Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2017-11-16 | niraparib | Tesaro (USA - MA) | recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer | Granting of a Market Authorisation in the EU |
2016-10-25 | napabucasin | Boston Biomedical (USA - MA) | pancreatic cancer |
Granting of the orphan status in the EU |
2016-06-20 | napabucasin | Boston Biomedical (USA - MA) | gastric cancer including gastroesophageal junction cancer |
Granting of the orphan status in the US |
2015-08-24 | Argos Therapeutics (USA - NC) | HIV infection |
Granting of a patent | |
2016-11-15 | sacituzumab govitecan - IMMU-132 | Immunomedics (USA - NJ) | Trop-2-positive cancers |
Granting of a patent |
2016-02-05 | sacituzumab govitecan - IMMU-132 | Immunomedics (USA - NJ) | triple-negative breast cancer (TNBC) |
Granting of the Breakthrough Therapy status |
2016-10-19 | labetuzumab govitecan (IMMU-130) | Immunomedics (USA - NJ) | Granting of a patent | |
2016-07-25 | rVSV-EBOV (Ebola) vaccine candidate | Merck&Co (USA - NJ) | Granting of the Breakthrough Therapy status | |
2016-11-18 | Eisai (Japan) | Alzheimer's disease |
Granting of the Breakthrough Therapy status | |
2017-09-14 | anamorelin | Helsinn Group (Switzerland) | anorexia, cachexia, or unintended weight loss in non-small cell lung cancer (NSCLC) patients | Refusal of a Market Autorisation in the EU |
2018-01-26 | [177]Lutetium-DOTA[0]-Tyr[3]-Octreotate/lutetium (177Lu) oxodotreotide | Advanced Accelerator Applications (France) now Novartis (Switzerland) | gastro entero pancreatic neuroendocrine tumors (GEP-NETs) | Granting of a Market Authorisation in the US |
2015-02-12 | chimeric group B adenovirus (11p/3) with deletions in the E3 and E4 regions | PsiOxus Therapeutics (UK) | ovarian cancer |
Granting of the orphan status in the EU |
2016-08-24 | phosphoinositide-3-kinase delta inhibitor | TG Therapeutics (USA - NY) | chronic lymphocytic leukemia |
Granting of the orphan status in the US |
2016-11-21 | 5-(4,6-dimorpholino-1,3,5-triazin-2-yl)-4-(trifluoromethyl)-pyridin-2-amine | PIQUR Therapeutics (Switzerland) | primary central nervous system lymphoma (PCNSL) | Granting of the orphan status in the US |
2017-08-07 | Vernalis (UK) Tris Pharma (USA - NJ) | cough cold | Refusal of a Market Autorisation in the US | |
2017-08-16 | brentuximab vedotin | Takeda Global Research and Development Centre (UK), subsidiary of Takeda Pharmaceutical (Japan) Seattle Genetics (USA - WA) |
|
Submission of an sNDA |
2016-05-02 | Prima Biomed (Australia) | Granting of a patent | ||
2017-02-13 | etanercept biosimilar | Pfizer (USA - NY) | rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis, paediatric plaque psoriasis | Granting of a Market Authorisation in the EU |
2017-01-18 | bezlotoxumab | Merck&Co (USA - NJ) | Clostridium difficile infection recurrence | Granting of a Market Authorisation in the EU |
2017-02-13 | simoctocog alfa (recombinant blood coagulation factor VIII) | Octapharma (Switzerland) | hemophilia A | Granting of a Market Authorisation in the EU |
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