Clinical Trials - November 3, 2016
Genmab announces Phase III Study
Genmab announces that daratumumab (DARZALEX) will be investigated in a Phase III clinical study in combination with carfilzomib (KYPROLIS) and dexamethasone in patients with relapsed/refractory multiple myeloma. The study will be conducted under a master clinical trial collaboration and supply agreement between Genmab’s licensing partner for daratumumab, Janssen Biotech, Inc., and Onyx Pharmaceuticals, Inc., a […]
Drug Development Pharma - August 24, 2016
Genmab announces European Regulatory Submission
Genmab announced yesterday that Janssen Pharmaceutica has submitted a variation to the Marketing Authorization to the European Medicines Agency (EMA) seeking to broaden the existing marketing authorization for daratumumab (DARZALEX) to include treatment of adult patients with multiple myeloma who have received at least one prior therapy. The submission of the application triggers milestone payments […]
Drug Development Pharma - August 18, 2016
Genmab submits FDA application for Daratumumab
Genmab has announced that its licensing partner, Janssen Biotech, Inc. has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the use of daratumumab (DARZALEX) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who received at least one prior […]
Agreement - August 15, 2016
Genmab in new agreement
Genmab has entered an agreement to grant Gilead Sciences, an exclusive license and an option on a second exclusive license, to use the DuoBody technology platform to create and develop bispecific antibody candidates for a therapeutic program targeting HIV. Under the terms of the agreement, Genmab will receive an upfront payment of USD 5 million […]
Clinical Trials - June 2, 2016
Genmab anounce Phase III studies
Genmab A/S announces that its collaboration partner Novartis will start Phase III studies of the subcutaneous formulation of ofatumumab in relapsing multiple sclerosis (MS) with enrolment of patients expected to start in September 2016. The studies will compare the efficacy and safety of subcutaneous ofatumumab versus teriflunomide in patients with relapsing MS. Details of the […]
Pharma Business - May 25, 2016
Genmab’s Darzalex receives market authorization
Genmab A/S announces that the European Commission (EC) has granted a conditional marketing authorization for first-in-class CD38 antibody DARZALEX (daratumumab). The conditional approval is for the use of DARZALEX as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent […]
