Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2016-03-21 | exenatide | Alan Boyd Consultants (UK) | idiopathic intracranial hypertension |
Granting of the orphan status in the EU |
2016-03-21 | N-acetyl-D-mannosamine monohydrate | Escala Therapeutics (USA - NY) | GNE myopathy also known as hereditary inclusion body myopathy (HIBM) |
Granting of the orphan status in the EU |
2016-04-28 | brincidofovir | Chimerix (USA - NC) | prevention of cytomegalovirus disease |
Granting of the orphan status in the EU |
2016-04-28 | human/murine chimeric monoclonal antibody against endoglin | Tracon Pharmaceuticals (USA - CA) | soft tissue sarcoma |
Granting of the orphan status in the EU |
2016-04-28 | human Wilms tumor protein 1 peptides (Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-ProSer-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met-His-Gln-Arg-Asn-Met-Thr-LysLeu and Pro-Gly-Cys-Asn-Lys-Arg-Tyr-Phe-Lys-Leu-Ser-His-Leu-Gln-Met-His-Ser-Arg-Lys-His-ThrGly) | Sellas Life Sciences Group (Switzerland) | malignant mesothelioma |
Granting of the orphan status in the EU |
2016-04-28 | (1E,6E)-1,7-bis(3,4-dimethoxyphenyl)-4-cyclobutylmethyl-1,6-heptadiene-3,5-dione | Coté Orphan Consulting (UK) | X-linked spinal and bulbar muscular atrophy (Kennedy’s disease) |
Granting of the orphan status in the EU |
2016-04-28 | 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5- triazin-2-yl)amino]propan-2-ol methanesulfonate | Celgene (USA - NJ) | acute myeloid leukaemia |
Granting of the orphan status in the EU |
2016-04-28 | antisense oligonucleotide complementary to the exonic splicer enhancer sequence atintron 26 of the centrosomal protein 290 pre-mRNA | ProQR Therapeutics (The Netherlands) | Leber’s congenital amaurosis | Granting of the orphan status in the US |
2016-04-28 | autologous dermal fibroblasts genetically modified ex vivo with a lentiviral vector containing the human COL7A1 gene | Intrexon Actobiotics (The Netherlands) | epidermolysis bullosa |
Granting of the orphan status in the EU |
2016-04-28 | autologous stromal vascular cell fraction from adipose tissue | Cytori Therapeutics (USA - CA) | systemic sclerosis |
Granting of the orphan status in the EU |
2016-04-28 | combination of 4-hydroxyandrostenedione, Serenoa serrulata fruit extract and alpha lipoic acid | Dr Regenold GmbH Development·Regulatory·Market Access (Germany) | multiple symmetric lipomatosis |
Granting of the orphan status in the EU |
2016-04-28 | fluocinolone acetonide | Campharm Ltd (UK) | non-infectious uveitis |
Granting of the orphan status in the EU |
2016-04-28 | N-carboxymethyl-glycyl-L-threonyl-L-histidyl-L-3,3-diphenylalanyl-L-piperidincarboxy-3-yl-Larginyl-L-S-methylthio-cystyl-L-arginyl-L-tryptophyl-aminohexanyl-N-carboxamidomethyl-glycine N-hexadecylamide | QRC Consultants (UK) | beta thalassaemia intermedia and major |
Granting of the orphan status in the EU |
2016-04-28 | recombinant human cerebral dopamine neurotrophic factor | Herantis Pharma (Finland) | amyotrophic lateral sclerosis |
Granting of the orphan status in the EU |
2016-04-28 | resiquimod | Galderma (Switzerland) | cutaneous T-cell lymphoma |
Granting of the orphan status in the EU |
2016-04-28 | S-acetyl-(S)-4'-phosphopantetheine, calcium salt | Acies Bio (Slovenia) | pantothenate kinase-associated neurodegeneration (PKAN) |
Granting of the orphan status in the EU |
2016-02-02 | influenza vaccine | GSK (UK) | active immunisation against influenza A subtype viruses and type B viruses, in children six months through 35 months of age |
Submission of an extension indication |
2018-09-20 | pegfilgrastim - biosimilar version of Neulasta® | Sandoz (Switzerland) | reduction of the duration of neutropenia and the occurrence of febrile neutropenia in cancer patients | Positive opinion for the granting of a Market Authorisation in the EU |
2018-07-26 | biosimilar epoetin alfa | Sandoz (Switzerland) |
|
Positive opinion for the granting of a Market Authorisation in the EU |
2018-05-22 | ixekizumab | Eli Lilly (USA -IN) | moderate-to-severe plaque psoriasis | Granting of a Market Authorisation in the EU |
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