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Number of results: 2842
Date Compound Product name Company Disease Action mechanism Type of Information
2017-12-12 tofacitinib Xeljanz® Pfizer (USA - NY) kinase inhibitor/Janus kinase inhibitor. Tofacitinib is an oral selective Janus kinase (JAK) inhibitor. Tofacitinib preferentially inhibits JAK1 and JAK3 leading to… Submission of a Market Application in the US
2017-12-12 NextCollect™ Urine Collection and DNA Preservation Kit Trovagene (USA - CA) NextCollect™ is a proprietary high volume urine specimen collection and stabilization kit. Formulated DNA preservative solution is integrated into the… Product launch
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
2017-12-08 latanoprostene bunod ophthalmic solution Vyzulta™/Vesneo® (latanoprostene bunod - previously known as BOL-303259-X and NCX 116) ) Valeant Pharmaceuticals (Canada)
  • reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension
prostaglandin analog. Latanoprostene bunod is a nitric oxide-donating prostaglandin F2-alpha analog.  Upon instillation in the eye, latanoprostene bunod is rapidly metabolized… Product launch
2017-12-07 adenovirus associated viral vector serotype 5 containing the human RPE65 gene AAV2/5-OPTIRPE65 (A001) - adenovirus associated viral vector serotype 5 containing the human RPE65 gene MeiraGTx (USA - NY) Leber congenital amaurosis gene therapy. A001 is an adeno-associated virus (AAV2/5) investigational gene therapy designed to deliver a codon-optimized RPE65 cDNA under the control… Granting of the orphan status in the US
2017-12-07 adeno-associated virus serotype 2/6 (rAAV2/6) vectors encoding zinc finger nucleases (ZFNs) and the human alpha-L-iduronidase (hIDUA) gene SB-318 Sangamo Therapeutics (USA - CA) previously known as Sangamo Biosciences mucopolysaccharidosis type I (MPS I) gene therapy. Using Sangamo's zinc finger nuclease (ZFN) genome editing technology, SB-318 is designed as a single treatment strategy intended to… Positive opinion for the granting of the orphan status in the EU
2017-12-07 adeno-associated virus serotype 2/6 (rAAV2/6) vectors encoding zinc finger nucleases (ZFNs) and the human iduronate 2-sulfatase (hIDS) gene SB-913 Sangamo Therapeutics (USA - CA) previously known as Sangamo Biosciences mucopolysaccharidosis type II (MPS II) gene therapy Positive opinion for the granting of the orphan status in the EU
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 human IgG2 anti-monoclonal antibody directed against mucosal addressin cell adhesion molecule (MAdCAM) SHP647 (PF-00547659) Shire (UK - USA)
  • treatment of pediatric patients with moderately to severely active ulcerative colitis (UC)
monoclonal antibody. SHP647/PF-00547659 is a fully-human monoclonal antibody that is designed to directly target a gastrointestinal endothelial adhesion molecule known as… Granting of the orphan status in the US
2017-11-16 sunitinib Sutent® Pfizer (USA - NY) treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy kinase inhibitor/multi-kinase inhibitor. Sutent® (sunitinib malate) is an oral multi-kinase inhibitor that was approved in the United States in 2006 for… 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 human monoclonal antibody targeting human sclerostin BPS-804 - human monoclonal antibody targeting human sclerostin Mereo BioPharma (UK) osteogenesis imperfecta monoclonal antibody. BPS-804 is a fully human monoclonal antibody that works by inhibiting sclerostin, which inhibits the activity of osteoblasts. Mereo… Granting of a Fast Track status
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
2017-11-10 biosimilar version of Humira®(adalimumab) - adalimumab-adbm Cyltezo® - BI 695501 Boehringer Ingelheim (Germany)
  • ankylosing spondylitis, Crohn’s disease, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, hidradenitis suppurativa, uveitis.
monoclonal antibody/biosimilar product/TNF alpha inhibitor. Cyltezo® (adalimumab-adbm) is a biosimilar version of the monoclonal antibody adalimumab (Humira®). Adalimumab specifically binds to… Granting of a Market Authorisation in the EU
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