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.
FDA approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of renal cell carcinoma returning after nephrectomy.
FDA approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene.
Tesaro Inc. said the European Commission has granted marketing authorization for Zejula (niraparib) as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.
G1 Therapeutics Inc. and AstraZeneca announced a collaboration to evaluate AstraZeneca's epidermal growth factor receptor tyrosine kinase inhibitor Tagrisso (osimertinib) in combination with G1's oral CDK4/6 inhibitor G1T38 for the treatment of EGFR mutation-positive non-small cell lung cancer.
