Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2015-03-23 | mifepristone | FGK Representative Service (Germany) | Cushing’s syndrome |
Withdrawal of a market application in the EU |
2016-01-23 | ipilimumab and nivolumab | BMS (USA - NY) | BRAF V600 wild-type, unresectable or metastatic melanoma BRAF V600 mutation-positive unresectable or metastatic melanoma |
Granting of a Market Authorisation in the US |
2016-05-26 | autologous CD34+ cells transduced to express adenosine deaminase (ADA) | Orchard Therapeutics (UK) | adenosine deaminase severe combined immunodeficiency syndrome (ADA-SCID) | Granting of a Market Authorisation in the EU |
2016-08-16 | reslizumab | Teva Pharmaceuticals (Israel) | inadequately controlled asthma in adult and adolescent patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based regimen |
Granting of a Market Authorisation in the EU |
2015-06-15 | octreotide capsules | Chiasma (USA - MA - Israel) | acromegaly |
Submission of an NDA |
2015-06-18 | Aimmune Therapeutics (USA - CA) | peanut-allergic children and adolescents 4-17 years of age |
Granting of a Fast Track status | |
2015-08-10 | anti-H5N1 equine immunoglobulin F(ab\')2 fragments | Fab’entech (France) | avian influenza |
Granting of the orphan status in the EU |
2015-07-28 | doxorubicin | Double Bond Pharmaceutical (Sweden) | hepatoblastoma |
Granting of the orphan status in the EU |
2015-07-28 | human plasminogen | ProMetic BioTherapeutics (Canada) | plasminogen deficiency |
Granting of the orphan status in the EU |
2015-08-10 | lanreotide acetate | Prof. Dr R.T.Gansevoort (The Netherlands) | autosomal dominant polycystic kidney disease |
Granting of the orphan status in the EU |
2015-07-28 | synthetic hypericin | Kinesys Consulting (UK) Soligenix (USA - NJ) | cutaneous T-cell lymphoma (CTCL) | Granting of the orphan status in the EU |
2015-07-28 | 2-((3-((4-((3-aminopropyl)amino)butyl)amino)propyl)amino)-N-((5S,5aS,8aR,9R)-9-(4-hydroxy-3,5-dimethoxyphenyl)-8-oxo 5,5a,6,8,8a,9-hexahydrofuro[3\',4\':6,7]naphtho[2,3-d][1,3]dioxol-5-yl)acetamide, tetrahydrochloride | Pierre Fabre Médicament (France) | acute myeloid leukaemia |
Granting of the orphan status in the EU |
2015-07-28 | adenovirus-associated viral vector serotype 2 containing the human RPE65 gene | Alan Boyd Consultants (UK) | retinitis pigmentosa |
Granting of the orphan status in the EU |
2015-07-28 | allogeneic human adult stem cells, isolated from skeletal muscle and expanded ex vivo | Karl Rouger (France) | Duchenne muscular dystrophy |
Granting of the orphan status in the EU |
2015-07-28 | artesunate | Dr Ulrich Granzer (Germany) | malaria |
Granting of the orphan status in the EU |
2015-07-28 | beloranib | Dr Ulrich Granzer (Germany) Zafgen (USA - MA) | craniopharyngioma |
Granting of the orphan status in the EU |
2015-07-28 | cannabidiol (2-[(1R,6R)-3-Methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) | GW Pharmaceuticals (UK) | perinatal asphyxia |
Granting of the orphan status in the EU |
2015-07-28 | glycyl-L-2-methylprolyl-L-glutamic acid | QRC Consultants (UK) | fragile X syndrome |
Granting of the orphan status in the EU |
2015-07-28 | hydrocinnamate-[Orn-Pro-dCha-Trp-Arg]acetate | PBS Regulatory Consulting Group (USA - MA)/Alsonex (Australia) | amyotrophic lateral sclerosis |
Granting of the orphan status in the EU |
2015-07-28 | inecalcitol | Hybrigenics (France) | acute myeloid leukaemia |
Granting of the orphan status in the US |
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