James M

Global governance is broken at a dangerous time, writes James M. Boughton.

Long-term care providers have a lot to be grateful for and, no, this isn’t an early start on a perfunctory Thanksgiving column.

Adeno-associated virus (AAV) vector gene therapy is a promising approach to treat rare genetic diseases; however, an ongoing challenge is how to best modulate host immunity to improve transduction efficiency and therapeutic outcomes. This report presents two studies characterizing multiple prophylactic immunosuppression regimens in male cynomolgus macaques receiving an AAVrh10 gene therapy vector expressing human coagulation factor VIII (hFVIII). In study 1, no immunosuppression was compared with prednisolone, rapamycin (or sirolimus), rapamycin and cyclosporin A in combination, and cyclosporin A and azathioprine in combination. Prednisolone alone demonstrated higher mean peripheral blood hFVIII expression; however, this was not sustained upon taper. Anti-capsid and anti-hFVIII antibody responses were robust, and vector genomes and transgene mRNA levels were similar to no immunosuppression at necropsy. Study 2 compared no immunosuppression with prednisolone alone or in combination with rapamycin or methotrexate. The prednisolone/rapamycin group demonstrated an increase in mean hFVIII expression and a mean delay in anti-capsid IgG development until after rapamycin taper. Additionally, a significant reduction in the plasma cell gene signature was observed with prednisolone/rapamycin, suggesting that rapamycin’s tolerogenic effects may include plasma cell differentiation blockade. Immunosuppression with prednisolone and rapamycin in combination could improve therapeutic outcomes in AAV vector gene therapy.

With the shocking October 7 Hamas assault on Israeli citizens, and what is expected to be a ferocious Israeli response, Israel’s political parties, neighbors,

The U.S. Navy marks 248 years of service.

Hamas planned and conducted the attack with a barbarism that they knew would trigger a significantly intense Israeli response

Longevity Health Plan and Humana Inc. have announced that their managed care partnership has picked up speed with a new caregiving collaboration with Touchstone Communities. They have formed an Independent Provider Association that will serve Humana members living in Texas starting in 2024.

It's been a while (since mid-2021) since we last updated our cheat sheet devoted to eDiscovery for defendants. That's because, unlike most of our…

According to a recent decision, one Pennsylvania court thinks that the answer is “yes.” Simon v. First Savings Bank of Indiana, 2023 WL 5985282 (E.D…

Shiba Inu-themed restaurant has hinted at a grand opening for later this month stirring excitement in the SHIB community.