Clinicians at the University of Maryland have transplanted a heart from a genetically modified pig bred by Revivicor Inc., a subsidiary of United Therapeutics Corp., into a patient with end-stage heart failure.

Researchers at the Feinstein Institutes for Medical Research, the research arm of New York-based Northwell Health, illuminated the precise pathway from the brainstem to the spleen that controls inflammation in a study published in the Proceedings of the National Academy of Sciences of the United States of America (PNAS). Essentially, the work demonstrates how scientists could use the vagus nerve to hack the immune system, enabling them to turn down the excessive response that underlies autoimmune disease without the use of biologics or immunosuppressive drugs.

A multi-institutional team of researchers has implicated lipid droplets, which are key energy storage units of individual cells, in innate immune defense. "Until now it was thought that [lipid droplets] were at the service of viruses or bacteria during infection," Albert Pol told BioWorld. The new study, which was published in the Oct. 16, 2020, issue of Science, demonstrated that cells also use the droplets to coordinate their defense.

The matter of how adhesion of its Viaskin Peanut allergy patch relates to efficacy became a major problem for DBV Technologies SA, which drew a complete response letter (CRL) for the once-daily epicutaneous (EPIT) product. Shares of the Montrouge, France-based firm (NASDAQ:DBVT) closed Aug. 4 at $2.34, down $1.76, or 43%, in reaction to the CRL for the patch, designed to protect children ages 4 to 11. The FDA wants DBV to modify the patch, which means a new human-factor study; officials also are requiring clinical data for the modified patch.

Navidea Biopharmaceuticals Inc. CEO Jed Latkin said positive findings from the second interim analysis of the phase IIb study called NAV3-31 “were certainly better than what we were looking for” and will “make our partnering discussions a lot more interesting.”

PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. announced that the FDA has accepted its BLA for priority review for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, for children with acute steroid-refractory graft-vs.-host disease (aGVHD).