Biopharma Update on the Novel Coronavirus: August 17
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
Device Shortage List: The FDA is providing a device shortage list during the COVID-19 pandemic.
EUA: The FDA issued a EUA for Baxter Healthcare Corporation’s REGIOCIT for adult patients being treated with continuous renal replacement therapy (CRRT).
EUA: The FDA issued a EUA to Yale School of Public Health for a new method of processing saliva samples when testing for COVID-19. The diagnostic test is called SalivaDirect.
Diagnostics Update: To-date the FDA has authorized 213 individual EUAs, which include 174 molecular tests, 37 antibody tests and 2 antigen tests.
The FDA issued a EUA to Yale School of Public Health for a new method of processing saliva samples when testing for COVID-19. The diagnostic test is called SalivaDirect. SalivaDirect is less invasive and less expensive than other forms of testing and results so far have found the test to be highly sensitive.
Testing Therapies, Antivirals and Vaccines
OSE Immunotherapeutics published positive data from preclinical and human ex vivo studies with CoVepiT, its prophylactic vaccine against COVID-19. The vaccine appears to provide strong memory T-cell responses after a single shot.
CanSino Biologics has started a late-stage trial of a COVID-19 vaccine candidate in Russia.
As several vaccines against COVID-19 speed their way through Phase III clinical trials, the companies and partners have been focusing on scaling up manufacturing “at risk,” meaning they’re making the vaccines without knowing if they are safe enough and effective enough for approval. The plan is that when and if they are approved, they will be ready and available for distribution. Another component of that plan fell into place with the selection of McKesson Corp. to help distribute the vaccines under Operation Warp Speed on Friday.
As reported by the Financial Times, CureVac has said they will not be selling their COVID-19 vaccine at cost, but indicating the price would be at an “ethical margin”.
Illumina Cambridge is suing BGI subsidiaries over patent infringement.
HiFiBiO Therapeutics announced a collaboration with Coronavirus Immunotherapy Consortium (CoVIC), a non-profit research alliance at the La Jolla Institute for Immunology. HiFiBiO has developed multiple SARS-CoV-2 neutralizing antibodies that could address both therapeutic and prophylactic applications.
Other Industry News
Researchers studying wastewater samples are finding traces of SARS-CoV-2 in samples taken much earlier than the virus first appeared in China. It was found as early as March 2019 in Barcelona, for example, which would be almost nine months before it was first observed in China. This has led some epidemiologists to suggest the virus did not originate in China and may have been more widely present in the environment.
In the midst of an international pandemic, three high-profile public health officials are leaving government service.