The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Krishnamoorthi eyes ventilator contract; TGA fines company for failure to provide masks; U.S. PPE hoarder indicted; CAP supports Defense Production Act; South African variant in U.S.; GAO: More needs to be done to respond to COVID-19; Biden orders review of scientific-integrity policies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Medtech, DNA Genotekm, Global Instrumentation, Perspectum.
HONG KONG – Osaka, Japan-based Shionogi & Co. Ltd. has inked a license agreement with Bioage Labs Inc. that sets the stage for the Richmond, Calif.-based startup to test asapiprant, originally developed for allergic rhinitis, for the treatment of COVID-19 and age-related declines in immune function.
The latest global regulatory news, changes and updates affecting biopharma, including: Biden orders review of scientific-integrity policies; Canada to build rare disease drug strategy; South African variant in U.S..
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Bio-Thera, Harbour, Immunoforge, Kintor, M6P, Opko, Passage, Pfizer.
The SARS-CoV-2 virus has now had ample time to mutate, as reports of the proliferation of multiple variants make clear, and the U.S. FDA’s Tim Stenzel said the agency is now focused on three variants, including one recently reported from Israel. Stenzel said on the latest COVID-19 testing town hall that one of the key concerns regarding existing authorized tests is the potential for loss of sensitivity, a problem the agency hopes to overcome without the use of live virus.