Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Futura, Georgiamune, Lemonex, Precigen, Virios.
Lemonex Inc. announced that the IND application for its mRNA vaccine candidate LEM-mR203 has been approved by the Korean Ministry of Food and Drug Safety (MFDS) on July 21, 2023. The company plans to evaluate LEM-mR203 as potential treatment for COVID-19, with the planned phase I clinical trial being designed to assess its safety and immunogenicity in healthy adults at Seoul National University Hospital, Korea.
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.
Simcere Zaiming Pharmaceutical Co. Ltd. has divulged 3C-like proteinase (3CLpro) (SARS-CoV-2) inhibitors reported to be useful for the treatment of respiratory tract infections.
Researchers from Infex Therapeutics Ltd. have announced the nomination of a clinical candidate for its in-house developed COV-X program. The novel first-in-class small molecule is an oral pan-coronavirus papain-like protease (PLpro) inhibitor, which was selected based on preclinical data that demonstrated in vivo efficacy of the candidate a murine model of SARS-CoV-2.
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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Angiodynamics, Body Vision, Cue, Femasys, Hemosonics, Invo, Kral Medical, Prism Technologies, Paragon Care, Shockwave Medical, Tandem.
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