NIH initiates ACTIV trial for COVID-19 immune modulators October 16, 2020 -- The U.S. National Institutes of Health (NIH) has launched an adaptive phase III trial called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-1 Immune Modulators, which is evaluating the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19.
Precigen nabs FDA nod for manufacturing UltraCAR-T therapies October 15, 2020 -- Precigen has been granted clearance by the U.S. Food and Drug Administration (FDA) for its UltraPorator system. The system also had a successful technology transfer to clinical sites and will be used as a manufacturing device for Precigen's investigational UltraCAR-T therapies.
Eiger touts positive results for COVID-19 therapy October 15, 2020 -- Eiger BioPharmaceuticals is touting positive clinical results from a study conducted at the University of Toronto for its COVID-19 immunotherapy, peginterferon lambda (Lambda).
Thermo Fisher to add sterile filling lines in Singapore October 14, 2020 -- Thermo Fisher Scientific will operate a $130 million facility in Singapore that will be used to develop two new sterile filling lines, extending capacity to develop and manufacture therapies and vaccines.
Moderna gets nod from EMA to submit marketing authorization October 14, 2020 -- Moderna has received written confirmation from the European Medicines Agency (EMA) that messenger RNA (mRNA)-1273, the company's COVID-19 vaccine candidate, is eligible for submission of an application for marketing authorization in the European Union.
J&J pauses COVID-19 vaccine trials October 14, 2020 -- Johnson & Johnson on October 12 temporarily paused further dosing in all of its COVID-19 vaccine clinical trials, including the phase III Ensemble trial, due to an unexplained illness in a study participant.