Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Futura, Georgiamune, Lemonex, Precigen, Virios.
Novavax Inc. has signed off 6.5 million shares to SK Bioscience Co. Ltd. for an $85 million equity investment from the South Korean pharmaceutical firm, which also wrote off some of Novavax’s manufacturing liabilities, as part of their continuing vaccine alliance. Seongnam-si, South Korea-based SK Bioscience purchased Novavax shares at $13 each, reflecting a 59% premium over the 90-day trading value, to gain a 6.45% stake in the Gaithersburg, Md.-based mRNA vaccine company, an SK Bioscience spokesperson confirmed to BioWorld.
Building on capabilities developed during the COVID-19 pandemic, the U.K. Health Security Agency’s Vaccine Development and Evaluation Centre hit the ground running.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aiviva, Apogee, Bavarian Nordic, Halia, Humanigen, Nektar, Passage, Praxis, Tonix, Vistagen.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hipra, M8, Molecular Targeting, Satellos.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cybin, Enlivex, Ideaya, Immunis, India Globalization, Inimmune, Oculis, Theriva.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bridgebio, Biohaven, Citius, GC, Harm Reduction, Invectys, Marinus, Merck & Co., Moberg, Nanjing Leads, Redhill, Spero, Transcenta.
Clinical data in the first half of 2023 is up 1.51% compared to the same time period last year. So far in 2023 BioWorld reported on 1,810 drugs in phase I-III, compared to 1,783 in the first half of 2022. The number of trial updates is down 13.6% from the 2,095 in 2021, but more than 2020’s 1,799 and 2019’s 1,477.
Taking strides from its start as a Seoul National University laboratory, South Korea’s Cellid Co. Ltd. said July 24 that the MFDS approved an IND for the global phase III trial for its omicron variant-targeting COVID-19 vaccine called AdCLD-CoV19-1 OMI. Approval from the MFDS comes two months after Cellid filed the IND on May 23 for its adenovirus vector platform vaccine “capable of responding quickly to virus mutations,” the company said.
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