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Number of results: 2737
Date Compound Product name Company Disease Action mechanism Type of Information
2017-06-30 PEGylated recombinant phenylalanine ammonia lyase enzyme pegvaliase Biomarin Pharmaceutical (USA - CA) phenylketonuria enzyme replacement therapy. PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase or ‘PAL’, pegvaliase) is an investigational drug that substitutes for the PAH enzyme… Submission of a Market Application in the US
2017-06-30 polatuzumab vedotin polatuzumab vedotin Roche (Switzerland) relapsed or refractory diffuse large B cell lymphoma (DLBCL) antibody drug conjugate. Polatuzumab vedotin (Anti-CD79b, DCDS4501A, RG7596) is an antibody drug conjugate (ADC) composed of a monoclonal antibody directed… Granting of a Fast Track status
2017-06-29 panitumumab Vectibix® Amgen (USA - CA)
adult patients with wild-type RAS metastatic colorectal cancer (mCRC):
• in first-line in combination with FOLFOX
• in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan)
• as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Vectibix® is a fully human anti-EGFR antibody. Granting of a Market Authorisation in the US
2017-06-29 Extended RAS Pane Illumina (USA - CA) colorectal cancer companion diagnostic Granting of a Market Authorisation in the US
2017-06-29 ceritinib Zykadia® (LDK378) Novartis (Switzerland) treatment of patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who had progressed during treatment with, or were intolerant to, crizotinib - first-line treatment of patients with advanced NSCLC whose tumors are ALK+ kinase inhibitor/tyrosine kinase inhibitor. LDK378 (ceritinib) is a highly selective inhibitor of anaplastic lymphoma kinase (ALK) that blocks proteins that promote… Granting of a Market Authorisation in the EU
2017-06-28 recombinant adeno-associated viral vector serotype 6 encoding the B-domain-deleted CB 2679d/ISU304 Catalyst Biosciences (USA - CA)/Voisin Consulting (France) hemophilia B coagulation factor/protein. CB 2679d/ISU304 is a next-generation coagulation Factor IX variant. It has exhibited enhanced procoagulant activity, improved efficacy in… Granting of the orphan status in the EU
2017-06-27 pirfenidone Esbriet® Intermune (USA - CA) Genentech, a member of the Roche Group (USA - Switzerland) mild to moderate idiopathic pulmonary fibrosis (IPF) Esbriet® is an orally active, small molecule drug that inhibits the synthesis of TGF-beta, a chemical mediator that controls many… Granting of a Market Authorisation in the EU
2017-06-27 etanercept biosimilar Erelzi® - etanercept biosimilar Sandoz (Switzerland) rheumatoid arthritis, psoriasis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, paediatric plaque psoriasis TNF alpha inhibitor/biosimilar. Etanercept is a competitive inhibitor of TNF, it binds to cell surface TNFR, preventing TNF mediated cellular responses… Granting of a Market Authorisation in the EU
2017-06-27 sarilumab Kevzara®(sarilumab - REGN88/SAR153191) Sanofi (France) Regeneron Pharmaceutical (USA - NY) rheumatoid arthritis monoclonal antibody. Sarilumab (REGN88/SAR153191) is a fully human monoclonal antibody directed against the alpha subunit of the IL-6 receptor complex… Granting of a Market Authorisation in the EU
2017-06-26 regorafenib Stivarga® Bayer Healthcare (Germany) hepatocellular carcinoma multi-kinase inhibitor. Stivarga® (regorafenib) is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and… Granting of a Market Authorisation in Japan
2017-06-23 masitinib Masipro® AB Science (France) severe systemic mastocytosis unresponsive to optimal symptomatic treatment kinase inhibitor/tyrosine kinase inhibitor. Masitinib is a tyrosine kinase inhibitor that targets mast cells, important cells for immunity, as well as… Negative opinion for the granting of a Market Authorisation in the EU
2017-06-23 human IgG1 monoclonal antibody specific for human interleukin-1 Xilonix® human IgG1 monoclonal antibody specific for human interleukin-1 XBiotech (USA - TX) debilitating symptoms of advanced colorectal cancer monoclonal antibody. Negative opinion for the granting of a Market Authorisation in the EU
2017-06-22 cladribine Mavenclad® Merck KGaA (Germany) relapsing-remitting multiple sclerosis nucleoside analog. Cladribine (2-chlorodeoxyadenosine [2-CdA]) is a purine analog. This synthetic anti-cancer agent that also suppresses the immune system. Cladribine inhibits… Positive opinion for the granting of a Market Authorisation in the EU
2017-06-22 liraglutide Victoza® Novo Nordisk (Denmark) type 2 diabetes Glucagon-like Peptide 1 (GLP-1) analogue. This human Glucagon-Like Peptide-1 (GLP-1) analogue works by stimulating the release of insulin from the pancreatic beta… Positive opinion for the granting of a Market Authorisation in the EU
2017-06-22 eculizumab Soliris® Alexion Europe (Switzerland) myasthenia gravis, refractory generalized myasthenia gravis  in patients who are anti-acetylcholine receptor (AChR) antibody-positive monoclonal antibody. Eculizumab is a recombinant humanized monoclonal IgG2/4 antibody that specifically binds to the complement protein C5, inhibiting its… Positive opinion for the granting of a Market Authorisation in the EU
2017-06-22 adalimumab Imraldi® - SB5 - biosimilar version of Humira® Samsung Bioepis (Republic of Korea) Biogen (USA - CA) rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, uveitis. biosimilar/monoclonal antibody/TNF alpha inhibitor. SB5  is a biosimilar version of Humira® (adalimumab), a tumour necrosis factor alpha (TNF?) inhibitor. Adalimumab binds to… Positive opinion for the granting of a Market Authorisation in the EU
2017-06-22 ribociclib in combination with letrozole Kisqali® in combination with letrozole Novartis (Switzerland) HR+/HER2- advanced breast cancer kinase inhibitor/cyclin dependent kinase inhibitor. Kisqali® (LEE011 - ribociclib) is a selective cyclin dependent kinase inhibitor, a new class of drugs that… Positive opinion for the granting of a Market Authorisation in the EU
2017-06-22 tivozanib - N-{2-Chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-N´-(5-methyl-3-isoxazolyl) urea hydrochloride monohydrate Fotivda® Aveo Oncology (USA - MA) Eusa Pharma (UK) first-line treatment of advanced renal cell carcinoma (RCC) kinase inhibitor/tyrosine kinase inhibitor. Tivozanib is an oral, potent, selective inhibitor of vascular endothelial growth factor tyrosine kinase inhibitor (VEGF TKI) with… Positive opinion for the granting of a Market Authorisation in the EU
2017-06-22 anamorelin Adlumiz® Helsinn Group (Switzerland) anorexia, cachexia, or unintended weight loss in non-small cell lung cancer (NSCLC) patients peptide. Anamorelin HCl is an orally administered ghrelin receptor agonist. Ghrelin is an endogenous peptide primarily secreted by the stomach. Upon binding… Negative opinion for the granting of a Market Authorisation in the EU
2017-06-22 human C1 esterase Inhibitor Haegarda® CSL (Australia) prevention of hereditary angioedema (HAE) attacks in adolescent and adult patients protein Haegarda® is a human plasma-derived, purified, pasteurized, lyophilized (freeze-dried) concentrate prepared from large pools of human plasma from U.S. donors. This self-administered,… Granting of a Market Authorisation in the US