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The role of diagnostic and surveillance testing in the COVID-19 pandemic is unquestionably critical, but the volume and type of tests needed to bring the economy back online is complex. Susan Van Meter, director of Advamed Dx, said on an April 22 press briefing that while molecular and serological tests will continue to play a vital role, “we’re going to see millions of antigen tests available in the coming weeks,” a development that will prove crucial in efforts to restore normal economic activity.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Predictive Technology Group, SC Worx, Spectrum DNA.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Life Spine, Mobidiag, Seegene.
Recent seizures of fake medical products being marketed in the COVID-19 pandemic underscore the need to curb the growing international trade in counterfeit drugs that’s putting hundreds of thousands of lives at risk, the Organisation for Economic Cooperation and Development (OECD) warned this week.
BEIJING – Nanobody startup Sysvax Inc., with its R&D center in Beijing and manufacturing facilities in Zhongshan, is developing a recombinant protein vaccine and a nanobody therapeutic for COVID-19, while trying to extend the half-life of potential COVID-19 treatments with its expertise in this smallest possible antibody format.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Algernon, Biontech, Clarity, Janssen, Mallinckrodt, Novartis, Pfizer, Vitro.
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