Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanz, Azurity, Emergent Biosolutions, Hutchmed, Kalvista, Moderna, Novavax, Obsidian, Prilenia, Seabelife SAS, Skyline.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avanzanite, Basilea, Bavarian Nordic , Camp4, Invivyd, Johnson & Johnson, JW Therapeutics, Roche, Soleno.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bioarctic AB, Biovie, Invivyd, Lexaria, Spago Nanomedical, Vaderis.
Shares of Chinese and South Korean med-tech companies continued to rise after the World Health Organization declared mpox a public health emergency of international concern Aug. 14 after recent outbreaks.
About two months after Astrazeneca plc said its application for sipavibart (AZD-3152) had been accepted by the EMA for pre-exposure prophylaxis (PrEP) against COVID-19 in immunocompromised people, Invivyd Inc. unveiled positive 180-day exploratory efficacy data from the company’s ongoing Canopy phase III trial with Pemgarda (pemivibart) in the same indication – and made known less happy news from regulators on the other side of the pond.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, I2o, Intarcia, Janssen, Moderna, Pfizer.
Rockefeller University has disclosed non-structural protein 3 (nsp3; PL-PRO) (SARS-CoV-2; COVID-19 virus) inhibitors reported to be useful for the treatment of SARS-CoV-2 infection (COVID-19).
Researchers have identified a gene associated with whether patients hospitalized with respiratory viral infections recover rapidly or face life-threatening complications. The gene has the potential to be used as a diagnostic tool or biomarker, which could help triage patients suffering from severe respiratory infections. Having such a biomarker would help clinicians in their early risk assessments to manage their intervention strategies.
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