Biopharma Update on the Novel Coronavirus: August 7
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
Warning Letters: The FDA issued a warning letter to New Life International and second warning letter to Fishman Chemical of North Carolina, LLC for distribution of chloroquine phosphate products with concern that consumers may make a mistake that the products are for humans.
EUAs: The FDA issued the following EUAs.
- Subsalve Oxygen Treatment Hood (Lombardi Undersea)
- VORTRAN GO2VENT with PEEP Valve (VORTRAN Medical Technology 1, Inc.)
- nHale (Nanotronics Imaging, Inc.)
Diagnostics Update: To-date the FDA has authorized 204 individual EUAs, which include 167 molecular tests, 35 antibody tests and 2 antigen tests.
Testing Therapies, Antivirals and Vaccines
Intravenous immunoglobulin (IVIG) could be a key to combating seriously ill COVID-19 patients who have been hospitalized due to complications from the disease, and Octapharma AG aims to find out as it assesses the plasma-based treatment in a Phase III study.
Days after Novavax, Inc. announced its experimental COVID-19 vaccine candidate produced antibodies in healthy patients in a clinical study, the company announced a license agreement with Serum Institute of India Private Limited (SIPL) to develop up to 1 billion doses of the preventative drug in India and other countries.
Additionally, Novavax signed a deal with Takeda Pharmaceutical to manufacture and distribute its experimental COVID-19 vaccine, NVX‑CoV2373 in Japan. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year.
AstraZeneca signed a deal with Beijing-based Shenzhen Kangtai Biological Products to manufacture AstraZeneca and the University of Oxford’s COVID-19 vaccine in mainland China.
Gilead Sciences announced it has increased manufacturing capabilities for its antiviral drug, remdesivir to meet real-time global demand starting in October.
Pfizer announced a multi-year agreement with Gilead Sciences. Under the agreement, Pfizer will provide contract manufacturing services to manufacture and supply remdesivir for Gilead. The agreement will help support efforts to help scale up the supply of remdesivir as an investigational treatment for COVID-19.
Other Industry News
Although obesity is a known risk factor for death from many conditions, such as cardiovascular disease, experts are now wondering how COVID-19 may impact those who fall into this category. Scientists are already aware that vaccines designed to protect people from conditions, such as hepatitis B, are less effective in obese adults, according to CNN. Now, researchers say there is little reason to believe that a COVID-19 vaccine would be any different.
As reported by CNN, researchers in Hong Kong reported that COVID-19 may suppress the function of key immune cells which prevents the body from fighting the infection.
U.K.-based Avacta Group entered into a collaboration with the Liverpool School of Tropical Medicine to clinically validate the rapid, saliva-based coronavirus antigen test that Avacta is developing with Cytiva.
As part of Operation Ward Speed, Grand River Aseptic Manufacturing (GRAM), has been selected by the U.S. Department of Health and Human Services and the U.S. Department of Defense to expand the United States’ capacity for manufacturing and distributing vaccines or therapeutics related to the COVID-19 pandemic. This announcement comes on the heels of the grand opening of GRAM’s newest manufacturing facility, a 60,000 sq. ft., large-scale fill/finish facility located in downtown Grand Rapids, Michigan.