PERTH, Australia – Mesoblast Ltd. inked an exclusive global licensing deal with Novartis AG for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell product remestemcel-L, with an initial focus on the acute respiratory distress syndrome, including that associated with COVID-19, just six weeks after the FDA issued a complete response letter for the therapy as a treatment for steroid-refractory acute graft-versus-host disease.

The Pharmaceutical Research and Manufacturers Association (PhRMA) filed suit Nov. 23 in U.S. district court challenging the Trump administration’s final rule allowing the import of prescription drugs from Canada.

Four days after receiving European approval, the FDA has followed suit for Alnylam Pharmaceuticals Inc.’s Oxlumo (lumasiran), the first treatment for primary hyperoxaluria type 1, an ultra-rare genetic disorder that contributes to kidney stones and deposits.

SHENZHEN – To accelerate the development of cell therapies, China’s NMPA has introduced a dual-track regulatory pathway that allows companies to seek an IND with data from investigator-initiated trials.