Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Aptorum, Athersys, Biontech, Equillium, Flexion, Istari, Kamada, Nascent, Outlook, Pfizer, Pharnext, Regeneron.
If these top-line phase III results were a grade card for 12- to 15-year-olds, they would be on the honor roll: The Pfizer Inc.-Biontech SE COVID-19 vaccine is 100% effective for the age group and produced robust antibody responses.
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.