Atlantic Health System’s Atlantic Health BioBank partnered with NCI’s Cooperative Human Tissue Network Southern Division. The collaboration between Atlantic Health System and NCI will help provide clinical researchers with the resources they need to advance the science of medicine.
FDA granted PYX-201 Orphan Drug Designation in pancreatic cancer.
Leal, formerly known as Trialjectory, has established a predictive patient platform
FDA approved the Premarket Approval application for xT CDx, a 648-gene next-generation sequencing test for solid tumor profiling, which includes microsatellite instability status and companion diagnostic claims for colorectal cancer patients.
FDA released a draft guidance, “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” to support the use of decentralized clinical trials for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites.
The European Commission approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor T-cell therapy, for the treatment of adult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
FDA accepted the supplemental Biologics License Application sBLA and the European Medicines Agency has validated the Type II Variation Application for Reblozyl (luspatercept-aamt) to expand its current indication to include treatment of anemia without previous use of erythropoiesis-stimulating agents in adult patients with very low- to intermediate-risk myelodysplastic syndromes who may require red blood cell transfusions.
FDA granted Fast Track designation for ¹⁷⁷Lu-PNT2002 for the treatment of metastatic castration resistant prostate cancer.
MD Anderson Cancer Center and Generate:Biomedicines formed a strategic collaboration to jointly discover and co-develop protein therapeutics for up to five oncology targets in advanced cancers, including small-cell and non-small-cell lung cancer.
NeraCare formed a strategic partnership with SkylineDx, which includes an exclusive co-development and licensing agreement for Immunoprint, a proteomic test used to identify early-stage melanoma patients at high risk of relapse and death.
