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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carthera, Medtronic, Nucleix, Oxfordvr, Pictor.
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.
Medical device supply chain considerations became especially salient during the COVID-19 pandemic, but the U.S. FDA is interested in ensuring that supply chains do not hamper patient access going forward. However, Clayton Hall of the Medical Device Manufacturers Association (MDMA) said on a recent FDA webinar that device makers are sometimes at the mercy of their suppliers.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Acepodia, BMS, Eli Lilly, Hepion, Moderna.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ABVC, Affinivax, Amniotics, Anixa, Ashvattha, Emercell, Kinarus, Onward.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AOP, Edgewise, Engrail, Kinarus, Pharmaessentia, Ultimovacs, Xbiotech.
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