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Number of results: 2699
Date Compound Product name Company Disease Action mechanism Type of Information
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
2017-06-22 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 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 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
2017-06-22 glecaprevir/pibrentasvir Maviret® Abbvie (USA - IL) chronic hepatitis C virus (HCV) infection in adults direct-acting antiviral agent/NS3/4A protease inhibitor/nonstructural protein 5A (NS5A) inhibitor. Maviret® is a fixed dose combination  of two direct acting-antivirals (DAA), glecaprevir… Positive opinion for the granting of a Market Authorisation in the EU
2017-06-12 bictegravir, emtricitabine, tenofovir alafenamide BIC/FTC/TAF (bictegravir (50 mg) and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) Gilead Sciences (USA - CA) HIV-1 infection in adults integrase inhibitor. Bictegravir is a HIV-1 integrase strand transfer inhibitor (INSTI). Submission of a Market Application in the US
2017-06-08 humanized monoclonal immunoglobulin G1 antibody directed against human CD19 conjugated to SG3199 through a protease cleavable valine-alanine linker ADCT-402 ADC Therapeutics (Switzerland) mantle cell lymphoma antibody drug conjugate. ADCT-402 is a novel antibody-drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19,… Granting of the orphan status in the US
2017-06-08 humanized monoclonal immunoglobulin G1 antibody directed against human CD19 conjugated to SG3199 through a protease cleavable valine-alanine linker ADCT-402 ADC Therapeutics (Switzerland) diffuse large B-cell lymphoma antibody drug conjugate. ADCT-402 is an antibody drug conjugate composed of a humanized monoclonal antibody that binds to human CD19, conjugated… Granting of the orphan status in the US
2017-06-07 plecanatide Trulance™ Synergy Pharmaceuticals (USA - NY) chronic idiopathic constipation (CIC) irritable bowel syndrome with constipation (IBS-C) peptide/oral guanylate cyclase C agonist.  Plecanatide is an analogue of uroguanylin, with the exception of a single amino acid. Uroguanylin… Acceptation for review of a sNDA
2017-06-06 nilotinib Tasigna® Novartis (Switzerland) Philadelphia-chromosome-positive chronic myelogenous leukaemia (CML) tyrosine kinase inhibitor. Tasigna® (nilotinib) is an orally available signal transduction inhibitor of the Bcr-Abl kinase, c-kit and Platelet Derived… Granting of a Market Authorisation in the EU
2017-06-02 nivolumab Opdivo® BMS (USA - NY) locally advanced unresectable or metastatic urothelial carcinoma (mUC) monoclonal antibody/immune chekcpoint inhibitor. Nivolumab is a fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed… Granting of a Market Authorisation in the EU
2017-06-01 cerliponase alfa Brineura™ - BMN 190 BioMarin Pharmaceutical (USA - CA) late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), a form of Batten disease enzyme replacement therapy. Cerliponase alfa is a recombinant human tripeptidyl peptidase 1 (rhTPP1). This enzyme replacement therapy is designed to restore TPP1… Granting of a Market Authorisation in the EU
2017-05-31 cetirizine Zerviate® - AC-170 NicOx (France) ocular itching associated with allergic conjunctivitis antihistamine. AC-170 is a topical ocular formulation of the second-generation histamine H1-receptor antagonist cetirizine. AC-170 has been developed for the treatment of ocular… Granting of a Market Authorisation in the US
2017-05-31 adalimumab biosimilar version of Humira® (adalimumab) Sandoz (Switzerland) plaque psoriasis, rheumatoid arthritis, axial spondyloarthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, polyarticular juvenile idiopathic arthritis, active enthesitis-related arthritis, hidradenitis suppurativa, non-infectious uveitis biosimilar/monoclonal antibody/TNF alpha inhibitor. Adalimumab is a monoclonal antibody that binds specifically to TNF alpha and blocks its interaction with  cell… Submission of a Market Application in the EU
2017-05-31 infliximab biosimilar version of infliximab (Remicade®) Sandoz (Switzerland) ulcerative colitis, Crohn's disease, psoriasis, ankylosing spondylitis, psoriatic arthritis, juvenile idiopathic arthritis, rheumatoid arthritis biosimilar/monoclonal antibody/TNF alpha inhibitor.   Submission of a Market Application in the EU
2017-05-30 nusinersen - antisense oligonucleotide targeted to the SMN2 gene Spinraza™ Biogen (USA - MA) Ionis Pharmaceuticals (USA - CA) spinal muscular atrophy (SMA) antisense oligonucleotide. The SMN protein is made by two genes, the SMN1 and SMN2 genes. Most patients with spinal muscular atrophy… Granting of a Market Authorisation in the EU
2017-05-22 fluciclovine (18F) Axumin™ Blue Earth Diagnostics (UK) detection of recurrence of prostate cancer amino acid analog/radiopharmaceutical. Fluciclovine (18F) injection ([18F] FACBC or anti1-amino-3-18F-fluorocyclobutane-1-carboxylic acid), is a synthetic amino acid PET imaging agent. It… Granting of a Market Authorisation in the EU
2017-05-18 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