Infectious Disease

US FDA declines Humanigen’s request for EUA for Covid-19 antibody lenzilumab

The US Food and Drug Administration (FDA) has declined Humanigen’s request for Emergency Use Authorization (EUA) of its antibody lenzilumab to treat newly hospitalised Covid-19 patients. 

AIM submits Pre-IND application to study Ampligen for Covid-19

AIM ImmunoTech has submitted a pre-investigational new drug (Pre-IND) application to the US Food and Drug Administration (FDA) for a study of Ampligen as a potential infusion treatment for post-Covid-19 cognitive dysfunction (PCCD).

India’s Reliance secures DCGI nod to carry out Phase I Covid-19 vaccine trial

The Drugs Controller General of India (DCGI) has given approval to Reliance Life Sciences to conduct a Phase I clinical trial of its Covid-19 vaccine with certain conditions.

Senhwa secures DMC approval to advance Phase II trial of Silmitasertib

Senhwa Biosciences has announced that its oral drug, Silmitasertib, has received positive feedback from an independent Data Monitoring Committee (DMC) in an interim review of Phase II investigator-initiated trial in patients with severe Covid-19.

Moderna’s Covid-19 vaccine found to maintain antibodies against variants of concern to 6 months

Moderna has announced that in a new study its Covid-19 messenger ribonucleic acid (mRNA) vaccine showed durable efficacy in generating neutralising antibodies against SARS-CoV-2 variants of concern.

Inovio secures approval to begin Covid-19 vaccine prime-boost trials in China

Inovio has secured approval from Center for Drug Evaluation of the National Medical Products Administration in China to carry out two clinical trials of heterologous prime-boosting with its Covid-19 vaccine candidate, INO-4800.

India approves J&J’s single-dose Covid-19 vaccine for emergency use

India has given approval to Johnson & Johnson’s (J&J) single-dose Covid-19 vaccine for emergency use.

Akston commences dosing in Phase II trial of Covid-19 vaccine

Akston Biosciences has initiated dosing of the first subjects in a Phase II open-label trial of AKS-452, its protein subunit Covid-19 vaccine candidate.

NIH study completes subject enrolment for Brii Biosciences’ Covid-19 antibodies

Brii Biosciences has announced that ACTIV-2 clinical trial of the National Institutes of Health (NIH) in the US closed enrolment for the Phase III part that will evaluate BRII-196 plus BRII-198 for Covid-19 treatment.