Bristol-Myers Squibb announced that Columbia University Medical Center and Peter MacCallum Cancer Centre joined the International Immuno-Oncology Network (II-ON), a global peer-to-peer collaboration between BMS and academia that aims to advance immuno-oncology science and translational medicine to improve patient outcomes.
Exelixis Inc. and Bristol-Myers Squibb Co. entered into a clinical development collaboration to evaluate Cabometyx (cabozantinib), Exelixis' small molecule inhibitor of receptor tyrosine kinases, with BMS's Opdivo (nivolumab), either alone or in combination with Yervoy (ipilimumab).
Exelixis Inc. announced a new collaboration with Roche on a phase Ib dose escalation study that will evaluate the safety and tolerability of cabozantinib, Exelixis' tyrosine kinase inhibitor, in combination with atezolizumab, Roche's anti-PD-L1 immunotherapy, in patients with locally advanced or metastatic solid tumors.
Advaxis Inc. granted SELLAS Life Sciences Group a license to develop a novel cancer immunotherapy agent using Advaxis' proprietary Lm-based antigen delivery technology with SELLAS' patented WT1 targeted heteroclitic peptide antigen mixture (galinpepimut-S).
FDA approved the nivolumab (Opdivo) injection for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
FDA approved the marketing of 23andMe's Bloom Syndrome carrier test, a direct-to-consumer genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the disorder.
FDA approved lenalidomide (Revlimid) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.
Novartis said FDA has accepted the company's supplemental New Drug Application for filing, and granted Priority Review for the expanded use of Zykadia (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive as detected by an FDA-approved test.
Mylan N.V. and Biocon Ltd. said the FDA has accepted Mylan's Biologics License Application for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim), for filing through the 351(k) pathway.
MIODx said it has signed an exclusive license for two key immunotherapy technologies from the University of California, San Francisco.