The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval for the expanded use of guselkumab (Tremfya), a monoclonal antibody (mAb) from the Janssen Pharmaceutical Companies of Johnson & Johnson.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) posted a positive opinion recommending approval for Alnylam Pharmaceutical's lumasiran, an investigational RNA interference (RNAi) therapeutic for the treatment of primary hyperoxaluria type 1.
The U.S. National Institutes of Health (NIH) has launched an adaptive phase III trial called Accelerating COVID-19 Therapeutics 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 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.
Thermo Fisher Scientific has launched the Gibco CTS Rotea counterflow centrifugation system, a modular, closed cell therapy processing system for cell therapy development and manufacturing.
Castle Creek Biosciences has initiated a phase I/II clinical trial evaluating FCX-013, the company's investigational gene therapy for the treatment of moderate to severe localized scleroderma.
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 BioPharmaceuticals is touting positive clinical results from a study conducted at the University of Toronto for its COVID-19 immunotherapy, peginterferon lambda (Lambda).
Cellaria has launched three new cell lines for pancreatic cancer that it hopes will improve patient care by improving the value of in vitro methods of developing therapies.
Sestina Bio, a new company developing an automated synthetic biology platform, has been launched with seed funding. Sestina also is the first company to be launched from the Foresite Labs incubator.
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