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Number of results: 2842
Date Compound Product name Company Disease Action mechanism Type of Information
2017-12-20 pertuzumab Perjeta® Genentech, a member of the Roche Group (USA - Switzerland) Roche (Switzerland)
  • neoadjuvant treatment in people with HER2-positive early stage breast cancer
  • adjuvant (after surgery) treatment of HER2-positive early breast cancer at high risk of recurrence
monoclonal antibody. Pertuzumab is a humanized monoclonal antibody. It has been designed specifically to prevent the HER2 receptor from pairing… Granting of a Market Authorisation in the US
2017-12-20 solriamfetol solriamfetol (JZP-110) Jazz Pharmaceuticals (Ireland) excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA) dopamine and norepinephrine reuptake inhibitor (DNRI). JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in development for treatment… Submission of a Market Application in the US
2017-12-19 bosutinib Bosulif® Pfizer (USA - NY)
  • Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML)
  • patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)
kinase inhibitor. Bosulif® is intended for patients with chronic, accelerated or blast phase Philadelphia chromosome positive CML who are resistant… Granting of a Market Authorisation in the US
2017-12-19 adeno-associated viral vector type 2 expressing human recombinant retinal pigment epithelial 65KDa protein gene Luxturna™ ((voretigene neparvovec-rzyl - SPK-RPE65) Spark Therapeutics (USA - PA)
  • retinitis pigmentosa due to autosomal recessive RPE65 gene mutations/inherited retinal dystrophy due to biallelic RPE65 mutations
gene therapy. Voretigene neparvovec (SPK-RPE65) uses a neutralized virus as a vector, to transport a functional RPE65 gene into the affected… Granting of a Market Authorisation in the US
2017-12-19 software myPKFiT for Advate software Shire (UK - USA) hemophilia A software. myPKFiT for Advate software is intended for use by licensed healthcare professionals  who are familiar with hemophilia care. It can… Granting of a Market Authorisation in the US
2017-12-18 patisiran (ALN-TTR02) ALN-TTR02 Alnylam Pharmaceuticals (USA - MA) Sanofi (France)
  • transthyretin (TTR)-familial amyloid polyneuropathy (FAP)
  • hereditary transthyretin-mediated amyloidosis
RNAi. Patisiran is an investigational RNAi therapeutic targeting transthyretin (TTR).  In January 2014, Alnylam and Sanofi Genzyme formed an alliance to… Submission of a Market Application in the EU
2017-12-18 fremanezumab fremanezumab TEV-48125 (formerly LBR-101/ RN-307) Teva Pharmaceuticals (Israel) migraine monoclonal antibody. TEV -48125 (formerly LBR-101/ RN-307) is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a well-validated target… Acceptation for review of a NDA
2017-12-15 hydrocortisone oral granules Alkindi® (Infacort®) Diurnal Limited (UK) pediatric adrenal insufficiency (0 through 16 years of age) hormone/corticosteroid. Infacort® is a preparation of hydrocortisone specifically designed for use in children suffering from adrenal insufficiency . It is an… Positive opinion for the granting of a Market Authorisation in the EU
2017-12-14 ipilimumab Yervoy® BMS (USA - NY))
  • unresectable (inoperable) or metastatic melanoma
  • pediatric patients 12 years of age and older who have unresectable or metastatic melanoma
  • patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection
monoclonal antibody/immune checkpoint inhibitor. Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is a negative regulator of T-cell activation. Ipilimumab binds to CTLA-4 and blocks… Positive opinion for the granting of a Market Authorisation in the EU
2017-12-14 darvadstrocel - adipose derived allogeneic stem cell therapy Alofisel® (Cx601 - darvadstrocel) Tigenix (Belgium) complex perianal fistulas in patients with Crohn's disease Cell therapy. Cx601 is a suspension of expanded allogeneic adult stem cell (eASCs) product derived from human adipose (fat) tissue (expanded Adipose derived… Positive opinion for the granting of a Market Authorisation in the EU
2017-12-14 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… Positive opinion for the granting of a Market Authorisation in the EU
2017-12-14 tofacitinib Xeljanz® Pfizer (USA - NY) moderate to severe chronic plaque psoriasis kinase inhibitor/Janus kinase inhibitor. Tofacitinib is an oral Janus kinase (JAK) inhibitor. This drug is already approved for the treatment… Granting of a Market Authorisation in the US
2017-12-14 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… Patent infringement lawsuit
2017-12-14 biosimilar version of of trastuzumab - Herceptin® Herzuma® - CT-P6 Teva Pharmaceuticals (Israel) Celltrion (South Korea)
  • HER2-overexpressing breast cancer,
  • HER2-overexpressing  metastatic gastric cancer
biosimilar product/monoclonal antibody. Trastuzumab is a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody approved in many regions for the… Positive opinion for the granting of a Market Authorisation in the EU
2017-12-14 pegunigalsidase alfa (alpha-galactosidase-A) PRX-102 - pegunigalsidase alfa Protalix BioTherapeutics (Israel) Fabry disease enzyme replacement therapy. Pegunigalsidase alfa is a PEGylated, chemically-modified version of the recombinant alpha-galactosidase-A enzyme, in which the protein sub-units… Granting of the orphan status in the EU
2017-12-14 semaglutide Ozempic® Novo Nordisk (Denmark) type 2 diabetes glucagon-like Peptide 1 (GLP-1) analogue. Semaglutide is a human GLP-1 (Glucagon-Like Peptide-1) analogue developed for once-weekly treatment of type 2… Positive opinion for the granting of a Market Authorisation in the EU
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
2017-12-13 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… Granting of a Market Authorisation in the EU
2017-12-13 (infliximab-qbtx) Ixifi ™ - PF-06438179 (biosimilar version of Remicade® (infliximab) Pfizer (USA - NY)
  • rheumatoid arthritis, Crohn's disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis
monoclonal antibody/biosimilar. Infliximab is a tumor necrosis factor alpha (TNF-alpha) inhibitor used to treat a range of autoimmune diseases including rheumatoid… Granting of a Market Authorisation in the US
2017-12-13 cemiplimab REGN2810 Regeneron Pharmaceuticals (USA - NY) Sanofi (France) monoclonal antibody/immune checkpoint inhibitor. REGN2810 is a fully human monoclonal antibody to Programmed Death-1 (PD-1). Cemiplimab is being jointly developed by… Submission of a Market Application in the US