FDA approved a single-dose, prefilled autoinjector presentation of Udenyca (pegfilgrastim-cbqv), a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. The Udenyca autoinjector has a streamlined, easy-to-use design for use in both in-office and at-home settings of care.
FDA published updates to the mammography regulations to, among other things, require mammography facilities to notify patients about the density of their breasts, strengthen the FDA’s oversight and enforcement of facilities and help interpreting physicians better categorize and assess mammograms.
Point32Health, the parent company of Harvard Pilgrim Health Care and Tufts Health Plan, and Foundation Medicine, have entered into a value-based agreement to make FoundationOne®CDx and FoundationOne®Liquid CDx, FDA-approved comprehensive genomic profiling tests, available to Point32Health members with advanced cancer, including Medicaid members.
C2i Genomics entered a collaboration agreement March 2 with Riken Genesis Co., Ltd. to bring MRD cancer monitoring to Japan for pharmaceutical and clinical research.
HRA Pharma Rare Diseases, a business of Perrigo Company, signed a partnership with Celnova Pharma, to ensure that the products developed by HRA Pharma Rare Diseases can be successfully registered and launched across Argentina, Chile, and Peru.
Gritstone bio Inc., entered into a clinical trial agreement with NCI to evaluate an autologous T-cell therapy expressing a T-cell receptor targeting mutated KRAS in combination with Gritstone’s KRAS-directed vaccine candidate, SLATE-KRAS, in a phase I study. The study will be led by Steven A. Rosenberg, chief of the surgery branch at NCI’s Center for Cancer Research.
MD Anderson Cancer Center and Xilis formed a strategic collaboration to use Xilis’ proprietary MicroOrganoSphere technology in support of preclinical research to accelerate the development of novel cancer therapies.
FDA approved Jemperli (dostarlimab-gxly) for adult patients with mismatch repair deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
Absci Corporation and St. John’s Cancer Institute entered into a partnership to uncover breakthrough cancer therapies. The partnership will leverage Absci’s Integrated Drug Creation platform, which combines generative AI models and proprietary wet-lab technologies, and SJCI’s cancer biospecimen repository and molecular database to quickly identify new therapeutic candidates with the potential for higher probability of clinical success.
FDA granted accelerated approval to Jaypirca (pirtobrutinib) for relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
