Biopharma Update on the Novel Coronavirus: June 15

CV Update_June 15

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.


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