Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2013-11-20 | (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride | Lumena Pharma UK, now Shire (UK - USA) | primary biliary cirrhosis |
Granting of the orphan status in the EU |
2013-11-20 | (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride | Lumena Pharma UK, now Shire (UK - USA) | Alagille syndrome |
Granting of the orphan status in the EU |
2013-11-20 | (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride | Lumena Pharma UK, now Shire (UK - USA) | primary sclerosing cholangitis |
Granting of the orphan status in the EU |
2016-06-13 | (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride | Lumena Pharma UK, now Shire (UK - USA) | progressive familial intrahepatic cholestasis |
Granting of the Breakthrough Therapy status |
2013-12-18 | fenfluramine hydrochloride | Brabant Pharma Limited (UK) | Dravet’s syndrome | Granting of the orphan status in the EU |
2013-11-20 | humanised monoclonal modified IgG4 antibody with bispecific structure targeting factors IX, IXa, X and Xa | Chugai Pharma Europe Ltd | haemophilia A | |
2013-11-20 | nitric oxide | Novoteris (USA) | cystic fibrosis |
|
2013-11-20 | poly[2-[(4-{[1-carboxy-2-(hexadecylcarbamoyl)ethyl]sulfanyl}-2,3-bis({2-[((2S)-2-(2-{[(2R)-2-carbamoyl-(2-{[(2S)-1-ethoxy-3-(3-hydroxy-4oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}ethyl]sulfanyl}-3-{[(2S)-1-ethoxy-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}propanamido)-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)propanoyl ethyl ester))-methoxy]acetyl}oxy)butyl)sulfanyl]-3-(hexadecylcarbamoyl)propanoic acid]-PEG1500-ester] | Coté Orphan Consulting UK Limited (UK) | dengue | |
2013-11-20 | recombinant human type I pancreatic elastase | Proteon Therapeutics (USA) | prevention of arteriovenous access dysfunction in haemodialysis patients | |
2017-09-22 | cariprazine | Allergan (Ireland) Gedeon Richter (Hungary) Recordati (Italy) |
|
Refusal of a Market Autorisation in the US |
2015-03-26 | sofosbuvir | Gilead Sciences (USA - CA) | chronic hepatitis C in adults | Granting of a Market Authorisation in Japan |
2013-11-25 | Para-aminosalicylic acid | Lucane Pharma (France) | multi-drug resistant tuberculosis | |
2014-10-30 | dapagliflozin/metformin | BMS (USA - NY) AstraZeneca (UK) | type 2 diabetes mellitus in adults as an adjunct to diet and exercise to improve glycaemic control • in patients inadequately controlled on their maximally tolerated dose of metformin alone
• in combination with other glucose lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products (see sections 4.4, 4.5 and 5.1 for available data on different combinations)
• in patients already being treated with the combination of dapagliflozin and metformin as separate tablets. |
Granting of a Market Authorisation in the US |
2013-11-26 | human plasma-derived fibrinogen and thrombin | The Medicines Company (USA) | hemostasis | |
2013-11-26 | H5N1 avian influenza vaccine | GSK (UK) | prevention of H5N1 avian influenza |
Granting of a Market Authorisation in the US |
2013-11-28 | faldaprevir | Boehringer Ingelheim (Germany) | hepatitis C |
Granting of a patent |
2013-11-27 | ofranergene obadenovec | VBL Therapeutics (Israel) | glioblastoma multiforme | Granting of a Fast Track status |
2018-02-27 | monoclonal antibody inhibitor of plasma kallikrein - recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein | Dyax (USA - MA), now Shire (UK - USA) | hereditary angioedema (HAE) | Positive opinion for the granting of a Market Authorisation in the EU |
2013-12-10 | VBL Therapeutics (Israel) | |||
2015-09-10 | oral fixed-dose combination capsule of netupitant 300 mg + palonosetron 0.50 mg (NEPA) | Helsinn (Switzerland) Eisai (Japan) | prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) following both highly and moderately emetogenic chemotherapy |
Product launch |
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