Biopharma Update on the Novel Coronavirus: June 29
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
Warning Letter: The FDA issued a warning letter to Curativa Bay Corporation for selling fraudulent COVID-19 products.
Updated Templates: The FDA issued updated templates to help facilitate the submission of EUAs for serology tests.
Diagnostics Update: To-date the FDA has authorized153 individual EUAs, which include 129 molecular tests, 23 antibody tests and 1 antigen test.
Beckman Coulter announced the FDA has issued a EUA for its SARS-CoV-2 IgG antibody test. The company will be able to deliver more than 30 million tests per month.
Testing Therapies, Antivirals and Vaccines
Altimmune received $4.7 million from the U.S. Army Medical Research & Development Command (USAMRDC) to fund its Phase I/II clinical trial of T-COVID, an investigational intranasal immune modulator for treatment of outpatients with early COVID-19. It was granted by USAMRDC in collaboration with the Medical Technology Enterprise Consortium (MTEC). The trial is expected to start in the coming weeks with a data readout in the fourth quarter of 2020.
Gilead Sciences set the price of the only approved treatment for COVID-19, remdesivir, at $390 per vial, which for most patients receiving a 5-day treatment using six vials, would come to $2,340 per patient.
As reported by Reuters, Temasek, a Singapore wealth fund and others are investing $250 million into BioNTech, which is developing a COVID-19 vaccine with Pfizer.
Fluidigm Corporation announced that its Fluidigm mass cytometry technology and the Maxpar Direct Immune Profiling Assay was being used in a prospective observational cohort surveillance study of up to 2,000 adults hospitalized with COVID-19.
Todos Medical entered into a partnership with Meridian Health services network to deploy COVID-19 testing programs throughout the U.S. Todos will help supplement COVID-19 testing products and services for its network of brick-and-mortar and mobile laboratories nationwide.
CytoDyn entered into a Memorandum of Understanding (MOU) with the Coordinating Commission of the National Institutes of Health and High Specialty Hospitals of Mexico to conduct a clinical trial using leronlimab in severe and critically ill COVID-19 patients. There is also the potential to collaboration on more COVID-19 trials.
Other Industry News
Gargling salt water is a time-tested way to alleviate sore-throat pain. As a nasal lavage, it can help clear stuffy sinuses associated with colds and allergies. But, is it effective against the symptoms of COVID-19? Researchers in Scotland aim to find out.