AstraZeneca said the FDA has accepted a supplemental New Drug Application for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor with clinical activity against central nervous system metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations).
Janssen Biotech Inc. said FDA has granted priority review designation for the New Drug Application for apalutamide, an investigational, next-generation oral androgen receptor inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer. Currently, there are no FDA-approved treatments for patients with non-metastatic CRPC.
Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson, said that it has entered into a worldwide collaboration and license agreement with Legend Biotech USA Inc. and Legend Biotech Ireland Limited, subsidiaries of Genscript Biotech Corp., to develop, manufacture and commercialize a chimeric antigen receptor T-cell drug candidate, LCAR-B38M, which specifically targets the B-cell maturation antigen. LCAR-B38M is currently accepted for review by the China Food and Drug Administration and in the planning phase of clinical studies in the United States for multiple myeloma.
ABILITY PHARMACEUTICALS of Barcelona, Spain, received orphan-drug designation from FDA for ABTL0812, for the treatment of pancreatic cancer. This regulatory milestone comes after the ODD in the pediatric cancer neuroblastoma granted by EMA and FDA in 2015. In preclinical studies, ABTL0812 have shown efficacy in pancreatic cancer as single agent and synergistic effect (by 8... […]
NINTEDANIB was granted orphan drug designation for the treatment of mesothelioma. The agent is sponsored by Boehringer Ingelheim Nintedanib is an oral triple angiokinase inhibitor which simultaneously inhibits vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR 1-3) signaling pathways. These three different angiokinase receptors, which... […]
Fate Therapeutics Inc. said that IND-enabling production of FT500 has commenced at University of Minnesota, Molecular and Cellular Therapeutics.
NOVOGENE, a commercial provider of genomic services, AITbiotech Pte Ltd, a Singapore biotechnology company, and the Genome Institute of Singapore announced that NovogeneAIT Genomics Singapore–a new joint venture between Novogene and AITbiotech–will establish a joint whole genome sequencing center at Biopolis, Singapore. The new center will provide Illumina HiSeq X based whole genome sequencing and […]
AMGEN and Allergan plc submitted a Marketing Authorization Application to the European Medicines Agency for ABP 215, a biosimilar candidate to Avastin (bevacizumab). The companies said they this submission is the first bevacizumab biosimilar application submitted to the EMA. ABP 215 is a biosimilar candidate to bevacizumab, a recombinant immunoglobulin G1 monoclonal antibody that binds […]
ABBVIE said the European Commission granted conditional marketing authorization for Venclyxto (venetoclax) monotherapy for the treatment of chronic lymphocytic leukaemia in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and for the treatment of CLL in the absence of 17p […]
Genentech, a member of the Roche Group said the FDA has granted full approval for Avastin (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy.
