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Number of results: 2814
Date Compound Product name Company Disease Action mechanism Type of Information
2017-12-13 TK cell therapy Zalmoxis® - TK cell therapy MolMed (Italy) adjunctive treatment in hematopoietic stem cell transplantation (HSCT) for patients affected by high risk leukaemia cell therapy. Zalmoxis® is a cell therapy product, based on the use of genetically engineered donor T cells with a… Granting of a Market Authorisation in the EU
2017-12-11 3-pentylbenzenacetic acid sodium salt PBI-4050 - 3-pentylbenzenacetic acid sodium salt ProMetic Life Sciences (Canada)
  • idiopathic pulmonary fibrosis
antifibrotic agent Granting of a Fast Track status
2017-12-11 insulin lispro Insulin lispro Sanofi/Admelog® Sanofi (France)
  • type 1 diabetes mellitus
  • type 2 diabetes mellitus
biosimilar/insulin analog.  Insulin lispro is a fast-acting insulin analogue which is absorbed more rapidly by the body and can therefore… Granting of a Market Authorisation in the US
2017-11-27 genetically modified adeno-associated viral vector serotype 9 expressing shRNA as well as a codon-optimised shRNA-insensitive wildtype PABPN1 BB-301 - genetically modified adeno-associated viral vector serotype 9 expressing shRNA as well as a codon-optimised shRNA-insensitive wildtype PABPN1 Clinipace (Germany) Benitec BioPharma (Australia) oculopharyngeal muscular dystrophy gene therapy. BB-301 is a single vector system which uses DNA directed RNA interference (ddRNAi) to silence expression of the mutant… Granting of the orphan status in the EU
2017-11-16 autologous T-lymphocytes transduced with anti-BCMA02 CAR lentiviral vector encoding a chimeric antigen receptor (CAR) specific for the human B cell maturation antigen bb2121 anti-BCMA CAR T cells - autologous T-lymphocytes transduced with anti-BCMA02 CAR lentiviral vector encoding a chimeric antigen receptor (CAR) specific for the human B cell maturation antigen Celgene (USA - NJ) Bluebird bio (USA - MA) multiple myeloma cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy   Granting of the Breakthrough Therapy status
2017-11-16 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 mimics coagulation factor VIII. It is currently investigated as a therapy for people… Granting of a Market Authorisation in the US
2017-11-15 vestronidase alfa-vjbk Mepsevii® Ultragenyx Pharmaceutical (USA - CA) mucopolysaccharidosis 7 (MPS 7, Sly syndrome) enzyme replacement therapy. Mucopolysaccharidosis 7 is caused by a deficiency of the lysosomal enzyme beta-glucuronidase, which is required for the breakdown… Granting of a Market Authorisation in the US
2017-11-14 benralizumab Fasenra® AstraZeneca (UK)
  • add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype
  • add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting ?-agonists
monoclonal antibody. Benralizumab is a monoclonal antibody directed at the alpha subunit of the interleukin-5 receptor (IL-5Ralpha) that depletes eosinophils, a… Granting of a Market Authorisation in the US
2017-11-13 revefenacin revefenacin (TD-4208) Mylan (USA - PA) Theravance (UK) chronic obstructive pulmonary disease (COPD) long-acting muscarinic antagonist (LAMA). Revefenacin is an investigational long-acting muscarinic antagonist (LAMA) and a proposed once-daily, nebulized bronchodilator in development… Submission of a Market Application in the US
2017-11-09 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… Granting of a Market Authorisation in the EU
2017-11-09 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. It is based on Advate®, . Through… Positive opinion for the granting of a Market Authorisation in the EU
2017-11-09 dasatinib Sprycel® BMS (USA - NY)
  • pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML)
tyrosine kinase inhibitor. Dasatinib is an oral dual BCR/ABL and Src family tyrosine kinase inhibitor approved for use in patients with… Granting of a Market Authorisation in the US
2017-11-06 vemurafenib Zelboraf® Roche (Switzerland) kinase inhibitor. Vemurafenib is a BRAF-inhibitor and it is designed to selectively target and inhibit a mutated form of the… Granting of a Market Authorisation in the US
2017-10-19 CRISPR technology CRISPR technology Merck KGaA (Germany) gene editing technology CRISPR genome-editing technology allows the precise modification of chromosomes in living cells. It is advancing treatment options for… Granting of a patent
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
2017-10-16 ofranergene obadenovec VB-111 VBL Therapeutics (Israel) ovarian cancer gene therapy. VB-111 is a dual-action, anti-angiogenic and Vascular Disruptive Agent (VDA) that utilizes VTS™, VBL’s proprietary platform technology for… Granting of the orphan status in the EU
2017-10-13 pegaspargase - pegylated L-asparaginase Oncaspar® Baxalta (USA - IL) now Shire (UK - USA) acute lymphoblastic leukaemia (ALL) enzyme/antineoplastic agent. Oncaspar® (pegaspargase) is composed of E. coli derived L-asparaginase, which is synthetically modified by covalently conjugating units of… Positive opinion for the granting of a Market Authorisation in the EU
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