Japan's Ministry of Health, Labour and Welfare has approved Myriad Genetics' BRACAnalysis Diagnostic System to help physicians determine which women with breast cancer have Hereditary Breast and Ovarian Cancer syndrome and qualify for additional medical management.
FDA granted Exact Sciences' DNA methylation based liquid biopsy test Breakthrough Device designation for detection of hepatocellular carcinoma, based on recently presented data.
FDA has accepted Bristol-Myers Squibb's supplemental Biologics License Application and granted Breakthrough Therapy Designation for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with advanced hepatocellular carcinoma previously treated with sorafenib.
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a supplemental New Drug Application to FDA seeking approval to expand the Imbruvica (ibrutinib) label to include the combination with rituximab for the first-line treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Health Canada has approved Imbruvica (ibrutinib) in combination with obinutuzumab for treatment-naïve patients with active chronic lymphocytic leukemia.
UroGen Pharma paid $10 million to Agenus Inc. for access to zalifrelimab (AGEN1884, anti-CTLA-4 antibody) for use with sustained release technology for intravesical delivery in patients with urinary tract cancers.
Project GENIE (Genomics Evidence Neoplasia Information Exchange), an initiative by the American Association for Cancer Research, is launching a five-year, $36 million research collaboration with nine biopharmaceutical companies to obtain clinical and genomic data from an estimated 50,000 de-identified patients.
The European Commission has approved Astellas' oral once-daily therapy Xospata (gilteritinib) as a monotherapy for the treatment of adult patients with relapsed or refractory (resistant to treatment) acute myeloid leukemia with a FLT3 mutation. Gilteritinib has the potential to improve treatment outcomes for AML patients with two forms of the most common mutation—FLT3 internal tandem duplication and FLT3 tyrosine kinase domain mutation.
FDA granted Shreis Scalene Sciences Breakthrough Device Designation for the Cytotron, a CE-marked, whole-body therapeutic medical device. The Center for Devices and Radiological Health granted the designation. The company’s designation request stated that “The Cytotron is intended to be used to cause degeneration of uncontrolled growth of tissues. It is indicated for treating protein-linked, abnormally […]
Ziopharm Oncology Inc. and MD Anderson Cancer Center established a research and development agreement relating to Ziopharm’s Sleeping Beauty immunotherapy program to use non-viral gene transfer to stably express and clinically evaluate neoantigen-specific T-cell receptors in T cells. “This new agreement is a launch point to expand our TCR library and execute two new clinical […]
