Biogen Idec galiximab starts Phase III
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Biogen Idec has initiated a Phase III trial of its anti-CD80 monoclonal antibody galiximab for follicular non-Hodgkin's lymphoma. The TARGET trial (Targeted Antibody Therapy with Rituxan and Galiximab Efficacy Trial ) will compare treatment with galiximab in combination with Genentech/Biogen Idec's Rituxan (rituximab) in patients with follicular NHL who have relapsed or failed to respond to initial therapy. Conducted under a special protocol assessment, the trial enrolled its first patient in November 2006, and will enroll roughly 700 patients at more than 150 centers worldwide. Progression-free survival is the primary endpoint. The company told Pharmaceutical Approvals Monthly that it hopes to file the galiximab BLA for follicular NHL by mid-2010...
You may also be interested in...
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.
Takeda, Astellas Found New JV To Support Japanese Bioventures
Major Japanese companies Takeda, Astellas and SMBC are joining hands to establish a new joint venture with $3.9m capital and based in Japan’s largest biocluster Shonan iPark to help incubate local biopharma start-ups.
Could Eledon’s Anti-CD40L Change Transplant Medicine?
Eledon Pharmaceuticals’ CD40 Ligand blocker has yielded impressive results for post-transplant immunosuppression and cutting-edge transplant doctors have also used it for pig-to-human kidney and heart transplants, opening up the field of xenotransplantation.