Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2013-06-21 | serelaxin | Novartis (Switzerland) | acute heart failure |
Refusal of a Market Authorisation in the EU |
2015-09-03 | filgrastim - biosimilar version of recombinant human granulocyte colony stimulating factor (G-CSF) | Sandoz (Switzerland) | neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients undergoing autologous peripheral blood progenitor cell collection and therapy; patients with severe chronic neutropenia. |
Product launch |
2013-06-28 | eculizumab | Alexion Pharmaceuticals (USA - CT) | neuromyelitis optica | Granting of the orphan status in the EU |
2016-04-05 | infliximab | Hospira (USA - IL) Celltrion (South Korea) |
|
Granting of a Market Authorisation in the US |
2013-06-30 | sipuleucel-T | Dendreon (USA - WA) | asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated |
Reimbursement |
2017-12-27 | mercaptamine | Raptor Pharmaceuticals Europe, now Horizon Pharma (Ireland) | nephropathic cystinosis | Granting of a Market Authorisation in the US |
2013-07-01 | human fibrinogen / human thrombin | Omrix Biopharmaceuticals (USA) | supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis |
Granting of a patent |
2015-04-30 | trenonacog alfa (recombinant human factor IX - IB1001) | Cangene (Canada) now Emergent Biosolutions (USA - MD) | hemophilia B |
Granting of a Market Authorisation in the US |
2013-07-01 | sorafenib | Bayer HealthCare (Germany) Onyx Pharmaceuticals (USA) | locally advanced or metastatic differentiated thyroid cancer refractory to radioactive iodine (RAI) |
Granting of a Market Authorisation in the EU |
2017-12-20 | pertuzumab | Genentech, a member of the Roche Group (USA - Switzerland) Roche (Switzerland) |
|
Granting of a Market Authorisation in the US |
2013-07-10 | coated soft gelatin capsule containing a complex mixture of polyunsaturated free fatty acids derived from fish oils, including multiple long-chain omega-3 and omega-6 fatty acids, with EPA, DHA, and docosapentaenoic acid being the most abundant forms of omega-3 fatty acids | Omthera Pharmaceuticals (USA) AstraZeneca (UK) | severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL) |
|
2014-10-17 | ibrutinib | Johnson&Johson (J&J) (USA - NJ) | previously treated patients with mantle cell lymphoma (MCL) |
Granting of a Market Authorisation in the EU |
2013-07-15 | autologous bone marrow-derived mesenchymal stromal cells secreting neurotrophic factors | Brainstorm Cell Therapeutics (USA- Israel) | amyotrophic lateral sclerosis | |
2013-07-15 | granulocyte-macrophage colony-stimulating factor (GM-CSF) | Serendex ApS (Denmark) | pulmonary alveolar proteinosis | |
2013-07-15 | moxetumomab pasudotox | MedImmune (USA - global biologics arm of AstraZeneca (UK) |
|
Granting of the orphan status in the EU |
2013-07-15 | (1-methyl-2-nitro-1H-imidazole-5-yl)methyl N,N\'-bis(2-bromoethyl) diamidophosphate | Merck KGaA (Germany) | pancreatic cancer | |
2013-07-15 | (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one | Voisin Consulting (France) | follicular lymphoma | |
2014-01-17 | allogeneic motor neuron progenitor cells derived from human embryonic stem cells | California Stem Cell (UK) Ltd - California Stem Cell Inc (USA - CA) | amyotrophic lateral sclerosis |
Granting of the orphan status in the US |
2013-07-15 | belinostat | TopoTarget (Denmark) | malignant thymoma |
Positive opinion for the granting of the orphan status in the EU |
2013-07-15 | dexamethasone sodium phosphate for encapsulation in human autologous erythrocytes | Erydel (Italy) | ataxia telangiectasia |
Granting of the orphan status in the EU |
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