An independent panel to the U.S. Food and Drug Administration voted in favor of approving GlaxoSmithKline’s experimental treatment for a common form of blood cancer, saying the benefits of the treatment outweigh the risks.
GlaxoSmithKline submitted a Biologics License Application to the U.S. FDA based upon results from the pivotal DREAMM-2 Phase III trial of belantamab mafodotin in multiple myeloma.
The U.S. Food and Drug Administration approved Janssen’s Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant.
GlaxoSmithKline said an experimental multiple myeloma treatment showed a meaningful response in patients that have run out of three previous treatment options.
Takeda Pharmaceutical Co. Ltd. posted a 27.9 percent rise in operating profit for the October-December 2018 period, supported by strong sales of the company’s drugs for bowel disease and multiple myeloma.
Bristol-Myers Squibb snagged regulatory approval from the U.S. FDA for Empliciti (elotuzumab) for adults with multiple myeloma who have received at least two prior therapies.
The U.S. FDA granted Priority Review to daratumumab as a combination treatment for patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant.
Cellectar Biosciences is closing its manufacturing operations and contracting them out.
Amgen Inc. said a final analysis of late-stage trial data showed that its Kyprolis combined with two other drugs helped blood cancer patients live longer.
Summit, NJ-based Celgene and Cambridge, Mass.-based bluebird bio released updated data from an ongoing Phase I clinical trial of bb2121 at the American Society of Hematology (ASH) Annual Meeting in Atlanta.