Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerapedics, Controlrad, Eurobio Scientific, Fibralign, GE Healthcare, Genmark Diagnostics.
What’s the plan? The U.S. CDC is being asked that question a lot these days – not just about COVID-19, but also about preparing for what could be a tough influenza season as flu bugs circulate with the coronavirus.
The latest global regulatory news, changes and updates affecting biopharma, including: NIH adds funding to Latino Alzheimer’s research; Sprout warned for Addyi promotion; Scripps to pay $10M over use of NIH grants.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied Spectral Imaging, Astrazeneca, Avita Therapeutics, Bio-Techne, Guided Therapeutics, Kantaro Biosciences, Luminultra, Meridian, Mimedx, Mount Sinai Health, Natera, Nevro, Shandong Yaohua Medical Instrument, Staar Surgical, Telo Genomics, Thermo Fisher Scientific, Transenterix.
HONG KONG – Interim results of a phase I study CT-P59, an anti-COVID-19 monoclonal antibody being developed by Incheon, South Korea-based Celltrion Inc., have confirmed the candidate’s safety, tolerability and pharmacokinetics in healthy subjects, giving the company confidence to ramp up production of the experimental antiviral.
The Astrazeneca plc and Oxford University phase III trial of their adenovirus-based coronavirus vaccine is back up and running in the U.K. after a week’s worth of study and decision-making. The company said it still plans to report data from the study by the end of this year.
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