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Number of results: 2804
Date Compound Product name Company Disease Action mechanism Type of Information
2017-10-18 autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor Yescarta™ - axicabtagene ciloleucel - KTE-C19) Kite Pharma, a Gilead company (USA - CA)
  • relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT), diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL)
cell therapy/immunotherapy product/CAR-T cell therapy. Axicabtagene ciloleucel (KTE-C19) is Kite Pharma's lead product candidate in which a patient's T cells… Granting of a Market Authorisation in the US
2017-10-04 pegfilgrastim - biosimilar version of Neulasta® B12019 Cinfa Biotech (Spain) chemotherapy induced neutropenia protein/biosimilar. B12019, a biosimilar version of Neulasta® (pegfilgrastim), a pegylated form of the human granulocyte colony stimulating factor (G-CSF) analogue filgrastim. This granulocyte… Submission of a Market Application in the EU
2017-10-02 ceftazidime-avibactam Avycaz®/Zavicefta® AstraZeneca (UK) - Forest Laboratories (USA - NJ), an Actavis' subsidiary (Ireland), now Allergan (Ireland)
  • complicated intra-abdominal infections (cIAI), in combination with metronidazole
  • complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis)
  • hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)
 
antibiotic/cephalosporine/beta-lactamase inhibitor. Avycaz® consists of a cephalosporin (ceftazidime), an established treatment for serious bacterial infections, and a next generation non-beta lactam beta-lactamase… Acceptation for review of a sNDA
2017-09-29 insulin aspart FIAsp® (faster-acting formulation of insulin aspart NovoRapid®) (NN1218) Novo Nordisk (Denmark) diabetes insulin analog. Faster-acting insulin aspart is a mealtime insulin for control of postprandial glucose excursions in type 1 and type… Granting of a Market Authorisation in the US
2017-09-28 remimazolam remimazolam Paion (Germany) benzodiazepine derivative. Remimazolam is a short-acting general anaesthetic/sedative. Sedatives are used, for example, in endoscopic procedures such as colonoscopies. After… Granting of a patent
2017-09-27 adeno-associated viral vector serotype 5 encoding a microRNA targeted to human huntingtin gene AMT-130 Uniqure (The Netherlands) Huntington's disease gene therapy. AMT-130 consists of an AAV5 vector carrying a DNA cassette encoding artificial micro-RNA (miHTT) that silences the huntingtin gene. Granting of the orphan status in the US
2017-09-22 cariprazine Vraylar® (US)/Reagila® (EU) Allergan (Ireland) Gedeon Richter (Hungary) Recordati (Italy)
  • schizophrenia
  • manic or mixed episodes associated with bipolar I disorder in adults
  • maintenance of efficacy in adults with schizophrenia
dopamine D3 receptor partial agonist. Cariprazine has been discovered by researchers at Gedeon Richter. This orally active, potent dopamine D3-preferring D3/D2… Refusal of a Market Autorisation in the US
2017-09-22 sirukumab Plivensia™ Janssen-Cilag International, a J&J company (USA - NJ) GSK (UK) moderately to severely active rheumatoid arthritis monoclonal antibody. Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high affinity and specificity for binding to… Refusal of a Market Autorisation in the US
2017-09-22 alpha-1 proteinase inhibitor Prolastin®-C Liquid Grifols (Spain) alpha-1 antitrypsin deficiency enzyme replacement therapy. Prolastin®-C Liquid is the first liquid formulation of an alpha-1 antitrypsin deficiency replacement therapy manufactured in the U.S.… Granting of a Market Authorisation in the US
2017-09-19 telotristat etiprate - (S)-ethyl2-amino-3-(4-(2-amino-6-((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate Xermelo® (telotristat etiprate - LX1032) Ipsen (France) Lexicon Pharmaceuticals (USA - TX)
  • carcinoid syndrome caused by neuroendocrine tumors
  • carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy
enzyme inhibitor. Telotristat etiprate is an oral, small-molecule inhibitor of tryptophan hydroxylase (TPH) that reduces peripheral serotonin production without affecting brain… Granting of a Market Authorisation in the EU
2017-09-18 fluticasone furoate/umeclidinium/vilanterol Trelegy Ellipta® GSK (UK) maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting ?2-agonist corticosteroid/long-acting beta2-agonist (LABA)long-acting muscarinic antagonist (LAMA). This treatment combines an inhaled corticosteroid (fluticasone furoate); a long-acting muscarinic antagonist (umeclidinium); and… Granting of a Market Authorisation in the US
2017-09-15 idebenone Raxone®/Catena® Santhera Pharmaceuticals (Switzerland) Duchenne Muscular Dystrophy and other muscular dystrophies benzoquinone analog/quinone. Raxone® (idebenone), a synthetic short-chain benzoquinone and a cofactor for the enzyme NAD(P)H:quinone oxidoreductase (NQO1), is capable of… Negative opinion for the granting of a Market Authorisation in the EU
2017-09-15 brivaracetam Briviact® UCB (Belgium) partial-onset (focal) seizures in patients 16 years and older with epilepsy antiepileptic agent. Brivaracetam is a novel high-affinity synaptic vesicle protein 2A (SV2A) ligand. Its anticonvulsant activity is believed to be mediated mainly… Granting of a Market Authorisation in the US
2017-09-14 icatibant - synthetic decapeptide Firazyr® Shire (UK) acute attacks of hereditary angioedema (HAE) peptide. Icatibant is a specific bradykinin B2 receptor antagonist designed to block the effects of bradykinin, the key mediator of… Positive opinion for the granting of a Market Authorisation in the EU
2017-09-14 rivaroxaban Xarelto® Bayer Healthcare (Germany)
  • • prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) following an acute DVT in adults
  • •  extended prevention of recurrent venous thromboembolism
anticoagulant agent/oral direct Factor Xa inhibitor Granting of a Market Authorisation in the EU
2017-09-14 rivaroxaban Xarelto® Bayer (Germany)
  • • treatment of pulmonary embolism and prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism
  • •  extended prevention of recurrent venous thromboembolism
anticoagulant agent/oral direct Factor Xa inhibitor Granting of a Market Authorisation in the EU
2017-09-14 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
2017-09-14 biosimilar version of trastuzumab Ontruzant® - SB3 Samsung Bioepis (Republic of Korea) early breast cancer, metastatic breast cancer, metastatic gastric cancer biosimilar/monoclonal antibody. Trastuzumab is a recombinant humanized monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER2). After binding… Positive opinion for the granting of a Market Authorisation in the EU
2017-09-14 elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg Stribild® Gilead Sciences (USA)
  • - HIV-1 infection in adults who are antiretroviral treatment-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild®
  • - HIV-1 infection in adolescents aged 12 to < 18 years weighing ? 35 kg who are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild® and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil fumarate
Stribild® contains four Gilead compounds in a complete once-daily, single tablet regimen: elvitegravir 150 mg; cobicistat 150 mg; emtricitabine 200… Granting of a Market Authorisation in the EU
2017-09-14 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… Positive opinion for the granting of a Market Authorisation in the EU