An evolving COVID-19 treatment paradigm may have foiled Mesoblast Ltd.’s phase III with remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS), CEO Silviu Itescu said, but hope remains in pediatric steroid-refractory acute graft-vs.-host disease (GVHD).
Edwards Lifesciences Corp. launched a pivotal trial of its mitral valve repair system in the U.S., with the first patient undergoing treatment for severe degenerative mitral valve regurgitation at the University of Maryland Medical Center in Baltimore. Open-heart surgery is the current standard approach to mitral valve repair, but the Harpoon Beating Heart mitral valve repair system allows surgeons to use a minimally invasive approach, according to Edwards Lifesciences.
The challenging mucositis space chalked up another failure in dusquetide, the innate defense regulator from Soligenix Inc., which fell short in a pivotal, phase III study that enrolled 268 patients to test the small-molecule peptide. “We sort of thought so,” Dawson James analyst Jason Kolbert in a Dec. 22 report, with a neutral rating and no price target.
Amsterdam-based Uniqure NV’s regulatory hitch with its highly regarded hemophilia B program had analysts questioning during a conference call what the development might mean for the company’s deal with CSL Ltd.
Researchers at Thomas Jefferson University have found that using ultrasound to pop microbubbles already present in a contrast agent nearly doubled liver tumor response to transarterial radioembolization. The procedure raised no safety concerns and increased the likelihood of patients receiving a liver transplant.
Eyenovia Inc., a clinical-stage ophthalmic biopharmaceutical firm, has launched a phase III trial of its on-demand treatment for presbyopia, an age-related worsening in near vision. The treatment, called Microline, is a proprietary formulation of pilocarpine delivered via a microdosing dispenser.
In the second half of November, Black Diamond Therapeutics Inc. gained attention from Wall Street by nominating BDTX-1535 as the firm’s development candidate for glioblastoma multiforme (GBM) and kicked off IND-enabling studies.