Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cipla, Diacarta, DNAe, Vapotherm, Silk Medical Aesthetics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bio-Rad, Boston Scientific, Celsee, Center for Medical Interoperability, Ciox Health, Eclipse Automation, Electrocore, Glaukos, Harmontronics Automation, Labcorp, Lantheus, Markforged, Medtronic, Micron Solutions, Neurophotometrics, Nevro, No Borders, Orthofix, Phase Scientific, Quest.
DUBLIN – The EMA has activated a COVID-19 task force to coordinate and accelerate the European regulatory response to the pandemic. The task force is intended to take a lead role in shaping the development, authorization and post-approval surveillance of drugs and vaccines for treating or preventing COVID-19 infection.
Specific therapies against a new disease take time to develop. But there are methods that can speed up that development – and in the meantime, there are ways to make do with what’s already in the cupboard.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Athenex, Biohaven, Calcimedica, EMD Serono, Kiadis, Lannett, Pfizer, Viracta.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aridis, Bridge, Firstwave, Fujifilm, Kezar, Laurent, Mesoblast, Neoimmunetech, Otonomy, Sirnaomics, Tenax, Vigeo, Zelira.
There will be lessons learned aplenty when the COVID-19 pandemic finally breaks, including how serological and molecular testing can be used to maximum effect to corral a future pandemic. Carmen Wiley, president of the American Association of Clinical Chemistry, told BioWorld that the existing instrument types are up to the job, but that surge capacity is needed, and that it is not clear how the cost of that capacity will be handled.