FDA approved Imlygic (talimogene laherparepvec) as the first oncolytic viral therapy in the U.S.
FDA granted de novo clearance to SonaCare Medical LLC to market the Sonablate 450 in the U.S. for the ablation of prostate tissue.
FDA approved Yondelis (trabectedin) for the treatment of liposarcoma and leiomyosarcoma that cannot be removed by surgery or is metastatic. This treatment is approved for patients who previously received chemotherapy that contained anthracycline.
FDA approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. The agency previously granted Priority Review and orphan drug designations for Onivyde.
Sequenom Inc. entered into a clinical collaboration with University Medical Center Hamburg-Eppendorf in Germany. They will collaborate to profile circulating cell-free tumor DNA in blood to monitor response to treatment in later stage colorectal cancer patients.
Eli Lilly and Co. and Innovent Biologics Inc. expanded their drug development collaboration to support the development and potential commercialization of up to three anti-PD-1 based bispecific antibodies for cancer treatments over the next decade, both inside and outside of China.
The Ontario Institute for Cancer Research and Novera Therapeutics Inc. will collaborate with Janssen Biotech, a pharmaceutical company of Johnson & Johnson, to develop small molecule drug candidates for hematological cancers.
Genentech and Arvinas Inc. entered into a license agreement for the development of new therapeutics using Arvinas' PROTAC technology. The multi-year strategic license agreement encompasses multiple disease targets.
The European Medicines Agency granted an Orphan Drug Designation to ENMD-2076, developed by CASI Pharmaceuticals Inc., for the treatment of hepatocellular carcinoma, including fibrolamellar carcinoma, a rare type of HCC.
MedImmune joined the Human Vaccines Project, a public-private partnership seeking to develop new vaccines and immunotherapies.
