Researchers affiliated with the Cancer Center at Illinois discovered a novel small molecule compound that is now the subject of a new global licensing agreement between the pharmaceutical company Bayer AG and the cancer drug development company Systems Oncology LLC.
Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, and US Oncology Research, one of the largest community-based oncology site management organizations in the U.S., announced a collaboration to utilize the US Oncology Research Selected Trials for Accelerated Rollout (STAR) program for patient enrollment in the registration-enabling Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 gene fusion.
The Reagan-Udall Foundation for the FDA, with input from experts at FDA, has introduced an Expanded Access eRequest app to streamline expanded access for individual patients in non-emergency settings.
FDA has accepted the Biologics License Application for idecabtagene vicleucel (ide-cel; bb2121) as Priority Review.
Agenus Inc. has begun the rolling submission of its Biologics License Application FDA for balstilimab alone for the treatment of recurrent/metastatic cervical cancer.
FDA has accepted and granted priority review to the supplemental New Drug Application for Xalkori for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase-positive.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for GSK's Zejula (niraparib) as a first-line maintenance treatment in women with advanced ovarian cancer who responded to platinum-based chemotherapy, regardless of biomarker status.
FDA has granted Rhenium NanoLiposomes Fast Track Designation for the treatment of patients with recurrent glioblastoma.
Elicio Therapeutics and Moffitt Cancer Center are collaborating to characterize combination therapies pairing Elicio's CD19 Amphiphile and a universal FITC Amphiphile with CD19 CAR T cells.
Physicians at the University of California, San Diego School of Medicine and Cofactor Genomics are working to improve the ability to predict tumor response to immunotherapy in recurrent and metastatic squamous cell carcinoma of the head and neck.
