Gilead Company Kite submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Researchers from the Abramson Cancer Center of the University of Pennsylvania described a death receptor pathway in cancer cells that has a primary role in its response to CAR-T cells.
Amgen announced that the results of a prespecified interim analysis of an open-label, randomized, controlled global multicenter Phase 3 trial (20120215) showed that the primary endpoint of event-free survival was met.
Amgen announced that the European Commission approved an expanded indication for Blincyto monotherapy to include adult patients with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1 percent.
Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration expanded the indication for Sprycel tablets to include the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.
The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion to expand the current indication for Amgen Inc.’s Blincyto (blinatumomab) monotherapy to include adult patients with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1 percent.
Affimed N.V. put on hold the testing of the drug developer’s experimental cancer drug following the death of a patient and two life-threatening events.
Novartis received European approval for Kymriah, the Swiss drugmaker’s gene-modifying therapy for blood cancer.
Fast Company recently published The World’s 50 Most Innovative Companies 2018, topping off its edition of the top 350 most innovative companies. Here is a look at the life science companies that made the list.
As part of the company’s fourth-quarter 2017 earnings report, Paris-based Sanofi released a pipeline update showing it plans to halt several mid-stage drug programs.