US-based Emergent BioSolutions has announced the start of the Phase III INSIGHT-013 trial to analyse its plasma-derived therapy, COVID-19 Human Immune Globulin (COVID-HIG), in hospitalised patients with Covid-19. The trial, funded by the US National Institute of Allergy and Infectious Diseases, will test the safety, tolerability and efficacy of hyperimmune intravenous immunoglobulin products. As well as COVID-HIG, the Phase III trial will assess hyperimmune globulin products by Takeda Pharmaceuticals, Grifols and CSL Behring.
The European Commission (EC) has approved an advance purchase agreement by Johnson & Johnson for Janssen Pharmaceutical to supply 200 million doses of its Covid-19 vaccine candidate to EU member states upon approval or authorisation. The countries will have an option for up to 200 million additional doses. J&J also intends to allocate up to 500 million doses toward global efforts to supply low-income countries.
Gilead Sciences has reported final results from the Phase III ACTT-1 clinical trial, where its experimental antiviral Veklury (remdesivir) demonstrated consistent, clinically meaningful improvements when compared to placebo, in hospitalised adults with mild-moderate or severe Covid-19. Data showed that treatment with the drug led to a faster time to recovery.
Rentschler Biopharma has agreed to act as contract development and manufacturing organisation partner to support drug substance manufacturing of BNT162b2, the Covid-19 vaccine candidate being developed by Pfizer and BioNTech. Rentschler will carry out downstream processing to deliver purified drug substance by removing process and product-related impurities. The purified drug substance will be generated at Rentschler’s headquarters in Laupheim, Germany.
Eli Lilly has signed an agreement with the Bill & Melinda Gates Foundation to enable access by low- and middle-income countries to its future therapeutic antibodies, being developed to prevent and treat Covid-19. The deal, part of the COVID-19 Therapeutics Accelerator, will see the start of commercial manufacturing in April next year. In addition, Lilly reported that its drug baricitinib plus Gilead’s remdesivir decreased time to recovery and improved clinical outcomes in Covid-19 patients, compared to remdesivir alone.
China has joined the COVAX initiative, which is co-led by the World Health Organization (WHO) to ensure equitable distribution of Covid-19 vaccines globally. The COVAX initiative aims to provide at least two billion vaccine doses by the end of 2021. China joins 168 countries that have committed to participate in the vaccine initiative. The US and Russia have not joined the programme thus far.
Russia-based R-Pharm is assessing rheumatoid arthritis drug olokizumab for the treatment of patients suffering from moderate to severe Covid-19, according to Reuters. Final data from a placebo-controlled, randomised trial in 372 participants is expected to be published late this month or early next month. The drug has been included in national guidelines for treating patients with moderate Covid-19, the news agency added.