The U.S. Department of Justice and the Securities and Exchange Commission have separately indicted Marc Schessel and his company, Scworx Corp., for making false statements about the company’s ability to provide rapid tests for the COVID-19 pandemic. The indictments include allegations that Schessel and his company had been advised that the tests they had intended to procure were no longer available for distribution in the U.S., but that the Schessel did not advise shareholders of this fact for another 11 days.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Achieve, Alpine, Aruna, Asher, Astellas, Cocrystal, Coda, GSK, ICER, Merck, Neuexcell, Orphazyme, Scineuro, Theolytics and Virios.
About 56% of the clinical data recorded by BioWorld in 2022 target therapies for oncology, as well as infectious and neurological diseases, but news on COVID-19 efforts continue to dwindle compared with last year.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Almirall, Altesa, Amneal, Eisai, Instil, Revive.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agenus, Bavarian Nordic, Blade, Blue Water, Champions, Checkmate, Cyclica, Denali, Fibrobiologics, Immedica, Immunogenesis, Moderna, NRG, Orphanpacific, Oxford Biotherapeutics, Pharmenable, Regeneron, Relief, Revive, Takeda, Targovax, Transcenta, University of Oxford.
Lumiradx Ltd. has secured CE marking for its HbA1c test for diabetes. The point-of-care (POC), automated fingerstick assay is run on the Lumiradx portable platform and designed to provide connected results in under seven minutes, with a reportable range of 20-130 mmol/mol HbA1c (4.0% to 14.0% HbA1c).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avadel, Biomind, Clearmind, Cynata, Hyundai, Innocare, Janssen, Merck, Pfizer, Reata, Revive, Roche, Scisparc, Servier.