Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Denali, Minervax, Ortho Regenerative, Recursion, Y-Mabs.
PERTH, Australia – Molecular diagnostic company Speedx Pty Ltd. has invested in a Perth-based startup that makes the raw materials needed for polymerase chain reaction (PCR) COVID-19 tests. The two companies will work to develop a new at-home rapid PCR test to ensure Australia can become self-sufficient with producing PCR tests. A rapid PCR test that gives an accurate result in minutes could be used at home or work.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Perkinelmer, Venclose.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aspira Women’s Health, Capnostics, Dariohealth, Genoox, Healthverity, Mynd Life Sciences, Neurometrix, Ondine Biomedical, Pavmed.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Pfizer.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Brickell, Bristol Myers, Celltrion, Denali, G1, Genetx, Inhalon, Jounce, Minervax, Timber, Ultragenyx.
Brii Biosciences Ltd. shared interim data from a phase III trial of its neutralizing monoclonal antibody (mAb) combination therapy for SARS-CoV-2, BRII-196 and BRII-198, that showed a 78% reduction in the risk of hospitalization or death in patients receiving single dose of the cocktail.