Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2016-03-10 | autologous CD4+/CD8+ T cells expressing a CD19 chimeric antigen receptor and truncated epidermal growth factor receptor | Juno Therapeutics (USA - WA) | diffuse large B-cell lymphoma. | Granting of the orphan status in the US |
2018-09-20 | brigatinib | Ariad Pharmaceuticals (USA - MA) now Takeda Pharmaceutical (Japan) | patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib | Positive opinion for the granting of a Market Authorisation in the EU |
2016-04-19 | 2-[(1R,6R)-3-Methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol | GW Pharmaceuticals (UK) | tuberous sclerosis complex |
Granting of the orphan status in the US |
2016-06-13 | budesonide oral suspension | Shire (UK - USA) | eosinophilic esophagitis | Granting of the Breakthrough Therapy status |
2018-08-31 | neratinib | Puma Biotechnology (USA - CA) |
|
Granting of a Market Authorisation in the EU |
2016-08-22 | AstraZeneca (UK) Eli Lilly (USA - IN) | Alzheimer´s disease |
Granting of a Fast Track status | |
2016-08-16 | humanized IgG4 monoclonal antibody that binds to the SEMA4D antigen | Vaccinex (USA - NY) | Huntington's disease |
Granting of the orphan status in the US |
2016-08-10 | dusquetide | Soligenix (USA - NJ) | macrophage activation syndrome | Granting of the orphan status in the US |
2016-08-25 | LAG-3 monoclonal antibody | Prima Biomed (Australia) | prevention of organ transplant rejection, autoimmune diseases |
Granting of a patent |
2016-08-25 | ublituximab | TG Therapeutics (USA - NY) | neuromyelitis optica neuromyelitis optica spectrum disorder |
Granting of the orphan status in the US |
2016-10-18 | combination comprising rifabutin, clarithromycin, and clofazamine | Redhill Biopharma (Israel) | multiple sclerosis |
Granting of a patent |
2016-08-23 | recombinant human interleukin-3 truncated diphtheria toxin fusion protein | Stemline Therapeutics (USA - NY) | blastic plasmacytoid dendritic cell neoplasm |
Granting of the Breakthrough Therapy status |
2017-08-24 | ribociclib in combination with letrozole | Novartis (Switzerland) |
|
Granting of a Market Authorisation in the EU |
2018-09-21 | pegfilgrastim - biosimilar version of Neulasta® | Coherus BioSciences (USA - CA) - ERA Consulting (Germany) |
|
Granting of a Market Authorisation in the EU |
2017-08-24 | adalimumab | Samsung Bioepis (Republic of Korea) Biogen (USA - CA) | rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, uveitis. | Granting of a Market Authorisation in the EU |
2018-06-01 | pegfilgrastim - biosimilar version of Neulasta® | Apotex (Canada) | reduction in the duration of neutropenia | Granting of a Market Authorisation in Canada |
2016-11-16 | pegfilgrastim - biosimilar version of Neulasta® | Gedeon Richter (Hungary) | neutropenia | Withdrawal of a market application in the EU |
2017-01-04 | teriparatide (biosimilar version of Forsteo®) | Gedeon Richter (Hungary) Stada (Germany) | osteoporosis | Granting of a Market Authorisation in the EU |
2016-07-15 | biosimilar version of insulin glargin | Biocon (India) Fujifilm Pharma (Japan) | Product launch | |
2015-03-27 | biosimilar version of etanercept | Intas Pharmaceuticals (India) | rheumatoid arthritis juvenile idiopathic arthritis psoriatic arthritis ankylosing spondylitis plaque psoriasis |
Product launch |
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