Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2015-07-28 | synthetic double-stranded (hybridized duplex) ribonucleic acid oligonucleotide specific to hydroxyacid oxidase 1 gene | Dicerna Pharmaceuticals (USA - MA) | primary hyperoxaluria type 1 |
Granting of the orphan status in the EU |
2015-05-04 | tacrolimus | Stanford University School of Medicine (USA - CA) | pulmonary arterial hypertension |
Granting of the orphan status in the US |
2015-03-16 | tacrolimus | Selten Pharma (USA - CA) | pulmonary arterial hypertension |
Granting of the orphan status in the US |
2015-05-04 | tadalafil | Eli Lilly (USA -IN) | Duchenne muscular dystrophy (DMD) |
Granting of the orphan status in the US |
2015-03-16 | tetra-substituted porphyrin derivative containing manganese (III) | Aeolus Pharmaceuticals (USA - CA) | idiopathic pulmonary fibrosis |
Granting of the orphan status in the US |
2015-05-28 | trelagliptin succinate | Takeda Pharmaceutical (Japan) | type 2 diabetes |
Product launch |
2015-05-27 | rifaximin | Salix Pharmaceuticals (USA - NC) | irritable bowel syndrome with diarrhea |
Granting of a Market Authorisation in the US |
2016-09-19 | eluxadoline | Actavis, now Allergan (Ireland) Aptalis Pharma (France) | irritable bowel syndrome with diarrhea |
Granting of a Market Authorisation in the EU |
2015-05-25 | combination topical drug preparation of maxacalcitol and betamethasone butyrate propionate | Chugai Pharmaceutical (Japan) | psoriasis |
Submission of an NDA |
2016-08-31 | crizotinib | Pfizer (USA - NY) | ROS1-positive non-small cell lung cancer |
Granting of a Market Authorisation in the EU |
2015-05-28 | sirolimus | Pfizer (USA - NY) | lymphangioleiomyomatosis |
Granting of a Market Authorisation in the US |
2015-04-28 | poly-CD-PEG-camptothecin | Cerulean Pharma (USA - MA) | metastatic renal cell carcinoma |
Granting of a Fast Track status |
2015-06-19 | 3-{[2,3,5,6-tetrafluoro-3\'-(trifluoromethoxy)biphenyl-4-yl]carbamoyl}thiophene-2-carboxylic acid | Panoptes Pharma (Austria) | non-infectious uveitis |
Granting of the orphan status in the EU |
2015-06-19 | allogeneic ex-vivo-expanded human umbilical cord blood-derived mesenchymal stem cells | PSR Group (The Netherlands) | prevention of bronchopulmonary dysplasia |
Granting of the orphan status in the EU |
2015-06-19 | antisense oligonucleotide directed against TGF-ß2 mRNA | Isarna Therapeutics (Germany) | prevention of scarring post glaucoma filtration surgery (trabeculectomy) |
Granting of the orphan status in the EU |
2015-06-19 | obinutuzumab | Roche (Switzerland) | marginal zone lymphoma | Granting of the orphan status in the EU |
2015-06-19 | synthetic 47-amino-acid N-myristoylated lipopeptide, derived from the preS region of hepatitis B virus | MYR GmbH (Germany) | hepatitis delta virus infection |
Granting of the orphan status in the EU |
2015-06-19 | trehalose | Dr Ulrich Granzer (Germany) | spinocerebellar ataxia |
Granting of the orphan status in the EU |
2016-11-10 | aceneuramic acid extended release (Ace-ER), previously known as sialic acid-extended release (SA-ER; UX001) | Ultragenyx Pharmaceutical (USA - CA) | GNE Myopathy, also known as hereditary inclusion body myopathy (HIBM) |
Withdrawal of a market application in the EU |
2015-06-19 | triheptanoin | Ultragenyx Pharmaceutical (USA - CA) | very long-chain acyl-CoA dehydrogenase deficiency | Granting of the orphan status in the EU |
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