Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2017-08-21 | buprenorphine and samidorphan | Alkermes (Ireland) | major depressive disorder (MDD) | Submission of a Market Application in the US |
2015-01-29 | darunavir - cobicistat | Janssen-Cilag International, a J&J company (USA - NJ) | HIV1-infection |
Granting of a Market Authorisation in the US |
2013-10-23 | Autologous ex-vivo-expanded leucocytes treated with 5-aza-2’-deoxycytidine | CytoVac (Denmark) | glioma | |
2013-10-08 | defibrotide | Jazz Pharmaceuticals (Ireland) | graft-versus-host disease |
Granting of a patent |
2013-11-13 | recombinant human insulin receptor monoclonal antibody-fused iduronate 2-sulfatase | Voisin Consulting (France) | mucopolysaccharidosis type II (Hunter's syndrome) |
Granting of the orphan status in the EU |
2013-10-23 | sorafenib tosylate | Bayer HealthCare (Germany) Onyx Pharmaceuticals (USA) | follicular thyroid cancer, papillary thyroid cancer, medullary thyroid cancer, anaplastic thyroid cancer, recurrent or metastatic follicular or papillary thyroid cancer |
Granting of a Market Authorisation in the US |
2013-10-23 | human monoclonal antibody against human interleukin 13 | Novartis (Switzerland) | eosinophilic oesophagitis |
|
2013-11-13 | ibrutinib | Janssen-Cilag International - J&J (USA - NJ) | diffuse large B-cell lymphoma |
Granting of the orphan status in the EU |
2013-10-23 | sirolimus | S-Cubed Limited (Denmark) | prevention of arteriovenous access dysfunction in patients undergoing surgical creation of an arteriovenous access for haemodialysis |
Granting of a patent |
2013-10-23 | soraprazan | Katairo (Germany) | Stargardt’s disease | |
2013-10-23 | synthetic 12 amino acids peptide designed after subcommissural organ spondin | Neuronax (France) | spinal cord injury | |
2013-10-23 | tivantinib | Daiichi Sankyo (Japan) | hepatocellular carcinoma | |
2013-10-23 | trebananib | Amgen (USA) | ovarian cancer |
Granting of a patent |
2014-09-03 | dolutegravir with abacavir and lamivudine | Viiv Healthcare (UK - USA) | HIV infection | Granting of a Market Authorisation in the EU |
2018-08-10 | patisiran (ALN-TTR02) | Alnylam Pharmaceuticals (USA - MA) Sanofi (France) |
|
Granting of a Market Authorisation in the US |
2013-11-20 | balugrastim - recombinant G-CSF fused to human albumin | Teva Pharmaceuticals (Israel) | prophylaxis against chemotherapy-induced neutropenia |
Withdrawal of a market application in the EU |
2013-11-20 | allogeneic and autologous haptenised and irradiated cells and cell lysates derived from glioma | ERC Belgium | glioma | |
2014-09-19 | idelalisib | Janssen-Cilag International - J&J (USA - NJ) | follicular lymphoma |
Granting of a Market Authorisation in the EU |
2013-11-20 | Lactobacillus acidophilus and Bifidobacterium bifidum | Laboratorio Farmaceutico (Italy) | prevention of necrotising enterocolitis |
|
2017-04-26 | recombinant human parathyroid hormone | NPS Pharma UK (UK) NPS Pharmaceuticals (USA - NJ) now Shire (UK - USA) |
|
Granting of a Market Authorisation in the EU |
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