Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2014-04-15 | tolcapone | SOM Biotech (Spain) | transthyretin amyloidosis (ATTR) | Granting of the orphan status in the US |
2015-01-30 | collagenase Clostridium histolyticum | Auxilium Pharmaceuticals (USA) Swedish Orphan Biovitrum - SOBI (Sweden) | Peyronie’s disease | Granting of a Market Authorisation in the EU |
2015-07-16 | atazanavir sulfate and cobicistat | BMS (USA- NY) | HIV-1 infection |
Granting of a Market Authorisation in the EU |
2017-01-04 | empagliflozin and linagliptin | BMS (USA - NY) Eli Lilly (USA - IN) | type 2 diabetes | Granting of a Market Authorisation in the EU |
2014-04-17 | (5R,5aR,8aR,9S)-9-[[4,6-O-[(R)-Ethylidene]-(-D-glucopyranosyl]-oxy]-5-(4-({[(2,2- dimethyl-1,3-dioxolan-4-yl)methoxy]carbonyl}oxy)-3,5-dimethoxyphenyl)-5,8,8a,9- tetrahydroisobenzofuro[5,6-f][1,3]benzodioxol-6(5aH)-one | CellAct Pharma (Germany) | biliary tract cancer |
Granting of the orphan status in the EU |
2014-04-17 | 177Lu-tetraxetan-tetulomab | Nordic Nanovector (Norway) | follicular lymphoma |
Granting of the orphan status in the EU |
2015-05-21 | Lutetium (177Lu) edotreotide | ITG Isotope Technologies Garching GmbH (Germany) | gastro-entero-pancreatic neuroendocrine tumours |
Granting of the orphan status in the US |
2015-03-24 | 4-(4-Methoxy-phenylamino)-6-methylcarbamyl-quinoline-3-carboxylic acid | Clanotech (Sweden) | prevention of scarring post glaucoma filtration surgery |
Granting of the orphan status in the US |
2014-06-04 | adeno-associated viral vector serotype 2 containing the human CHM gene encoding human Rab escort protein 1 | Alan Boyd Consultants (UK) | choroideremia |
Granting of the orphan status in the EU |
2014-04-17 | aganirsen | Gene Signal (France) | central retinal vein occlusion |
Granting of the orphan status in the EU |
2014-04-17 | autologous CD34+ cells transduced with a lentiviral vector containing the human SGSH gene | Cochamo Systems (UK) | mucopolysaccharidosis IIIA (Sanfilippo A syndrome) |
Granting of the orphan status in the EU |
2014-04-17 | autologous dendritic cells pulsed with RNA from glioma stem cells | Epitarget (Norway) | glioma |
Granting of the orphan status in the EU |
2014-06-30 | plasmid DNA encoding the human cystic fibrosis transmembrane conductance regulator gene complexed with a non-viral, cationic lipid based gene transfer agent | Imperial Innovations (UK) | cystic fibrosis |
Granting of the orphan status in the US |
2014-04-17 | paclitaxel-succinate-Arg-Arg-Leu-Ser-Tyr-Ser-Arg-Arg-Arg-Phe | CLL Pharma (France) | glioma |
Granting of the orphan status in the EU |
2014-04-20 | targeted cancer immune therapy (ten synthetic peptides targeting five tumor associated antigens) | OSE Pharma (France) | non- small cell lung cancer (NSCLC) in patients expressing HLA-A2 |
Granting of the orphan status in the US |
2018-09-20 | eteplirsen | Sarepta Therapeutics (USA - MA) | Duchenne Muscular Dystrophy (DMD) amenable to exon 51 skipping | Negative opinion for the granting of a Market Authorisation in the EU |
2014-04-23 | ramucirumab | Eli Lilly (USA - IN) | advanced stomach cancer or gastroesophageal junction adenocarcinoma |
Granting of a Market Authorisation in the US |
2014-04-23 | teriparatide | Entera Bio (Israel) | hypoparathyroidism |
Granting of the orphan status in the US |
2014-04-17 | ciprofloxacin dry powder inhaler | Bayer HealthCare (Germany) | non-cystic fibrosis bronchiectasis |
Granting of a patent |
2015-01-19 | fixed-dose combination of ABT-450 (paritaprevir)/ritonavir (150/100mg) co-formulated with ombitasvir (ABT-267) 25mg, dosed once daily, and dasabuvir (ABT-333) 250mg | Abbvie (USA - IL) | hepatitis C | Granting of a Market Authorisation in the EU |
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