Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 15, 2020.
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
FDA Actions
Warning Letter
:
The FDA issued a warning letter to
EUCYT Laboratories, LLC
, for marketing an unapproved product for the treatment or prevention of COVID-19.
Diagnostics Update
:
The FDA has worked with more than 400 test developers who have submitted or plan to submit EUA requests to detect COVID-19. Also, 135 individual EUAs have been issued, which include 114 molecular tests, 20 antibody tests and 1 antigen test.
Testing Therapies, Antivirals and Vaccines
Eli Lilly and Company
reported
it had enrolled the first patient in its Phase III trial of baricitinib in hospitalized adults with COVID-19. The drug is marketed as Olumiant for adults with moderately to severely active rheumatoid arthritis (RA).
Eli Lilly
will assess
its JAK1/JAK2 inhibitor Olumiant (baricitinib) as a potential treatment for COVID-19 in a Phase III study.
Beijing-based
Sinovac Biotech
announced
positive early data from a Phase I/II clinical trial of its COVID-19 vaccine, CoronaVac. The vaccine showed both favorable immunogenicity and safety.
Health Canada gave
expedited approval
to
Edesa Biotech
to begin a Phase II/III clinical trial of a potential COVID-19 treatment for its investigational drug, EB05.
Data from a
Mayo Clinic
-sponsored study of
Humanigen Inc
’s lenzilumab in COVID-19 patients are bearing fruit. Data shows that patients demonstrated rapid clinical improvement with a median time to recovery of five days, median time to discharge of five days and 100% survival to the data cut-off date. Patients also demonstrated rapid improvement in oxygenation, temperature, inflammatory cytokines and key hematological parameters consistent with improved clinical outcomes.
aTyr Pharma
dosed the first patient
in its Phase II trial of ATYR1923 in COVID-19 patients with severe respiratory complications. TYR1923 is a potential first-in-class immunomodulator.
Beyond Air
enrolled
the first patient in the US trial of LungFit to treat COVID-19 with nitric oxide (NO) therapy. The patient was enrolled at the Baptist Health Center for Clinical Research in Little Rock, Arkansas.
Company Actions
As
AstraZeneca
closes in on developing a vaccine against COVID-19, the U.K. pharma giant
struck a deal
with Europe’s Inclusive Vaccines Alliance to supply up to 400 million doses of the preventative medication by the end of 2020 – if it clears the clinic.
Dr. Reddy’s Laboratories
announced
it has entered into a non-exclusive licensing agreement with
Gilead Sciences
to register, manufacture and sell remdesivir for COVID-19 in 127 countries.
Vaxart, Inc.
appointed
a new CEO, Andrei Floroiu, to accelerate the advancement of COVID-19 and other programs.
Other Industry News
On Monday, it was
announced
that Germany will take a 23% stake in biotech firm
CureVac
. CureVac is currently working on a COVID-19 vaccine.
As
reported
by the
Wall Street Journal
, new research, found that infection with other coronaviruses such as severe respiratory syndrome, SARS and even the common cold may help the body to fight off COVID-19.
As
reported
by
Reuters
, a new study finds that people who take popular blood pressure medicines are not at greater risk for COVID-19, as previously feared.
Researchers at
Stony Brook University
led by
Liliana Davalos
, Department of Ecology and Evolution, will
study
how viruses affect cells upon entry into the bat host in the nasal passages. They believe this research might help understand why symptomatic disease does not occur in bats, which could lead to approaches to protect against future coronavirus outbreaks in humans.
