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Number of results: 2851
Date Compound Product name Company Disease Action mechanism Type of Information
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
2017-11-23 recombinant human nerve growth factor Oxervate® (cenegermin eye drops - recombinant human nerve growth factor) Dompé (Italy) neurotrophic keratitis protein. Cenegermin is the recombinant version of the human nerve growth factor (NGF) discovered by Nobel Laureate Rita Levi Montalcini. Patients… Product launch
2017-11-16 niraparib Zejula® Tesaro (USA - MA) recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer poly ADP ribose polymerase PARP inhibitor/PARP inhibitor. Niraparib is an orally administered poly polymerase (PARP) inhibitor, currently in late-stage development for… Granting of a Market Authorisation 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 human fibrinogen / human thrombin VeraSeal® Grifols (Spain) use as a sealant during surgical operations in adults protein. When the two active substances are mixed together, thrombin cuts fibrinogen up into smaller units called fibrin. The fibrin… Granting of a Market Authorisation in the EU
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 padeliporfin di-potassium Tookad® Steba Biotech (Luxembourg) previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy  of at least 10 years photosensitizer/photodynamic therapy. Tookad® is a first-in-class photosensitizer derived from palladium-substituted bacteriochlorophyll and developed in collaboration with the Weizmann Institute. It… Granting of a Market Authorisation in the EU
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
2017-11-10 buprenorphine and naloxone sublingual tablet Zubsolv® Mundipharma (UK) Orexo (Sweden) opioid dependence opioid agonist/opioid receptor antagonist. Buprenorphine and naloxone are used in addictive disorders and act as opioid agonist and opioid receptor antagonist,… Granting of a Market Authorisation in the EU