Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alterity, Amryt, Astrazeneca, Biontech, CNS, Fusion, Menarini, Merck & Co., Novartis, Novavax, Radius, Realta, Rockwell, Valneva.
While the biopharma industry was widely praised for its fast response to the COVID-19 pandemic, moves are afoot to ensure that the world is better prepared in case another pandemic hits. Moderna Inc. was one of the companies that blazed a trail in the early stages of the pandemic with its revolutionary mRNA vaccine. Now the firm is investing in manufacturing and R&D in the U.K. to make good on a pledge to respond to the next global disease threat within 100 days of its detection.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cortexyme, Kiromic, Halberd, SQZ, Surface, Tonix.
While the World Trade Organization (WTO) is taking a victory lap for getting a five-year intellectual property (IP) waiver across the finish line for COVID-19 vaccines, the accomplishment is being panned by spectators on both sides of the track.
Afrigen Biologics (Pty) Ltd. is teaming up with two Belgian firms to co-develop and produce an mRNA-based COVID-19 vaccine intended for distribution throughout Africa. It’s an open question whether the vaccine will actually contribute to the present pandemic response, given the timelines involved in both validating the production facility that will produce the end product and in running the necessary trials in order to gain approval.