Roche’s Genentech has announced that its intravenous Actemra (tocilizumab) has received emergency use authorisation from the US Food and Drug Administration for treating hospitalised Covid-19 patients. Actemra can be administered to adults as well as children aged two years and older, who maybe receiving systemic corticosteroids, require ventilation, oxygen, or extracorporeal membrane oxygenation. The authorisation is based on results from four randomised, controlled studies that assessed Actemra’s efficacy in treating Covid-19 in more than 5,500 hospitalised patients.
The Drugs Controller General of India has allowed pharmaceutical company PNB Vesper to conduct a Phase III clinical trial of its PNB 001/GPP-BALACOVIN Covid-19 drug. After receiving top line results from the Phase II clinical trial, the company is now advancing towards a nationwide, multi-centre, Phase III trial for treating hospitalised Covid-19 patients who require oxygen support. The Phase III trial will be held among a large patient population across 12 hospitals in India.
Thailand’s food and drug administration announced has approved the Pfizer-BioNTech Covid-19 vaccine for emergency use. Senior health officials state that this is the sixth coronavirus vaccine to be approved in the country. Thailand has ordered approximately 20 million doses of the Pfizer-BioNTech vaccine and expects to receive them by the end of 2021.