Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2012-07-11 | DasKloster 0039 | Mondobiotech (Switzerland) | hepatitis B | |
2015-04-30 | fluticasone furoate and vilanterol | GSK (UK) Theravance (USA - CA) | asthma in 12-17 year old children |
Refusal of a Market Authorisation in the US |
2014-05-23 | laquinimod | Active Biotech (Sweden) | relapsing-remitting multiple sclerosis (RRMS) |
Negative opinion for the granting of a Market Authorisation in the EU |
2017-04-20 | alipogene tiparvovec | uniQure biopharma B.V. [previously Amsterdam Molecular Therapeutics] (The Netherlands) |
|
Withdrawal of a market application in the EU |
2012-07-20 | brentuximab vedotin | Takeda Global Research and Development Centre (UK), subsidiary of Takeda Pharmaceutical (Japan) |
|
Granting of a Market Authorisation in the EU |
2012-07-20 | decitabine | Janssen-Cilag International (J&J - USA) | acute myeloid leukaemia The approved indication is:treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy |
|
2015-10-22 | crizotinib | Pfizer (USA - NY) | treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) |
Positive opinion for the granting of a Market Authorisation in the EU |
2012-07-23 | (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid | Albireo (Sweden) | Alagille syndrome (this syndrome is variably characterized by chronic cholestasis due to paucity of intrahepatic bile ducts, peripheral pulmonary artery stenosis, vertebrae segmentation anomalies, characteristic facies, posterior embryotoxon/anterior segment abnormalities, pigmentary retinopathy, and dysplastic kidneys) | Granting of the orphan status in the EU |
2012-07-23 | (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid | Albireo (Sweden) | primary biliary cirrhosis | Granting of the orphan status in the US |
2012-07-23 | covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes | Astellas Pharma (Japan) | prevention of cytomegalovirus disease in patients with impaired cell mediated immunity deemed at risk | |
2012-07-23 | humanised monoclonal antibody against epidermal growth factor receptor (EGFR) | Abbott (USA) | glioma | |
2017-07-07 | Levoglutamide (L-glutamine) | Emmaus Life Sciences (USA) | sickle cell disease | Granting of a Market Authorisation in the US |
2012-07-24 | humanised monoclonal antibody against P-selectin | Quintiles Ireland | sickle cell disease | |
2012-07-24 | N-Butyldeoxygalactonojirimycin | Actelion (Switzerland) | Fabry disease |
Granting of the orphan status in the EU |
2012-07-24 | trabedersen | Antisense Pharma, now Isarna Therapeutics (Germany) | malignant melanoma | |
2012-07-24 | recombinant anti-CD3-bi-single-chain-Fv-diphtheria toxin fusion protein | AOP Orphan Pharmaceuticals (Austria) | peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated) | |
2016-05-13 | elotuzumab - BMS-90160 | BMS (USA - NY) Abbvie (USA - IL) | multiple myeloma |
Granting of a Market Authorisation in the EU |
2012-07-24 | ketoconazole | Agenzia Industrie Difesa-Stabilimento Chimico Farmaceutico Militare (Italy) | Cushing's syndrome | |
2012-07-24 | recombinant anti-CD3-bi-single-chain-Fv-diphtheria toxin fusion protein | AOP Orphan Pharmaceuticals AG (Austria) | cutaneous T-cell lymphoma | |
2012-07-24 | trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt | Novartis (Switzerland) | familial chylomicronaemia |
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