Before formally introducing legislation to spur R&D of treatments for long COVID, the U.S. Senate Health, Education, Labor and Pensions Committee is calling for stakeholder input on the proposal that would require $10 billion in dedicated, mandatory NIH funding to respond to the chronic condition over the next 10 years.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Advicenne, Astrazeneca, Bluejay, Daiichi Sankyo, Esperion, Invivyd, Regeneron, Tonix.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apogee, Astria, Axsome, Beyondspring, Cassava, Invivyd, Matinas, Syros.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boehringer Ingelheim, Cocrystal, Cosmo, CSL Vifor, Deverra, Forge, Hasten, Lib, Orchard, PTC, Revive.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzprotect, Astrocyte, Bavarian Nordic, Clearmind, Cybin, Imunon, Innocare, Pacira, Pepgen, Pfizer, Prilenia, Psyence, Puretech.
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.