The latest global regulatory news, changes and updates affecting biopharma, including: MRNA vaccine efficacy holds in real world; TGA addressing drug shortages; STIs on the rise in U.S.; CDER firm on Makena withdrawal.
Thermo Fisher Scientific Inc. has launched a surveillance system that can detect SARS-CoV-2 in ambient air in indoor spaces, providing a potential complement to individual testing and other COVID-19 safety protocols. The system, called the Aerosolsense Sampler, works by capturing a sample of the ambient air on a cartridge using Thermo Fisher’s collection substrate.
LONDON – Getting a handle on the specificity and sensitivity of rapid COVID-19 antibody tests, how they compare to each other and how they should be applied in population screening to understand who has had the virus and how it has spread, has been a source of difficulty and dispute between manufacturers, clinicians and public health experts.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Helius Medical Technologies, Medtronic, Qiagen, STS Lab.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aurora Spine, Batm, Bracco Diagnostics, Cardionavix, Casamba, Coloplast, Escher Biomedical Diagnostics, Health Logic Interactive, Hitachi, Hoya, Lumendi, Meso Scale Diagnostics, Net Health Systems, Orbita, Philips, Vizient.
Shares of Humanigen Inc. (NASDAQ:HGEN) leapt 54.5% to $21.61 March 29 on news that its monoclonal antibody, lenzilumab, improved the relative likelihood of survival without mechanical ventilation in hospitalized patients with COVID-19, setting the company up to submit an application for emergency use authorization (EUA) in the U.S. "as soon as possible," it said. Separately, a combination of two monoclonal antibodies, the Eli Lilly and Co.-Abcellera Biologics Inc.-developed therapy bamlanivimab and the Vir Biotechnology Inc.-Glaxosmithkline plc candidate VIR-7831, demonstrated a 70% relative reduction in persistently high SARS-CoV-2 viral load at day seven compared to placebo for low-risk adult patients with mild to moderate COVID-19, the companies reported.
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