Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 7, 2020.
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
FDA Actions
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.
Company Actions/Announcements
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.
