Tags : Light Chain

Janssen Reports sBLA Submission to the US FDA for Darzalex

Shots: The sBLA submission is based on P-III ANDROMEDA study assessing Darzalex Faspro (SC) + bortezomib, cyclophosphamide, and dexamethasone (D-VCd) vs VCd as monothx. in 388 patients with newly diagnosed (AL) amyloidosis The study resulted in meeting its 1EPs overall hematologic complete response rate. The sBLA is being reviewed under the FDA’s RTOR program and […]Read More

Alexion Collaborates with Caelum Biosciences for its CAEL-101 to Treat

Shots: Alexion and Caelum collaborate for the development of CAEL-101 in PIa/Ib trial and Caelum to receive $60M as an equity investment, near-term milestones & will conduct P-II trial for CAEL-101 to treat Light Chain (AL) Amyloidosis Post-P-II study completion, Alexion will get an exclusive option to acquire Caelum, depending on the results of CAEL-101 […]Read More