Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2014-06-11 | von Willebrand Factor Human Concentrate | rEVO Biologics (USA), an LFB (Laboratoire français du fractionnement et des biotechnologies) group company (France) | Von Willebrand disease | Granting of the orphan status in the USA |
2015-06-30 | Auxogyn (USA) Merck Serono (Germany) | Product launch | ||
2014-06-13 | gadobutrol | Bayer (Germany) | intravenous use with MRI of the breast to assess the presence and extent of malignant breast disease |
Granting of a Market Authorisation in the US |
2015-06-26 | aflibercept | Regeneron Pharmaceuticals (USA - NY) Bayer (Germany) | macular edema following branch retinal vein occlusion (BRVO) |
Granting of a Market Authorisation in Japan |
2014-06-15 | aflibercept | Bayer Healthcare (Germany) Regeneron Pharmaceuticals (USA) | macular edema following Central Retinal Vein Occlusion (CRVO) |
Granting of a Market Authorisation in the EU |
2015-07-03 | insulin glargine (rDNA origin) injection 300 U/mL | Sanofi (France) | type 1 diabetes type 2 diabetes |
Granting of a Market Authorisation in Japan |
2014-06-19 | Sanofi Pasteur MSD (France) | prevention of anal cancer |
Granting of a Market Authorisation in the EU | |
2014-06-19 | adenovirus delta 24-RGD (oncolytic adenovirus genetically modified) | DNAtrix (USA) | glioblastoma |
Granting of the orphan status in the US |
2017-05-24 | meningococcal B vaccine | Pfizer (USA - NY) | prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B | Granting of a Market Authorisation in the EU |
2015-02-10 | carboxy pyrrolidine hexanoyl pyrrolidine carboxylate | GSK (UK) | AL amyloidosis (primary amyloidosis) |
Granting of the orphan status in the US |
2014-06-23 | marizomib | Richardson Associates Regulatory Affairs Ltd (UK) / Triphase Accelerator Corporation (USA) | plasma cell myeloma/multiple myeloma |
Granting of the orphan status in the EU |
2015-02-10 | recombinant monoclonal antibody to human serum amyloid P component | GSK (UK) | AL amyloidosis (primaryamyloidosis) |
Granting of the orphan status in the US |
2014-06-23 | sodium acetate salt of the synthetic peptide H-D-Ala-Ser-Pro-Met-Leu-Val-Ala-Tyr-Asp-D-Ala-OH | Dr Ulrich Granzer (Germany) - Atox Bio (Israel) | necrotising soft tissue infections |
Granting of the orphan status in the EU |
2014-06-23 | adeno-associated viral vector serotype 9 containing the human cardiac calsequestrin gene | Fondazione Salvatore Maugeri Clinica del Lavoro e della Riabilitazione (Italy) | catecholaminergic polymorphic ventricular tachycardia |
Granting of the orphan status in the EU |
2016-09-19 | cediranib | AstraZeneca (UK) | ovarian cancer |
Withdrawal of a market application in the EU |
2014-06-23 | cysteamine bitartrate | Raptor Pharmaceuticals Europe (The Netherlands) | Huntington’s disease |
Granting of the orphan status in the EU |
0000-00-00 | eculizumab | Alexion Europe (Switzerland) | myasthenia gravis, refractory generalized myasthenia gravis in patients who are anti-acetylcholine receptor (AChR) antibody-positive | Granting of a Market Authorisation in Japan |
2014-07-29 | humanised anti-alphaVbeta 6 monoclonal antibody | BiogenIdec (USA) | idiopathic pulmonary fibrosis |
Granting of the orphan status in the EU |
2014-06-23 | oxytocin | Maïthé Tauber (France) | Prader-Willi syndrome |
Granting of the orphan status in the EU |
2014-06-23 | recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain | IDEA Innovative Drug European Associates (UK) | beta thalassemia intermedia and major |
Granting of the orphan status in the EU |
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