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June 9, 2020

Coronavirus company news summary – EMA to conduct expedited review of remdesivir – India’s BSVL to conduct Phase III trial of sepsis drug

By Allie Nawrat

9 June 2020 

The European Medicines Agency (EMA) is set to review under a reduced timeline Gilead Sciences’ application for conditional marketing authorisation (CMA) of remdesivir to treat Covid-19. This short timeframe is said to be possible as the agency had already reviewed some data during the first cycle of the rolling review.

Japan-based Daiichi Sankyo has signed a basic agreement with the University of Tokyo, Nichi-Iko Pharmaceutical and RIKEN for the research and development of an inhalation formulation of Nafamostat to treat Covid-19. Nafamostat is an injectable therapy indicated in Japan to treat acute pancreatitis and disseminated intravascular coagulation.

India-based Bharat Serums and Vaccines (BSVL) has secured regulatory approval to assess its sepsis drug, Ulinastatin, in Phase III clinical trial to treat Covid-19. The trial, set to commence soon, will involve approximately 120 patients with mild to moderate symptoms of acute respiratory distress syndrome (ARDS).

SiO2 Materials Science has secured $143m contract from U.S. Government to speed-up the production scale-up of its primary packaging platform to store Covid-19 vaccines and therapeutics. SiO2’s product comprises a plastic container with a microscopic glass coating for biological drugs and vaccines.

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