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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advent, Astria, Biophytis, Excision, Hutchmed, Ipsen, Junshi, Pharmala.
A day after a U.S. House committee, on a party-line vote, advanced two bills to reauthorize emergency preparedness programs, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 17-3 July 20 to send its bipartisan reauthorization of the Pandemic and All Hazards Preparedness Act to the Senate floor with a do-pass recommendation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Cel-Sci, Emmaus, Gilead, Scisparc.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arrivent, Bluebird, Coherus, Crispr, Frequency Therapeutics, Innocare, Korro Bio, KSQ, Nymox, Roche, Superior Biologics, Vertex.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biosenic, BMC, Camp4, Elsie, FSD, Fulcrum, Genethon, GSK, Hillstream, Innovent, Maxcyte, Melinta, Novartis, Novavax, Novo Nordisk, Nymox, Paratek, Remegen, Vittoria.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Iaso, Mediwound, Moderna, Nevakar, Injectables, Skyline, Systimmune, Zealand.
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