Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2015-03-09 | hydrocinnamate-[Orn-Pro-dCha-Trp-Arg](CH3COO) | Alsonex (Australia) | amyotrophic lateral sclerosis |
Granting of the orphan status in the US |
2015-03-15 | alpha1-proteinase inhibitor | Grifols (Spain) | type 1 diabetes mellitus patients with residual beta-cell function | Granting of the orphan status in the US |
2015-12-17 | amifampridine phosphate | Catalyst Pharmaceuticals (USA -FL) | Lambert Eaton myasthenic syndrome (LEMS) congenital myasthenic syndromes |
Submission of a Market Application in the US |
2017-12-22 | andexanet alfa | Portola Pharmaceuticals (USA - CA) |
|
Acceptation for review of a NDA |
2015-02-25 | ketotifen | Melbourne Laboratories (USA - CA) | mastocytosis |
Granting of the orphan status in the US |
2015-03-03 | dacomitinib | Pfizer (USA - NY) | non-small cell lung cancer with EGFR, HER2, HER4, or DDR2 mutations |
Granting of the orphan status in the US |
2014-09-23 | 4-amino-1-[(1S,4R,5S)-2-fluoro-4,5-dihydroxy-3-(hydroxymethyl) cyclopent-2-en-1-yl] pyrimidin-2-one | Rexahn Pharmaceuticals (USA - MD) | pancreatic cancer |
Granting of the orphan status in the US |
2015-05-21 | 5,7-dichloro-2-methylaminomethyl-8-hydroxyquinolone hydrochloride | Prana Biotechnology (Australia) | Huntington's disease |
Granting of the orphan status in the EU |
2014-07-02 | carbenoxolone | Oxalys Pharmaceuticals (Canada) | Huntington's disease |
Granting of the orphan status in the US |
2017-04-03 | deutetrabenazine | Auspex Pharmaceuticals (USA - CA) now Teva Pharmaceutical Industries (Israel) | chorea associated with Huntington disease | Granting of a Market Authorisation in the US |
2014-11-13 | autologous CD3+ T cells transduced with retroviral vector containing a chimeric antigen receptor directed against CD19 (Autologous CD3+ T cells containing CD19 chimeric antigen receptor) | Juno Therapeutics (USA - WA) | acute lymphoblastic leukemia |
Granting of the orphan status in the US |
2014-04-30 | human plasma derived coagulation protein-Factor XI | Cambryn Biologics (USA - FL) | congenital Factor XI deficiency |
Granting of the orphan status in the US |
2017-07-24 | infliximab | Merck&Co (USA - NJ) Samsung Bioepis (Republic of Korea) | rheumatic arthritis, adult Crohn's disease, pediatric Crohn's disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, psoriasis | Product launch |
2014-09-23 | bivalent ganglioside vaccine consisting of GD2-lactone and GD3-lactone each covalently conjugated to keyhole hemocyanin | MabVax Therapeutics (USA - CA) | neuroblastoma |
Granting of the orphan status in the US |
2014-05-14 | menadione sodium bisulfite | IC-MedTech Corporation (USA - CA) | autosomal dominant polycystic kidney disease |
Granting of the orphan status in the US |
2014-05-14 | menadione sodium bisulfite | IC-MedTech Corporation (USA - CA) | autosomal dominant polycystic liver disease |
Granting of the orphan status in the US |
2014-08-28 | methotrexate | The Universtiy of Kansas Medical Center (USA - KS) | Myasthenia Gravis |
Granting of the orphan status in the US |
2014-10-02 | inhibitor of primary and secondary KIT and PDGFR alpha kinase mutants found in GIST | Deciphera Pharmaceuticals (USA - KS) | gastrointestinal stromal tumors (GIST) |
Granting of the orphan status in the US |
2014-06-12 | mocetinostat | Mirati Therapeutics (USA - CA) | myelodysplastic syndrome |
Granting of the orphan status in the US |
2014-08-07 | mocetinostat | Mirati Therapeutics (USA - CA) | diffuse large B-cell lymphoma |
Granting of the orphan status in the US |
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