Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2014-05-20 | beloranib | Dr Ulrich Granzer (Germany) | Prader-Willi syndrome |
Granting of the orphan status in the EU |
2014-07-04 | humanised Fc engineered monoclonal antibody against CDl9 | Morphosys (Germany) | chronic lymphocytic leukaemia /small lymphocytic lymphoma |
Granting of the orphan status in the EU |
2014-05-20 | norursodeoxycholic acid | Dr Falk Pharma (Germany) | primary sclerosing cholangitis |
Granting of the orphan status in the EU |
2016-11-09 | palbociclib | Pfizer (USA - NY) |
|
Granting of a Market Authorisation in the EU |
2015-08-03 | rociletinib | Clovis Oncology (USA - CO) | treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation |
Submission of a Market Application in the US |
2015-09-01 | purified autologous type 1 regulatory T lymphocytes specific for human type II collagen | TxCell (France) | non-infectious uveitis |
Granting of the orphan status in the US |
2014-05-24 | simoctocog alfa (recombinant blood coagulation factor VIII) | Octapharma (Switzerland) | treatment and prophylaxis of bleeding in paediatric and adult patients with haemophilia A (congenital factor VIII deficiency) |
Granting of a Market Authorisation in the EU |
2014-05-24 | voriconazole | Pfizer (USA - NY) | prophylaxis of invasive fungal infections (IFI) in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients |
Positive opinion for the granting of a Market Authorisation in the EU |
2015-10-09 | dalbavancin | Durata Therapeutics (USA - IL), an Actavis' subsidiary (USA - NJ), now Allergan (Ireland) | acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes acute bacterial skin and skin structure infections (ABSSSI) in adults caused by designated susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) |
Submission of an sNDA |
2014-05-14 | inecalcitol | Hybrigenics (France) | chronic lymphocytic leukaemia / small lymphocytic lymphoma |
Granting of the orphan status in the US |
2014-05-14 | targeted gastrin 17 complexed peptide | Tyg Oncology (UK) | pancreatic cancer |
Granting of the orphan status in the US |
2014-05-27 | 4-{[(2R,3S,4R,5S)-4-(4-Chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid | Roche (Switzerland) | acute myeloid leukemia |
Granting of the orphan status in the EU |
2014-05-27 | recombinant humanized monoclonal antibody of the immunoglobulin G1 subclass directed against colony stimulating factor-1 receptor expressed on macrophages | Genentech, a member of the Roche Group (USA - Switzerland) | pigmented villonodular synovitis and tenosynovial giant cell tumor |
Granting of the orphan status in the US |
2014-05-21 | all-cis-docosa-4,7,10,13,16,19-hexaenoic acid | Natac Pharma (Spain) | retinitis pigmentosa |
Granting of the orphan status in the US |
2014-05-28 | 5-[1-(2,6-dichlorobenzyl)piperidin-4-ylmethoxy]quinazoline-2,4-diamine dihydrochloride | Repligen (Sweden) | 5q spinal muscular atrophy |
Granting of a patent |
2014-06-11 | everolimus | Novartis (Switzerland) | diffuse large B-cell lymphoma | Granting of the orphan status in the USA |
2014-06-11 | metformin | EffRx Pharmaceuticals (Switzerland) | pediatric polycystic ovary syndrome |
Granting of the orphan status in the USA |
2014-06-11 | afatinib | Boehringer Ingelheim (Germany) | malignant brain and central nervous system tumors |
Granting of the orphan status in the US |
2014-07-29 | human monoclonal antibody against Epidermal Growth Factor Receptor (ABT-806) conjugated to monomethylauristatin F | Abbvie (USA - IL) | glioblastoma multiforme |
Granting of the orphan status in the EU |
2014-06-11 | 3\'\'-Tert-butyl-4\'-(2-hydroxyethoxy)-4\'\'-(pyrrolidin-1-yl)(1,1\':3\',1\'\')terphenyl-4-carboxylic acid | Galderma (Switzerland) | congenital ichthyosis |
Granting of the orphan status in the USA |
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