NLS COVID-19

The European Commission (EC) has granted Novavax conditional marketing authorization (CMA) for Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The authorization follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation to authorize the vaccine […]

The Committee for Medicinal Products for Human Use of the EMA has adopted a positive opinion of Kineret for the treatment of COVID-19 in adult patients with pneumonia requiring supplemental oxygen who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor ≥ 6ng/ml. EMA has […]

Cyxone has announced results from a phase 2 study of Rabeximod in Covid-19 patients with moderate disease. The primary endpoint, ultimately proposed by the FDA, was to document the difference of the proportion of subjects alive and free of respiratory failure at day 28 between placebo (standard of care treatment) and Rabeximod plus standard of […]

Evusheld (formerly AZD7442) long-acting antibody combination authorized for emergency use in the US for pre-exposure prophylaxis (prevention) of COVID-19. The Food and Drug Administration (FDA) granted the EUA for Evusheld for pre-exposure prophylaxis of COVID-19 in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune compromise due […]

The last manufacturing steps of the company’s Evusheld (previously AZD7442) will take place in Södertälje, Sweden. Packaging and release of the potential new drug, a combination of long-acting antibodies that both prevent and treat COVID-19, has already begun in Södertälje – AstraZeneca’s largest facility within its global production network. The plan is to increase production […]

EMA’s human medicines committee (CHMP) has issued advice on the use of Merck’s (known as MSD outside the United States and Canada) Lagevrio (also known as molnupiravir or MK 4482) for the treatment of COVID-19. The medicine, which is currently not authorized in the EU, can be used to treat adults with COVID-19 who do […]