Drug Development Pharma - May 24, 2016
Genmab’s Darzalex approved in Europe
Genmab has announced 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 and […]
Pharma Business - May 11, 2016
Genmab’s quarterly report
Genmab has announced their financial results for the first quarter of 2016 including a rapid progress in the development of daratumumab with Janssen. Net Sales of DARZALEX (daratumumab) by Janssen for the first quarter of 2016 were USD 101.9 million, resulting in royalty income of DKK 83 million. The company also announced positive interim result in […]
Drug Development Pharma - May 10, 2016
Ofatumumab treatment accepted for priority review by FDA
Genmab has announced that the U.S. Food and Drug Administration (FDA) granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). The application was submitted to the FDA by Novartis in […]
Drug Development Pharma - April 1, 2016
CHMP issues positive opinion recommending DARZALEX
Genmab announces that the Committee for Medicinal Products (CHMP) for Human Use of the European Medicines Agency (EMA) has issued a positive opinion recommending the grant of a conditional marketing authorization for DARZALEX (daratumumab) in the European Union. The recommendation is for the use of DARZALEX as monotherapy for the treatment of adult patients with […]
Clinical Trials - March 22, 2016
Genmab announces studies of daratumumab
Genmab announces that daratumumab will be investigated in early stage clinical studies in combination with atezolizumab (anti-PD-L1 antibody), in a solid tumor and multiple myeloma. The studies will be conducted under a clinical trial collaboration agreement between Genmab’s licensing partner for daratumumab, Janssen Biotech, Inc., and Genentech, a member of the Roche Group. Atezolizumab is […]
Acquisition - March 10, 2016
Genmab achieves second milestone
Genmab has reached a USD 5 million milestone in its daratumumab collaboration with Janssen Biotech, Inc. (Janssen). This is the second milestone payment triggered by progress in the ongoing Phase II study (“Carina” LYM2001) of daratumumab in NHL. The study evaluates daratumumab monotherapy in three different types of NHL, diffuse large B-cell lymphoma (DLBCL), follicular […]
