Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2016-10-07 | daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone | Janssen Biotech, a J&J company (USA - NJ) | relapsed and refractory multiple myeloma | Granting of a Fast Track status |
2016-05-17 | ofatumumab in combination with fludarabine and cyclophosphamide | Novartis (Switzerland) | relapsed chronic lymphocytic leukemia (CLL) |
Granting of a Fast Track status |
2016-04-26 | recombinant human alkaline phosphatase | AM-Pharma (The Netherlands) | acute kidney injury |
Granting of a Fast Track status |
2016-03-22 | ibudilast | MediciNova (USA - CA) | multiple sclerosis |
Granting of a Fast Track status |
2016-01-04 | doxorubicin | Oasmia Pharmaceutical (Sweden) | Submission of an NDA | |
2017-02-23 | sodium zirconium cyclosilicate | AstraZeneca (UK) | hyperkalemia | Positive opinion for the granting of a Market Authorisation in the EU |
2016-05-02 | human normal immunoglobulin (10%), recombinant human hyaluronidase | Baxalta (USA - IL) | replacement therapy for pediatric patients with primary and certain secondary immunodeficiencies |
Positive opinion for the granting of a Market Authorisation in the EU |
2017-06-15 | biosimilar rituximab - biosimilar version of Mabthera®/Rituxan® | Sandoz (Switzerland) | non-Hodgkin's lymphoma (follicular lymphoma and diffuse large B-cell lymphoma), chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis | Granting of a Market Authorisation in the EU |
2016-03-08 | antigen-specific Type 1 Treg cell therapy | TxCell (France) | inflammatory bowel disease |
Granting of a patent |
2017-06-01 | cerliponase alfa | BioMarin Pharmaceutical (USA - CA) | late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), a form of Batten disease | Granting of a Market Authorisation in the EU |
2016-02-08 | B,1-[(4R,5R)-4-hydroxy-N2-[[4’’-(pentyloxy)[1,1’:4’,1’’-terphenyl]-4-yl]carbonyl]-5-[2-(trimethylammonio)ethoxy]-L-ornithine]-4-[(4S)-4-hydroxy-4-(4-hydroxyphenyl)-L-allothreonine] | Cidara Therapeutics (USA - CA) | candidemia and invasive candidiasis infections caused by susceptible Candida spp |
Granting of the orphan status in the US |
2016-03-28 | anti-CD45 murine monoclonal antibody radiolabeled with 131I | Actinium Pharmaceuticals (USA - NJ) | acute myeloid leukemia |
Granting of the orphan status in the US |
2016-02-02 | drug product services | Lonza (Switzerland) | Product launch | |
2016-01-20 | venetoclax in combination with (rituximab) | Roche (Switzerland) | relapsed or refractory chronic lymphocytic leukaemia (CLL) | Granting of the Breakthrough Therapy status |
2016-11-03 | rituximab | Roche (Switzerland) | previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL) |
Submission of a Market Application in the US |
2016-01-14 | asunercept | Apogenix (Germany) | glioblastoma | Granting of a patent |
2016-06-13 | etrasimod | Arena Pharmaceuticals (USA - CA) | ulcerative colitis | Granting of a patent |
2016-10-14 | 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]- phenyl}-2-oxo-acetamide | F2G (UK) | invasive aspergillosis |
Granting of the orphan status in the EU |
2017-04-25 | tazemetostat | Epizyme (USA - MA) |
|
Granting of a Fast Track status |
2017-11-13 | human monoclonal antibody targeting human sclerostin | Mereo BioPharma (UK) | osteogenesis imperfecta | Granting of a Fast Track status |
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