Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2017-04-20 | rituximab | Hôpital Foch (France) | solid organ transplantation | Granting of the orphan status in the EU |
2016-03-07 | AstraZeneca (UK) | type A strain influenza | Granting of a Fast Track status | |
2016-05-10 | selumetinib | AstraZeneca (UK) | adjuvant treatment of patients with stage III or stage IV differentiated thyroid cancer | Granting of the orphan status in the US |
2017-04-20 | human normal immunoglobulin for treatment in solid organ transplantation | Hopital Foch (France) | solid organ transplantation | Granting of the orphan status in the EU |
2017-04-20 | autologous adult bone marrow-derived non-expanded CD133+ haematopoietic stem cells | Igenomix (Spain) | Asherman's syndrome | Granting of the orphan status in the EU |
2017-04-20 | estetrol | Mithra Pharmaceuticals (Belgium) | neonatal encephalopathy | Granting of the orphan status in the EU |
2017-04-20 | emeramide | NBMI Science (Sweden) | mercury toxicity | Granting of the orphan status in the EU |
2017-04-20 | modified messenger ribonucleic acid encoding human ornithine transcarbamylase enzyme encapsulated into lipid nanoparticles | PhaseRx (USA - WA) | ornithine transcarbamylase deficiency | Granting of the orphan status in the EU |
2017-05-22 | ursodeoxycholic acid | IntraBio (UK) | Niemann-Pick disease | Granting of the orphan status in the EU |
2017-05-22 | chimeric locked nucleic acid deoxynucleoside phosphorothioate-linked oligonucleotide inhibitor directed against microRNA-155-5p | Miragen Therapeutics (USA - CO) | cutaneous T-cell lymphoma | Granting of the orphan status in the EU |
2017-03-30 | oligonucleotide inhibitor of microRNA miR-155-5p | Miragen Therapeutics (USA - CO) | mycosis fungoides | Granting of the orphan status in the US |
2017-05-22 | poly(oxy-1,2-ethanediyl),.alpha.-hydro-.omega.-hydroxy-,15,15'-diester with N-acetyl-L-isoleucylL-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-.alpha.-aspartyl-L-tryptophylglycyl-Lalanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxyL-lysinamide cyclic (2.fwdarw.12)-(disulfide); where two identical synthetic peptide domains are covalently linked at the ends of the polyethylene glycol chain | Best Regulatory Consulting (UK) | paroxysmal nocturnal hemoglobinuria | Granting of the orphan status in the EU |
2017-05-22 | recombinant adeno-associated viral vector serotype 6 encoding the B-domain-deleted human factor VIII | Coté Orphan Consulting UK (UK) | hemophilia A | Granting of the orphan status in the EU |
2017-05-22 | recombinant human interleukin-7 fused to a hybrid crystallisable fragment region of a human antibody | NeoImmuneTech, INC., Spólka Akcyjna, Oddzial w Polsce | idiopathic CD4 lymphocytopenia | Granting of the orphan status in the EU |
2017-05-22 | sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl) carboxamide | TMC Pharma Services (UK) | acute myeloid leukaemia | Granting of the orphan status in the EU |
2017-05-22 | tamoxifen citrate | GB Pharma (Italy) | cystic fibrosis | Granting of the orphan status in the EU |
2017-06-02 | nivolumab | BMS (USA - NY) | locally advanced unresectable or metastatic urothelial carcinoma (mUC) | Granting of a Market Authorisation in the EU |
2017-07-10 | chondrocytes | co.don AG (Germany) |
|
Granting of a Market Authorisation in the EU |
2017-05-18 | beclometasone / formoterol / glycopyrronium bromide | Chiesi Farmaceutici (Italy) | maintenance treatment of moderate to severe chronic obstructive pulmonary disease (COPD) | Positive opinion for the granting of a Market Authorisation in the EU |
2017-07-13 | biosimilar rituximab - biosimilar version of Mabthera®/Rituxan® | Celltrion (South Korea) |
|
Granting of a Market Authorisation in the EU |
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