Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2015-10-28 | valsartan oral solution | Carmel Biosciences (USA - GA) | hypertension in pediatric patients 0 through 16 years of age |
Granting of the orphan status in the US |
2015-10-29 | N\'-(7-Chloroquinolin-4-yl)-N,N-diethyl-propane-1,3-diamine | Donald J. Krogstad (USA) | malaria |
Granting of the orphan status in the US |
2015-09-15 | mononuclear enriched fraction of human umbilical cord blood | Saneron CCEL Therapeutics (USA – Fl) | amyotrophic lateral sclerosis (ALS) |
Granting of the orphan status in the US |
2015-10-07 | mixture of 2 anti-rabies humanized monoclonal immunoglobulin (Ig)G1k antibodies | Synermore Biologics (Taiwan) | post-exposure prophylaxis against rabies virus infection
|
Granting of the orphan status in the US |
2015-10-09 | everolimus ointment | Aucta Pharmaceuticals (USA – NJ) | tuberous sclerosis complex-related skin lesions |
Granting of the orphan status in the US |
2016-04-21 | interleukin-1 receptor antagonist anakinra | Swedish Orphan Biovitrum (Sweden) | Still's disease including systemic juvenile idiopathic arithritis and adult-onset Still's disease |
Granting of a patent |
2015-10-09 | immunoglobulin G degrading enzyme of Streptococcus pyogenes | Hansa Medical (Sweden) | prevention of antibody mediated organ rejection in solid organ transplant
|
Granting of the orphan status in the US |
2015-10-22 | deflazacort | Marathon Pharmaceuticals (USA – IL) | pediatric (0 through 16 years of age) juvenile idiopathis arthritis (JIA) |
Granting of the orphan status in the US |
2015-10-14 | human soluble receptor-Fc fusion protein that targets human activin A | Atara Biotherapeutics (USA – CA) | ovarian cancer | Granting of the orphan status in the US |
2015-10-29 | dabrafenib and trametinib | Novartis (Switzerland) | patients with BRAF mutation positive non-small cell lung cancer |
Granting of the orphan status in the US |
2017-06-27 | etanercept biosimilar | Sandoz (Switzerland) | rheumatoid arthritis, psoriasis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, paediatric plaque psoriasis | Granting of a Market Authorisation in the EU |
2015-12-02 | mepolizumab | GSK (UK) |
|
Positive opinion for the granting of a Market Authorisation in the EU |
2015-10-06 | angiotensin | Tarix Orphan (USA - MA) | Duchenne muscular dystrophy (DMD) |
Granting of a Fast Track status |
2015-08-18 | angiotensin | Tarix Orphan (USA - MA) | Marfan Syndrome |
Granting of a patent |
2017-02-28 | deutetrabenazine | Teva Pharmaceutical Industries (Israel) | tardive dyskinesia | Acceptation for review of a NDA |
2017-05-30 | allogeneic human primary T-Cells that are engineered to be T-Cell Receptor (TCR)-deficient and express a Chimeric Antigen Receptor (CAR) | Celyad previously known as Cardio3Bioscience (Belgium) | Granting of a patent | |
2015-11-05 | bendamustine oral doseage formulation | Exinda Theapeutics (USA - CA) | chronic lymphocytic leukemia |
Granting of the orphan status in the US |
2016-02-17 | arsenic trioxide capsule (oral) | Orsenix Holdings (The Netherlands) | acute promyelocytic leukemia acute myeloid leukemia |
Granting of the orphan status in the EU |
2015-11-03 | cisplatin | Privo Technologies (USA - MA) | anatomically accessible oral cancers (lip, tongue, gum, floor of mouth, salivary gland, and other oral cavity) |
Granting of the orphan status in the US |
2015-11-03 | human cystic fibrosis transmembrane conductance regulator (hCFTR) messenger RNA (mRNA) complexed with branched polyethyleneimine (bPEI) | Shire (UK - USA) | cystic fibrosis |
Granting of the orphan status in the US |
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