The U.S. FDA gave an emergency use authorization (EUA) to the first semi-quantitative antibody test from Siemens Healthineers AG for the SARS-CoV-2 virus. This test, known as the SARS-CoV-2 IgG (COV2G) antibody test, could potentially be used repeatedly over time to assess relative levels to gauge potential immunity.
Orthopedic companies felt pressure from COVID-19 in their most recent quarters. For example, Zimmer Biomet Holdings Inc. reported second-quarter net sales of $1.226 billion, a decrease of 38.3% from the prior-year period. Still, those revenues did come ahead of expectations, as Wells Fargo analyst Larry Biegelsen noted – $432 million ahead of his group's estimate and $305 million ahead of consensus.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Biotricity, Siemens Healthineers.
Keeping you up to date on recent developments in oncology, including: Cancer follow-up plummeted in Wuhan after onset of COVID-19 pandemic; T-cell receptor sequencing proves useful for tracking thyroid cancer; Silver nanowires take their place in brain cancer therapy.
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.
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