Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arch, Biolinerx, Checkmate, Cytokinetics, Cyxone, Genprex, HDT Bio, Ichnos, Immunitybio, Kiniksa, Merus, Obseva, Revolo, Rezolute, Tarsus, Vaxart, Verona.
HONG KONG – Celltrion Inc. has received the European CE mark for Tekitrust, its COVID-19 tests kit developed with Mico Biomed Co. Ltd. “Mico, which is a diagnostic device specialist, partnered with Celltrion to combine both companies’ strengths in the test kit sector,” a Celltrion spokesperson told BioWorld. Mico will manufacture the kits, while Celltrion handles marketing and sales.
LONDON – A single dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine does not promote a strong enough immune response to provide protection against variants of SARS-CoV-2, including the Kent variant B.1.1.7, which as of April 29 had caused 226,635 confirmed infections in the U.K.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Canon Medical Systems USA, Closedloop.ai, Cradle Genomics, Echelon Diagnostics, Ocular Therapeutix, Precipio, Raysearch Laboratories.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advicenne, Amicus, Avrobio, Astrazeneca, Camurus, Chiesi, Clearside, Galmed, Intra-Cellular, Jacobio, Moderna.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Actuate, Biovaxys, Cocrystal, Enteris, Esteve, Gain, Gemini, Gensight, Hoth, Immunicum, J&J, Kowa, Lantern, Moderna, Moonlake, Merck KGaA, New Life, Ocugen, Revive, Samsung Bioepis, Sonnet, Tryp, Xoma.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arup Laboratories, Conventus-Flower, Cynosure, Evon Medics, Genome Medical, Midiagnostics, Myellevate, Patientsafe Solutions, Red One Medical, Specific Diagnostics, Techcyte, Vocera.
Vaccitech plc and Werewolf Therapeutics Inc. opened the last day of April with contrasting IPOs. Both priced mid-range, with Vaccitech raising $110.5 million, similar to Werewolf's $120 million haul. However, American depository shares of Vaccitech (NASDAQ:VACC), co-developer of Astrazeneca plc’s COVID-19 vaccine, fell 17.1% to $14.10 from a $17 open, while shares of cancer therapy developer Werewolf (NASDAQ:HOWL) boomed – until they didn't – climbing to $24 before closing about where they started, at $16.10.
Emergent Biosolutions Inc. CEO Robert Kramer assured investors that he takes “full responsibility” for woes that beset the firm after the FDA’s Form 483 found serious manufacturing problems at the Baltimore, Md.-based Bayview plant. “You have my commitment that we're going to do everything we can to resolve these issues quickly, and as safely as possible,” he said during an April 29 conference call on first-quarter financial results.
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