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.
Cigna Corp. issued a positive coverage decision for VeriStrat serum proteomic testing developed by Biodesix Inc. Cigna published its position to extend coverage for the VeriStrat blood-based test, stating the test is “…medically necessary for an individual with advanced non-small cell lung cancer (NSCLC)…”
Amgen and Roche announced they will collaborate on a phase Ib study to evaluate the safety and efficacy of talimogene laherparepvec, Amgen's investigational oncolytic immunotherapy, in combination with Roche's investigational anti-PDL1 therapy, atezolizumab (also known as MPDL3280A), in patients with triple-negative breast cancer and colorectal cancer with liver metastases.
Advaxis Inc. submitted a Special Protocol Assessment request to the FDA to initiate detailed design discussions for a phase III clinical study of ADXS-HPV for the treatment of high-risk, locally advanced cervical cancer.
FDA approved the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to aid in the identification of patients for Pfizer's targeted therapy, Xalkori (crizotinib).
The European Commission has granted marketing authorization for Gardasil 9.
