Infectious Disease

FDA gives expanded EUA for Pfizer-BioNTech Covid-19 vaccine booster dose

The US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech Covid-19 vaccine.

Enzolytics, Samsung Biologics partner to develop therapies for HIV, Covid-19

Samsung Biologics and Enzolytics have entered a strategic contract development and manufacturing organization (CDMO) collaboration agreement to develop and produce monoclonal antibody treatments for human immunodeficiency virus (HIV) and Covid-19.

AstraZeneca seeks FDA EUA for antibody cocktail to prevent Covid-19

AstraZeneca has sought Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its AZD7442 to prevent symptomatic Covid-19.

Australia signs agreement for new Covid-19 drug

Australia has signed an agreement for 300,000 courses of molnupiravir, an antiviral pill that has shown signs of reducing deaths and hospitalisations due to Covid-19.

Trevena reports positive results of TRV027 proof-of-concept trial in Covid-19 patients

Trevena has announced positive results from a proof-of-concept clinical trial during which its new AT1 receptor-selective agonist, TRV027, was found to be well-tolerated in Covid-19 patients who have been hospitalised. 

Pfizer-BioNTech reports positive results for Covid-19 vaccine trail in children aged 5 to 11 years

Pfizer and its partner BioNTech have announced positive topline results from a pivotal trial of their Covid-19 vaccine in children aged 5 to 11 years.

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.