloride in 0.9% sodium chloride injection for the sedation of initially intubated and mechanically ventilated patients and non-intubated patients prior to and/or during surgical and other procedures
- propofol injectable emulsion USP 200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL, for Single Patient Use Only
Diagnostics Update: To-date the FDA has authorized 248 individual EUAs, which include 198 molecular tests, 46 antibody tests and 4 antigen tests.
Diagnostics
Roche launched its Elecsys Anti-SARS-CoV-2 S antibody test for markets that accept the CE Mark. It has also filed with the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA).
As reported by The New York Times, CDC COVID-19 testing recommendations posted last month were not written by CDC scientists and were posted despite their serious objections. The guidance said it was not necessary to test people without symptoms of COVID-19 even if they had been exposed to someone who had tested positive.
Testing Therapies, Antivirals and Vaccines
A rheumatoid arthritis drug developed by Genentech proved to be effective in benefitting patients who have COVID-19-associated pneumonia, according to new late-stage clinical trial data. Important to note is that 85% of participants in the trial were from minority racial and ethnic groups, which are historically underrepresented in clinical studies. Please read more here.
Moderna hosted its 2020 R&D Day to offer a progress report across its portfolio, but the most attention was paid to its update on the COVID-19 vaccine trial. The Phase III COVE trial of the COVID-19 vaccine, mRNA-1273, enrolled 25,296 volunteers as of September 16. To date, 10,025 participants have received the second vaccination. The company also said that it had published its Phase III trial protocol online in order to provide additional transparency.
Cidara Therapeutics is hoping that its novel approach to influenza will prevent future “twindemic” double threats like the one we may face this year. With their proprietary Cloudbreak® antiviral platform, Cidara is developing long-acting therapeutics designed to improve the standard of care for patients with serious fungal or viral infections. Please read more here.
Company Actions/Announcements
In anticipation of data from its Phase III vaccine candidate study potentially becoming available next month, Germany’s BioNTech acquired a manufacturing facility from Novartis to boost production capabilities for the preventative treatment for the novel coronavirus. Please read more here.
Sanofi and GlaxoSmithKline finalized and signed an advanced purchase agreement today with the European Commission for the supply of up to 300 million doses of a COVID-19 vaccine.
Other Industry News
Robert Redfield, director of the U.S. Centers for Disease Control and Prevention (CDC), testified this week before the U.S. Senate Appropriations subcommittee on labor, health and human services, education and related agencies. He noted that although a vaccine against COVID-19 will likely be available and to begin dosing in November or December of this year, it will be limited. Getting the entire U.S. population vaccinated will likely take “six to nine months.”
Hospital for Special Surgery funded nine grants for projects related to the study of COVID-19. Projects include the use of CDK7 inhibitors to target COVID-19–associated cytokine storm and mechanisms of cytokine storm in patients with COVID-19.
COVID-19 didn’t disappear with summer temperatures, it just shifted locations and demographics. Now, with both autumn and flu season fast approaching, nearly everyone is wondering whether we will endure another round of illnesses that will rival that of last spring. Please read more here.