Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Asklepios, Bayer, Imunon and Lumicell.
In a study from the PHOSP-COVID and ISARIC-4C consortia in the U.K., researchers have discovered inflammatory processes taking place during what is termed “long COVID.” Long COVID is defined by the World Health Organization (WHO) as the continuation or development of new symptoms for 3 or more months after the initial SARS-CoV-2 infection. It is estimated that 1 in 10 SARS-CoV-2 infections results in long COVID, thus affecting about 65 million people worldwide.
SARS-CoV-2 could proliferate in the lungs causing severe COVID-19 through a special type of immune cell. A group of scientists from Stanford University observed how this coronavirus infected interstitial macrophages through a CD209 receptor, triggering the inflammatory response observed in hospitalized patients.
Blackstone Life Sciences made an investment of up to $750 million in Moderna Inc.’s influenza program created with its mRNA technology. The new funding is designed to help propel the program forward and may help bolster a stock that has struggled in the past 12 months.
The U.S. FDA granted emergency use authorization (EUA) on March 22 for Waltham, Mass.-based Invivyd Inc.’s half-life extended monoclonal antibody (MAb) VYD-222 – making it available to prevent COVID-19 in immunocompromised adults and adolescents – but its use comes with a boxed warning for anaphylaxis.
Merck & Co. has revealed the discovery of novel oral SARS-CoV-2 3C-like proteinase (3CLpro; Mpro) inhibitors for the potential treatment and/or prophylaxis of COVID-19. 3CLpro plays a key role in viral life cycle by cleaving viral protein and helps in replication and infection, which make 3CLpro a target for designing drugs to treat COVID-19.
Hyundai Bioscience Corp. is set to become the largest shareholder of ADM Korea Inc., a Seoul, South Korea-based contract research organization (CRO) firm, by purchasing 5.02 million shares for ₩20.4 billion (US$15.5 million) – a 23% stake.
Hyundai Bioscience Corp. is set to become the largest shareholder of ADM Korea Inc., a Seoul, South Korea-based contract research organization (CRO) firm, by purchasing 5.02 million shares for ₩20.4 billion (US$15.5 million) – a 23% stake.
Shionogi & Co. Ltd., of Osaka, Japan, gained standard approval from Japan’s Ministry of Health, Labour and Welfare for Xocova (ensitrelvir fumaric acid) on March 5, making it the first COVID-19 antiviral to win full approval in the country.