Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Biolinerx, BMS, Chiesi, Mersana, Vaxxinity.
Invivyd Inc. (formerly Adagio Therapeutics Inc.) has generated multiple next-generation candidate antibodies for the prevention and treatment of COVID-19, including two molecules designated for near-term clinical development in combination as NVD-200.
Researchers from Boston Children’s Hospital and Harvard Medical School reported the discovery and preclinical evaluation of SP1-77, a novel humanized monoclonal IgG-κ antibody targeting the receptor-binding-domain (RBD) of spike (S) glycoprotein of all SARS-CoV-2 variants.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adagio, Adial, Alume, Aptose, Attralus, Azura, Bavarian Nordic, Celgren, Cellusion, Epivax, Fosun, Infexious, Intravacc, Invivyd, Purnovate.
Intravacc BV has announced additional preclinical and toxicology data for Avacc 10, the company's SARS-CoV-2 intranasal candidate vaccine, showing a reduction in upper respiratory tract viral load, broad cross protection against circulating variants of concern and a promising safety profile.
A team of researchers at Toyohashi University of Technology in Japan have come up with a semiconductor sensor that can detect minute traces of biomarkers for infections or diseases.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Neuroplast, Revance, Silence, Vanda, Veru, Yishengbio.
Inflarx NV is poised to apply for U.S. FDA emergency use authorization for its complement inhibitor, vilobelimab, in treating seriously ill, mechanically ventilated COVID-19 patients, following a reappraisal of the statistical analysis of the 369-patient placebo-controlled phase III trial.
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