Brazilian health care regulator Anvisa has issued guidelines for SARS-CoV-2 vaccine manufacturers to receive emergency marketing approvals in the Latin American giant. Brazil is the largest market in the region and several COVID-19 vaccine makers are both doing trials there and hoping for quick approvals.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, Alzecure, Antengene, Artiva, Chimerix, Immunicum, Kronos, Lipocine, Neuren, Novo Nordisk, Scpharmaceuticals, Scynexis, Sol-Gel, Viracta, Yiling.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA, industry prepare for vaccine; FDA updates trial guidance; Labeling changes for diabetes drugs.
Harvard University’s Wyss Institute for Biologically Inspired Engineering licensed its Erapid electrochemical sensing platform to IQ Group Global to integrate with the Australian consortium’s transistor technology in a SARS-CoV-2 test. The combined solution could greatly simplify serological testing for the virus and help monitor immunity in individuals and populations over time.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avinger, Australian Biotechnologies, Elixirgen, Flowmetric, Onegevity, RenalytixAI, Ricoh, Sherlock Biosciences, Shockwave Medical, Spartech, The Commons Project, Theracell, Tolo Biotech, Tufpak.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Apeiron, Ascletis, Clover, Cortexyme, Precision, Takeda, Sutro.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Caretaker Medical, Viveve.
Shares of immunotherapy developer Enlivex Therapeutics Ltd. (NASDAQ:ENLV) climbed as much as 69% Dec. 3 after interim data showed the apparent benefits of its lead candidate, Allocetra, for severe and critical COVID-19 patients.
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