Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Binx Health, Gold Standard Diagnostics, Nines.
The latest salvo in the debate over patents protecting COVID-19-related drugs, devices and vaccines came this week from U.S. industry organizations, including Advamed, the Biotechnology Innovation Organization and the Pharmaceutical Research and Manufacturers of America.
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.
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