Clinical updates, including trial initiations, enrollment status and data readouts and publications: Black Diamond, BMS, Emergex, Kinnate, Lumen, Nektar, Revive.
The FDA has granted an emergency use authorization (EUA) to Inspect IR Systems LLC, of Frisco, Texas, for the company’s namesake test that evaluates the patient’s breath for the presence of volatile organic compounds (VOC) indicative of the SARS-CoV-2 virus. The test is expected to increase the volume of testing by only 64,000 per month at the current rate of production, however, making this a technological breakthrough of limited impact on the COVID-19 pandemic.
An interdisciplinary research team from the Hong Kong Polytechnic University has developed a portable testing device that can detect the COVID-19 virus within 40 minutes.
In its first report on device application processing times since it completed most of its medical device reforms, Australia’s Therapeutic Goods Administration (TGA) met all the legislated time frames for processing medical device applications during the six-month period from July 31 to December 2021.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Astellas, Coherus, Innovent, Inxmed, Merck, PTC, Regeneron.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, Biontech Calcimedica, Evelo, Exelixis, Genmab, Inmune, ISA, Lexaria, Marinus, Pfizer, Sanofi, Sciwind, Surface, Taurx, Vendanta.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fosun Diagnostics.
The U.K.’s drugs regulator has approved the COVID-19 vaccine from Valneva SE – although the shot is likely only to be offered to health workers in Scotland after the Westminster government rejected it because rivals beat it to market.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affamed, Atyr, Biogen, Boehringer, Briacell, Direct, Eli Lilly, Novavax, Recbio.
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