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 25, 2016
BerGenBio presents new data
BerGenBio announces that preclinical data demonstrating that lead compound, BGB324, combined with immune checkpoint inhibitors has the potential to synergistically improve treatment of human cancers, has been presented at the American Association of Cancer Research Annual Meeting (AACR), April 16-20, 2016 in New Orleans, Louisiana. BGB324 is a first-in-class, highly selective, orally bioavailable small molecule […]
Drug Development Pharma - April 22, 2016
AZ launches integrated genomics approach
AstraZeneca and its global biologics research and development arm, MedImmune, has announced an integrated genomics initiative to transform drug discovery and development across its entire research and development pipeline. The initiative involves for example a new collaboration with the Institute for Molecular Medicine in Finland. The initiative includes new collaborations with Human Longevity, US, the Wellcome […]
Drug Development Pharma - April 3, 2016
FDA clears Hansa Medical’s IND application for IdeS in kidney transplantation
Hansa Medical announces that the US Food and Drug Administration (FDA) has completed the safety review of the company’s Investigational New Drug application (IND) and has concluded that the proposed clinical investigation can proceed. This enables Hansa Medical to start a clinical study to primarily evaluate IdeS’ efficacy in making highly sensitized kidney patients with […]
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 […]
Drug Development Pharma - March 8, 2016
MedImmune receives fast track designation
AstraZeneca’s global biologics research and development arm, MedImmune, has received Fast Track designation from the US Food and Drug Administration (FDA) for its investigational human monoclonal antibody (mAb), MEDI8852, for the treatment of patients hospitalised with Type A strain influenza. The FDA’s Fast Track programme is designed to expedite the development and review of drugs […]
