Due to the pressing challenges of COVID-19, Health Canada is giving drug companies six more months to prepare for major reforms to its 1987 Patented Medicines Regulations.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biophytis, BMS, CNS, Diffusion, Eyegate, Genequantum, Inmune, Intelgenx, Lannett, Leo, Mylan, Novartis, Pfizer.
Cue Health Inc. scooped up $100 million in a series C round to support the launch of its rapid molecular testing platform. The funds will be used to finalize the development and validation of the Cue Health Monitoring System and Cue Test Cartridges, as well as to scale up manufacturing operations.
The impact of the COVID-19 pandemic has reached into quarters that are not historically problematic for makers of diagnostics, including China’s import and export practices for test kits. According to one caller on an FDA diagnostic town hall, export officials in China have a blacklist and a whitelist for test kits, but there is some dispute as to whether kits that are eligible for distribution in the U.S. can get off the blacklist unless that kit is specifically called out via the emergency use authorization (EUA) program.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chromacode, Illumina, Quidel.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: AACC, Akadeum, Calmare Therapeutics, Cota, Curadigm, Healgen, Helixbind, Hematogenix, Huma, Menarini Silicon Biosystems, Nanobiotix, Nanocellect, Neuspera, Orasure Technologies, Roche, Tyto Care, Vivera Pharmaceuticals.
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