Leal, formerly known as Trialjectory, has established a proprietary platform for oncologists to quickly identify personalized clinical trial matches for their patients, reducing reliance on unstructured data and expediting patient treatment identification / clinical trial enrollment. The platform is free for oncologists.
FDA granted accelerated approval to Epkinly (epcoritamab-bysp) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
The Wistar Institute, the Pennsylvania Biotechnology Center, and the Baruch S. Blumberg Institute formed a collaboration to accelerate the advancement of “bench to bedside” biomedical research discoveries in Pennsylvania, New Jersey, and Delaware by collectively supporting the seeding, launching, and maturation of life science startups.
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FDA released a draft guidance, “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” to support the use of decentralized clinical trials for drugs, biologics and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.
