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.
ImmunityBio begins phase I trial for its COVID-19 vaccine candidate
October 15, 2020 -- ImmunityBio has been authorized by the U.S. Food and Drug Administration to begin a phase I clinical trial of its hAd5-COVID-19 vaccine candidate.
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.
Atum licenses cell line development tools to Rentschler Biopharma
October 14, 2020 -- Rentschler Biopharma has signed a full contract development and manufacturing organization license agreement for Atum's leap-in transposase platform.
Boehringer Ingelheim, Oxford BioTherapeutics partner further on antibodies
October 14, 2020 -- Boehringer Ingelheim and Oxford BioTherapeutics are partnering to discover novel targets for cancer immunotherapies using the Oxford Genome Anatomy Project's T-cell engager, cancer vaccine, and oncolytic virus platforms.
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.
Lineage Cell, Cancer Research U.K. advance cancer vaccine
October 13, 2020 -- Lineage Cell Therapeutics and partner Cancer Research U.K. have posted positive preliminary phase I results from an ongoing study of VAC2 in non-small cell lung cancer.
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