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Number of results: 2851
Date Compound Product name Company Disease Action mechanism Type of Information
2018-01-08 budesonide Jorveza® Dr Falk Pharma GmbH (Germany) eosinophilic oesophagitis  in adults corticosteroid. Budesonide is a locally acting corticosteroid which works primarily via binding to the glucocorticoid receptor. In the treatment of eosinophilic… Granting of a Market Authorisation in the EU
2018-01-08 rurioctocog alfa pegol Adynovate®/Adynovi® (EU) - BAX 855 Baxalta (USA - IL) now Shire (UK - USA) hemophilia A blood coagulation factor/protein. Adynovate®/BAX 855  is a full-length FVIII molecule pegylated recombinant factor VIII. BAX 855 is based on Advate® and… Granting of a Market Authorisation in the EU
2018-01-08 ocrelizumab Ocrevus™ Genentech, a member of Roche Group (USA - CA - Switzerland)
  • primary progressive multiple sclerosis (PPMS)
  • relapsing multiple sclerosis (RMS)
monoclonal antibody. Ocrelizumab is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells. CD20-positive B cells are a… Granting of a Market Authorisation in the EU
2018-01-08 romosozumab Evenity® Amgen (USA - CA) UCB (Belgium)
  • osteoporosis in postmenopausal women and men at increased risk of fracture
monoclonal antibody. Romosozumab (CDP7851/AMG 785) is a humanized monoclonal antibody that binds to and inhibits sclerostin, a protein secreted by bone cells… Submission of a Market Application in the EU
2018-01-08 hepatitis B vaccine Heplisav-B® Dynavax (USA - CA) immunization against hepatitis B vaccine. Heplisav-B® combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. In Phase… Product launch
2018-01-08 upadacitinib upadacitinib (ABT-494) Abbvie (USA - IL) atopic dermatitis JAK inhibitor/tyrosine kinase inhibitor. Upadacitinib is an investigational oral agent engineered to selectively inhibit JAK1, which plays an important role in… Granting of the Breakthrough Therapy status
2018-01-05 denosumab Xgeva® Amgen (USA - CA) prevention of skeletal-related event (SRE) in patients with multiple myeloma monoclonal antibody. Denosumab is a fully human monoclonal antibody that binds to RANK Ligand, a protein essential for the formation, function and… Granting of a Market Authorisation in the US
2018-01-04 maribavir maribavir (SHP620) Viropharma (USA), now Shire (UK - USA)
  • cytomegalovirus (CMV) disease in patients with impaired cell mediated immunity
  • cytomegalovirus infection and disease in transplant patients resistant or refractory to prior therapy
antiviral agent. Maribavir is a member of a new class of drugs called benzimidazole ribosides.  By inhibiting the CMV UL97… Granting of the Breakthrough Therapy status
2018-01-03 lifitegrast Xiidra™ Shire (UK-USA) dry eye disease integrin antagonist/LFA-1 antagonist. Lifitegrast, a small-molecule integrin antagonist, was designed in order to treat dry eye disease, and is a preservative-free… Granting of a Market Authorisation in Canada
2018-01-02 brentuximab vedotin Adcetris® Seattle Genetics (USA - WA), a wholly owned subsidiary of Takeda Pharmaceutical (Japan) antibody drug conjugate/monoclonal antibody. Adcetris® (brentuximab vedotin) is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker… Acceptation for review of a sNDA
2017-12-29 trastuzumab-dkst - biosimilar version of trastuzumab Ogivri® - Zedora® - MYL-1401O Mylan (USA - PA) Biocon (India) Libbs Farmaceutica (Brazil) HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer, HER2-positive advanced gastric cancer biosimilar/monoclonal antibody. MYL-1401O is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers.… Granting of a Market Authorisation in the US
2017-12-27 mercaptamine Procysbi® Raptor Pharmaceuticals Europe, now Horizon Pharma (Ireland) nephropathic cystinosis Procysbi® is a cystine depleting agent. It was engineered to bypass absorption in the stomach with an extended terminal half-life… Granting of a Market Authorisation in the US
2017-12-26 ivosidenib ivosidenib (AG-120) QRC Consultants (UK) - Agios Pharmaceuticals (USA - MA)
  • acute myeloid leukaemia
  • patients with relapsed or refractory acute myeloid leukemia (R/R AML) and an isocitrate dehydrogenase-1 (IDH1) mutation
enzyme inhibitor/isocitrate dehydrogenase inhibitor . AG-120 (ivosidenib) is a first-in-class, orally available, selective, potent inhibitor of the mutated IDH1 (Isocitrate dehydrogenase 1) protein, and… Submission of a Market Application in the US
2017-12-26 1,2:5,6-dianhydrogalactitol VAL-083 - 1,2:5,6-dianhydrogalactitol DelMar Pharmaceuticals (USA - CA) recurrent glioblastoma alkylating agent. VAL-083 (dianhydrogalactitol) is a bi-functional alkylating agent causing N7-guanine alkylation and inter-strand DNA crosslinks. VAL-083's cytotoxic activity is… Granting of a Fast Track status
2017-12-22 trametinib in combination with dabrafenib trametinib (Mekinist®) in combination with dabrafenib (Tafinlar®) Novartis (Switzerland)
  • unresectable or metastatic melanoma with a BRAF V600 mutation
  • adjuvant treatment of patients with stage III melanoma with BRAF V600E or V600K mutations
kinase inhibitor/RAF kinase inhibitor/MEK (MAP kinase) inhibitor. Dabrafenib is a selective inhibitor of BRAF protein kinase carrying V600E mutation. This orally bioavailable inhibitor… Acceptation for review of a sNDA
2017-12-22 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
2017-12-22 andexanet alfa AndexXa®(US)/ IndexXa™ (EU) Portola Pharmaceuticals (USA - CA)
  • reversing of the anticoagulant effect of direct or indirect factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event or who require urgent or emergent surgery
protein. Andexanet alfa, an FDA-designated breakthrough therapy, is a first-in-class recombinant, modified Factor Xa molecule. It is being developed as… Acceptation for review of a NDA
2017-12-22 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 PAL enzyme… Acceptation for review of a NDA
2017-12-21 nivolumab Opdivo® BMS (USA - NY)
  • previously untreated patients with unresectable or metastatic melanoma
  • previously treated advanced melanoma
  • adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
monoclonal antibody. Nivolumab is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1)… Granting of a Market Authorisation in the US
2017-12-21 apalutamide apalutamide Janssen Biotech, a J&J company (USA - NJ) non-metastatic castration-resistant prostate cancer (CRPC) antiandrogen/androgen receptor blocker. Apalutamide is an investigational, next-generation oral androgen receptor inhibitor that inhibits the action of androgen in prostate… Submission of a Market Application in the US