Using the Real Time Oncology Review pilot program, the U.S. Food and Drug Administration approved Janssen and Genmab’s Darzalex (daratumumab) in combination with lenalidomide and dexamethasone as a first-line treatment for multiple myeloma patients who are ineligible for autologous stem cell transplant.
The U.S. patent office rejected a filing by Alvogen Pine Brook for a review challenging patents on Celgene’s blockbuster myeloma drug Revlimid.
Shares of Karyopharm Therapeutics crashed again after an advisory panel from the U.S. Food and Drug Administration recommended delaying potential approval of the company’s experimental multiple myeloma treatment until additional data is available from an ongoing Phase III study.
GlaxoSmithKline Plc will actively look to buy early-stage assets and partner with companies, the drugmaker’s chief executive officer said.
Takeda Pharmaceutical started 2019 with a spate of cell therapy collaborations designed to advance the company’s novel immuno-oncology portfolio. The three collaborations will accelerate the discovery of next-generation cancer immunotherapies.
Bristol-Myers Squibb Co. will buy Celgene Corp. for about $74 billion, creating one of the largest pharmaceutical companies and combining two significant cancer medicine businesses.
GlaxoSmithKline agreed to buy U.S. cancer specialist Tesaro for $5.1 billion, a costly investment to rebuild the pharma business by new Chief Executive Emma Walmsley that unnerved investors.
Denmark-based Genmab released top-line data from the Phase III MAIA clinical trial of Darzalex (daratumumab), a drug licensed to Johnson & Johnson’s Janssen.
A single leukemia cell inadvertently got mixed in with a batch of a patient’s immune cells that were being manufactured into a CAR-T cell therapy and it acquired resistance to the treatment with deadly results, University of Pennsylvania researchers reported.