Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2015-11-11 | humanised monoclonal antibody of the IgG4 kappa isotype targeting CD47 | The Chancellor, Masters and Scholars of the University of Oxford (UK) - Stanford University (USA - CA) | acute myeloid leukaemia |
Granting of the orphan status in the EU |
2015-11-11 | sodium phenylbutyrate | Fondazione Telethon (Italy) | pyruvate dehydrogenase complex deficiency |
Granting of the orphan status in the EU |
2016-04-28 | autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor | Kite Pharma (USA - CA) | mantle cell lymphoma | Granting of the orphan status in the US |
2015-10-09 | nimodipine | Dr Stefan Blesse (Germany) | aneurysmal subarachnoid haemorrhage |
Granting of the orphan status in the EU |
2015-10-09 | ovine-specific immunoglobulin (Fab) fragments raised against Vipera berus venom | MicroPharm (UK) | snakebite envenomation |
Granting of the orphan status in the EU |
2015-10-09 | synthetic hepcidin | Emas Pharma (UK) | beta thalassemia intermedia and major |
Granting of the orphan status in the EU |
2016-02-04 | synthetic peptide L-cysteine, L-cysteinylglycyl-L-glutaminyl-L-arginyl-L-.alpha.-glutamyl-Lthreonyl-L-prolyl-L-.alpha.-glutamylglycyl-L-alanyl-L-.alpha.-glutamyl-L-alanyl-L-lysyl-L-prolyl-Ltryptophyl-L-tyrosyl-,cyclic (1.fwdarw.17)-disulfide | Apeptico Forschung und Entwicklung GmbH (Austria) | primary graft dysfunction following lung transplantation |
Granting of the orphan status in the US |
2015-10-14 | 2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione | GenKyoTex (Switzerland) | systemic sclerosis |
Granting of the orphan status in the US |
2015-10-09 | dronabinol and cannabidiol | GW Research (UK) | glioma |
Granting of the orphan status in the EU |
2015-10-09 | mazindol | NeuroLifeSciences (France) | narcolepsy |
Granting of the orphan status in the EU |
2015-10-09 | N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenamido)ethyl)-2-hydroxybenzamide | FGK Representative Service (Germany) | Duchenne muscular dystrophy |
Granting of the orphan status in the EU |
2015-11-16 | recombinant adeno-associated viral vector expressing the human CNGA3 gene | TMC Pharma Services (UK) /Applied Genetic Technologies (USA - FL) | achromatopsia caused by mutations in the CNGA3 gene |
Granting of the orphan status in the US |
2015-10-09 | sirolimus | Desitin Arzneimittel (Germany) | tuberous sclerosis | Granting of the orphan status in the EU |
2015-10-09 | three chimeric human/murine monoclonal antibodies against the Ebola (Zaire) surface glycoprotein | Dr Stefan Blesse (Germany) | Ebola fever |
Granting of the orphan status in the EU |
2015-10-09 | autologous human peripheral blood Vdelta1+ T lymphocytes activated in vitro by cytokine and monoclonal antibody treatment | Lymphact - Lymphocyte Activation Technologies (Portugal) | chronic lymphocytic leukaemia small lymphocytic lymphoma |
Granting of the orphan status in the US |
2018-09-27 | abemaciclib | Eli Lilly (USA -IN) |
|
Granting of a Market Authorisation in the EU |
2016-07-15 | fixed-dose combination of saxagliptin and dapagliflozin | AstraZeneca (UK) | type 2 diabetes |
Granting of a Market Authorisation in the EU |
2015-09-29 | glyburide | Remedy Pharmaceuticals (USA - NY) | acute spinal cord injury |
Granting of the orphan status in the US |
2015-10-26 | Vermillion (USA - TX) | risk of malignancy for ovarian cancer |
Granting of a Market Authorisation in the EU | |
2016-04-18 | Mycobacterium phlei Cell wall-Nucleic Acid complex | Telesta Therapeutics (Canada) | non-muscle invasive bladder cancer at high risk of recurrence or progression in adult patients who failed prior Bacillus Calmette-Guérin (BCG) immunotherapy, e.g., in patients who are BCG-refractory or BCG-relapsing |
Refusal of a Market Authorisation in the US |
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