The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed, Boston Scientific, Clinical Research Consultants, MDMA.
HONG KONG – Incheon, South Korea-based Celltrion Inc. is rapidly advancing CT-P59, its antiviral antibody treatment for the COVID-19 virus, after receiving its second green light to begin phase I trials.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ana, Biophytis, Biosight, Cerecor, DBV, Deciphera, Eloxx, I-Mab, Leo, Myr, Reviral, Vivoryon.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Angion, Arch, Avelas, Cellectar, Clene, Karuna, Keros, GT, Novartis, Oncopeptides, Regenxbio.
TORONTO – Dishing out hundreds of millions of dollars for new COVID-19 fighting ventilators, test kits and antibody detection platforms Ottawa has another vital gap to close: the time it takes to approve these technologies for the marketplace. A new Canadian pilot program could significantly reduce the amount of time it takes to determine if these technologies are ready for prime time.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: American College of Radiology, Asuragen, Bio-Techne, Brain Scientific, China Grand Pharmaceutical and Healthcare, Clinical Reference Laboratory, Co-Diagnostics, Iotron Industries, Kantaro Biosciences, Karius, Medicrea, Mount Sinai Health System, Pacific Biosciences, Personalis, Quest Diagnostics, Renalytix AI, Sirtex Medical, Sotera Health, Sterigenics.
Keeping you up to date on recent developments in cardiology, including: Genetic variants contribute to heightened death risk from stroke in those of African descent; Pathologists publish report on likely MIS involving the heart; Studying COVID-19’s impact on the heart.
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