FDA granted an Orphan Drug Designation to Cleave Biosciences' lead drug candidate, CB-5083, for treatment of multiple myeloma.CB-5083 is a first-in-class, oral inhibitor of p97, an enzyme that controls various aspects of protein homeostasis.
The European Commission approved Imbruvica capsules (ibrutinib) for adult patients with Waldenstrom's macroglobulinemia who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
FDA granted an Orphan Drug Designation to ImMucin for the treatment of multiple myeloma, developed by Vaxil Bio.
Eli Lilly and Co. and Immunocore Ltd. entered into an immunotherapy-based clinical trial collaboration to explore the utility of Immunocore's lead T cell receptor-based investigational therapeutic, IMCgp100, in combination with Lilly's galunisertib (LY2157299) and merestinib (LY2801653).
Proton Partners International Ltd. acquired the site for the first high energy proton beam therapy cancer treatment center will be built in the U.K.
Mevion Medical Systems delivered a superconducting synchrocyclotron accelerator for its Mevion S250 proton therapy system under installation at University Hospitals Seidman Cancer Center and UH Rainbow Babies & Children's Hospital in Cleveland.
The Leukemia & Lymphoma Society accelerated a portion of the final payment linked to the phase III study of CPX-351 (cytarabine:daunorubicin) liposome injection, Celator Pharmaceuticals' lead product candidate, for the treatment of patients with high-risk acute myeloid leukemia.
The European Medicines Agency granted accelerated approval to Opdivo (nivolumab) for the treatment of metastatic melanoma.
FDA granted Priority Review to MM-398 for the treatment of metastatic adenocarcinoma of the pancreas following a gemcitabine-based therapy.
Soligenix Inc. will collaborate with the National Organization for Rare Disorders and the Cutaneous Lymphoma Foundation to recruit patients for its phase III clinical study of SGX301 (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma.
