Dangerous blood clots and thrombocytopenia, rare simultaneous side effects seen with two adenoviral vector vaccines from Astrazeneca plc and Johnson & Johnson, as well as a worldwide spike in COVID-19 cases and deaths, primarily in India, has set the stage for what could soon become the next big vaccine option, a protein subunit candidate from Gaithersburg, Md.-based Novavax Inc.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 908 Devices, Avisa, Flurotest, Ivenix, Ivwatch, Moleculight, Premier, Sentinel Diagnostics, Smiths Medical, Vizient.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Carmot, Clarity, Eli Lilly, Hutchmed, Immunomet, Newron, Pfizer, Quercis, R-Pharm Germany, Siga Technologies, Viiv Healthcare.
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.