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Number of results: 2851
Date Compound Product name Company Disease Action mechanism Type of Information
2018-03-29 sotagliflozin sotagliflozin (LX4211) Sanofi (France) type 1 diabetes SGLT1 inhibitor/SGLT2 inhibitor. Sotagliflozin is an investigational new oral dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT1 and SGLT2)… Acceptation for review of a NDA
2018-03-22 rucaparib Rubraca® Clovis Oncology UK - Clovis Oncology (USA) ovarian cancer enzyme inhibitor/PARP inhibitor. Rucaparib is an orally-available, small molecule PARP 1 (poly ADP-ribose polymerase), PARP2 and PARP3 inhibitor being developed for… Positive opinion for the granting of a Market Authorisation in the EU
2018-03-22 dolutegravir and rilpivirine Juluca® (dolutegravir and rilpivirine) ViiV Healthcare (UK - USA) maintenance treatment of HIV-1 infection integrase inhibitor/non-nucleoside reverse transcriptase inhibitor. Dolutegravir is an investigational integrase inhibitor (INI). Integrase inhibitors block HIV replication by  preventing the viral… Positive opinion for the granting of a Market Authorisation in the EU
2018-03-22 plitidepsin Aplidin® Pharmamar (Spain) relapsed/refractory multiple myeloma depsipeptide derivative. Plitidepsin is an investigational anticancer agent of marine origin, originally obtained from the tunicate Aplidium albicans. It specifically binds to… Negative opinion for the granting of a Market Authorisation in the EU
2018-03-22 abaloparatide Eladynos®/Tymlos® Radius Health (USA - MA) postmenopausal women with osteoporosis at high risk for fracture peptide. Abaloparatide-SC is a novel 34–amino acid peptide  similar to part of the human parathyroid hormone. It has been created to… Negative opinion for the granting of a Market Authorisation in the EU
2018-03-22 biosimilar version of infliximab (Remicade®) Zessly® Sandoz (Switzerland)
  • ulcerative colitis, Crohn's disease, psoriasis, ankylosing spondylitis, psoriatic arthritis, juvenile idiopathic arthritis, rheumatoid arthritis
biosimilar/monoclonal antibody/TNF alpha inhibitor. Infliximab is a tumour necrosis factor alpha (TNF-?) inhibitor. This chimeric human murine monoclonal antibody binds with high… Positive opinion for the granting of a Market Authorisation in the EU
2018-03-22 biosimilar version of trastuzumab - Herceptin® Kanjinti® - ABP 980 Amgen (USA - CA) Allergan (Ireland) breast cancer, gastric cancer biosimilar/monoclonal antibody. ABP 980 is being developed as a biosimilar to trastuzumab (Herceptin®), a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa… Positive opinion for the granting of a Market Authorisation in the EU
2018-03-22 evolocumab Repatha® Amgen (USA - CA)
  • adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C), patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C
  • established atherosclerotic cardiovascular disease
monoclonal antibody/RNAi/PCSK9 inhibitor. Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).PCSK9 is a… Positive opinion for the granting of a Market Authorisation in the EU
2018-03-22 cabozantinib Cabometyx® Exelixis (USA - CA) Ipsen (France) previously untreated advanced renal cell carcinoma tyrosine kinase inhibitor. Cabozantinib is a kinase inhibitor that blocks abnormal kinase proteins involved in the development and growth of medullary cancer… Refusal of a Market Autorisation in the EU
2018-03-22 betrixaban Bevyxxa®(US)/Dexxience® (UE) Portola Pharmaceuticals (USA - CA) prevention of venous thromboembolism (VTE) anticoagulant agent/oral direct Factor Xa inhibitor . Betrixaban is an oral, once-daily Factor Xa inhibitor anticoagulant. It blocks this protein which… Negative opinion for the granting of a Market Authorisation in the EU
2018-03-08 delafloxacin Baxdela® (US)/Quofenix®(UE) Melinta Therapeutics (USA - CT)
  • acute bacterial skin and skin structure infections (ABSSSI)
antibiotic. Delafloxacin is an anionic fluoroquinolone antibiotic currently in Phase 3 clinical development for hospital-treated skin infections, known as acute bacterial… Submission of a Market Application in the EU
2018-03-05 prucalopride Resolor® - SHP555 Shire (UK - USA)
  •  symptomatic treatment of chronic constipation in patients whom laxatives fail to provide adequate relief
  • chronic idiopathic constipation
5-HT4 receptor agonist. Prucalopride is a selective, high-affinity 5-HT4 receptor agonist with gastrointestinal prokinetic effects. It binds to and stimulates 5-HT4… Acceptation for review of a NDA
2018-02-28 calaspargase pegol calaspargase pegol (Cal-PEG - SHP663) Shire (UK - USA) acute lymphoblastic leukemia (ALL) enzyme/protein. Calaspargase pegol is an intravenous formulation containing E. coli-derived L-asparaginase II conjugated with succinimidyl carbonate monomethoxypolyethylene glycol (SC-PEG) . L-asparaginase hydrolyzes… Acceptation for review of a NDA
2018-02-27 monoclonal antibody inhibitor of plasma kallikrein - recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein lanadelumab (DX-2930 - SHP643) Dyax (USA - MA), now Shire (UK - USA) hereditary angioedema (HAE) monoclonal antibody. DX-2930 is a novel, fully human monoclonal antibody inhibitor of plasma kallikrein (pKal) and is being developed by… Granting of a Fast Track status
2018-02-26 abemaciclib Verzenio™ - abemaciclib (LY2835219) Eli Lilly (USA -IN)
  • refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer
cell cycle inhibitor/cyclin dependant kinase inhibitor. Abemaciclib (LY2835219) is a cell cycle inhibitor, designed to block the growth of cancer… Granting of a Market Authorisation in the US
2018-02-23 emicizumab (ACE910 - anti-factor IXa x anti-factor X humanized bispecific antibody) Hemlibra® Chugai Pharmaceutical (Japan) Roche (Switzerland) hemophilia A with factor VIII inhibitors  in adult and pediatric patients bispecific antibody. Emicizumab is a bispecific antibody that works by mimicking the coagulation function of factor VIII. Emicizumab was designated as a… Granting of a Market Authorisation in the EU
2018-02-22 neratinib Nerlynx® (PB272) Puma Biotechnology (USA - CA)
  • extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with trastuzumab (Herceptin®)-based adjuvant therapy
kinase inhibitor/tyrosine kinase inhibitor. PB272 (neratinib) is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth… Refusal of a Market Autorisation in the EU
2018-02-20 Portola Pharmaceuticals (USA - CA) prevention of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness with risk factors for VTE anticoagulant agent/oral direct Factor Xa inhibitor . Betrixaban is an oral, once-daily Factor Xa inhibitor anticoagulant. It is an FDA-designated Fast… Negative opinion for the granting of a Market Authorisation in the EU
2018-02-19 burosumab -recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23 Crysvita® - burosumab (KRN23) Ultragenyx Pharmaceutical (USA - CA) Kyowa Hakko Kirin (Japan) X- linked hypophosphataemia monoclonal antibody. KRN23 is an investigational recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Hakko Kirin, against the phosphaturic… Granting of a Market Authorisation in the EU
2018-02-16 durvalumab Imfinzi® AstraZeneca (UK)
  • locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy
monoclonal antibody/immune checkpoint inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals… Granting of the Breakthrough Therapy status