The latest global regulatory news, changes and updates affecting medical devices and technologies, including: American Telemedicine Association, Heraeus, Zimmer Biomet.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3D Med, 7D Surgical, Abiomed, Invo Bioscience, M.I. Tech, Todos Medical.
Courtesy of a $50 million series A, Adagio Therapeutics Inc. will join a raft of other companies attempting to end the COVID-19 pandemic with antibodies.
LONDON – Pharmaceutical companies and academic researchers working on COVID-19 vaccines are being targeted by Russian state-sponsored hackers, according to the U.K. National Cyber Security Centre (NCSC). The U.K. view is endorsed by the U.S. National Security Agency and Canada’s Communications Security Establishment, and the three agencies have issued a joint statement advising companies how to protect against these attacks.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clinical Computer Systems, Diacarta, Edwards, Huntleigh Healthcare, Icad, Paragon 28.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Astrazeneca, Bayer, Kiniksa, Mallinckrodt, MC2, Merck, Redhill, Tetra, Tracon and Tricida.
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