8 February 2021
Celltrion Group announced that South Korea’s Ministry of Food and Drug Safety has granted a conditional marketing authorisation to the company’s Regdanvimab (CT-P59). The anti-Covid-19 monoclonal antibody drug has been allowed for emergency use among patients aged 60 years and above, or people suffering with at least one underlying comorbidity along with mild Covid-19 symptoms, and among adult patients suffering from moderate symptoms.
Bukwang Pharmaceutical announced that the US Food and Drug Administration (FDA) has granted the company an investigational new drug (IND) application to conduct a Phase II clinical trial of Levovir to fight Covid-19. The trial is expected to be conducted in a multi-centre randomised double-blind placebo-controlled trial for outpatients. It will test the efficacy and safety of the drug or placebo among 40 patients, excluding those suffering from serious Covid-19 symptoms.
A letter from the food and drug agency in Indonesia stated that the country has approved Sinovac Biotech’s Covid-19 vaccine for use in its elderly population. This is expected to potentially change the country’s vaccination strategy, which had earlier prioritised the vaccination of its working population.
The Russian Direct Investment Fund announced that the Russian Sputnik V vaccine for Covid-19 had been registered for emergency use in Myanmar. The vaccine recived approval without the need to conduct additional clinical trials in the country. This makes Myanmar the 21st country in the world to approve the Sputnik V vaccine.