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.
Tyto Care Ltd. nabbed $50 million in an oversubscribed round of funding the company will use to expand commercialization of its integrated telehealth platform and remote device with examination tools, which has seen a surge in demand with COVID-19. The new cash nearly doubles the New York-based company's total funding, bringing it to $105 million. Insight Partners, Olive Tree Ventures, and Qualcomm Ventures LLC led the latest round.
Amid the COVID-19 pandemic, Genmark Diagnostics Inc., of Carlsbad, Calif., has offered a preliminary look at its first-quarter results. And it is forecasting hopeful news, increasing its full-year guidance to a range of $112 million to $122 million. That's up from a previous prediction of $100 million to $110 million.
HONG KONG – India has lifted some restrictions on the export of its medical supplies in light of the global battle against the COVID-19 novel coronavirus. Last month, Indian authorities started restricting the export of certain active pharmaceutical ingredients (APIs) and the formulations based on some specific APIs.