Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2014-07-30 | adeno-associated viral vector serotype 8 containing the human UGT1A1 gene | Fondazione Telethon (Italy) | Crigler-Najjar syndrome |
Granting of the orphan status in the EU |
2014-07-30 | humanised IgG1 monoclonal antibody against human KIR3DL2 | Innate Pharma (France) | cutaneous T-cell lymphoma |
Granting of the orphan status in the EU |
2016-03-23 | lentiviral vector containing the human liver and erythroid pyruvate kinase (PKLR) gene | Centro de Investigación Biomédica en Red (CIBER) (Spain) | pyruvate kinase deficiency |
Granting of the orphan status in the US |
2014-07-30 | macromolecular conjugate of heparin sodium on a polymer backbone | Corline Systems (Sweden) | prevention of ischaemia reperfusion injury associated with solid organ transplantation |
Granting of the orphan status in the EU |
2014-07-30 | obinutuzumab | Roche (Switzerland) | diffuse large B-cell lymphoma | Granting of the orphan status in the EU |
2014-07-30 | recombinant human diamine oxidase | Medical University of Vienna (Austria) | mastocytosis |
Granting of the orphan status in the EU |
2014-10-09 | S3,S13-cyclo(D-tyrolsyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L- aspartyl-L-tryptophyl-N-methyl-L-glycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-N-methyl-L- isoleucinamide) | Amyndas Pharmaceuticals (Greece - USA - PA) | paroxysmal nocturnal hemoglobinuria |
Granting of the orphan status in the US |
2014-07-30 | variant of recombinant human fibroblast growth factor 19 | Diamond BioPharm (UK) | primary biliary cirrhosis |
Granting of the orphan status in the EU |
2014-07-30 | vector based on an adeno-associated virus serotype 2 backbone, pseudo-serotyped with a type 8 capsid, which carries the coding sequence of the human TYMP gene under the control of the human thyroxine binding globulin promote | Vall d\'Hebron Insitute of Research (Spain) | mitochondrial neurogastrointestinal encephalomyopathy |
Granting of the orphan status in the EU |
2014-07-30 | (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N\'-(pyrazin-2-yl)acrylohydrazide | Clinipace GmbH (Germany) Karyopharm Therapeutics (USA - MA) | diffuse large B-cell lymphoma |
Granting of the orphan status in the EU |
2014-07-30 | (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N\'-(pyrazin-2-yl)acrylohydrazide | Clinipace GmbH (Germany) Karyopharm Therapeutics (USA - MA) | acute myeloid leukaemia |
Granting of the orphan status in the EU |
2014-10-20 | [5-amino-1-(4-fluoro-phenyl)-1H-pyrazol-4-yl]-[3-(2,3-dihydroxy-propoxy)-phenyl]-methanone | Synovo (Germany) | pancreatic cancer |
Granting of the orphan status in the US |
2014-10-17 | ibrutinib | Johnson&Johson (J&J) (USA - NJ) | treatment of patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), |
Granting of a Market Authorisation in the EU |
2017-02-08 | alirocumab | Sanofi (France) Regeneron Pharmaceuticals (USA- NY) | adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol |
Patent infringement lawsuit |
2014-07-29 | antibody drug conjugate consisting of fully human anti-guanylyl cyclase C monoclonal antibody linked to the cytotoxic drug monomethyl auristatin E | Millennium Pharmaceuticals (USA - MA) | pancreatic cancer |
Granting of the orphan status in the US |
2015-03-03 | pneumococcal conjugate vaccine | Pfizer (USA - NY) | prevention of pneumococcal pneumonia |
Granting of a Market Authorisation in the EU |
2014-08-08 | human albumin | Baxter (USA - IL) | hypovolemia, hypoalbuminemia due to general causes, burns and in patients undergoing cardiopulmonary bypass surgery |
Granting of a Market Authorisation in the US |
2014-08-09 | software | Accenture (Ireland) Philips (The Netherlands) | amyotrophic lateral sclerosis |
Product launch |
2014-08-09 | olodaterol | Boehringer Ingelheim (Germany) | chronic obstructive pulmonary disease (COPD) |
Granting of a Market Authorisation in the US |
2015-03-11 | ruxolitinib | Incyte (USA - DE) Novartis (Switzerland) | treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea
|
Granting of a Market Authorisation in the EU |
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