Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2014-07-29 | rilotumumab | Amgen (USA) | gastric cancer |
Granting of the orphan status in the EU |
2014-06-23 | riociguat | Bayer HealthCare (Germany) | systemic sclerosis |
Granting of the orphan status in the EU |
2014-06-23 | synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues | Alnylam UK (UK), Alnylam Pharmaceuticals' subsidiary (USA - MA) | haemophilia B
|
Granting of the orphan status in the EU |
2014-06-23 | synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues | Alnylam UK (UK), Alnylam Pharmaceuticals' subsidiary (USA - MA) | haemophilia A |
Granting of the orphan status in the EU |
2014-06-24 | carglumic acid | Orphan Europe - Recordati group (Italy) | organic acidemias |
Granting of the orphan status in the USA |
2014-06-30 | sucroferric oxyhydroxide (mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches) | Vifor Fresenius Medical Care Renal Pharma France (France) | control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD) |
Positive opinion for the granting of a Market Authorisation in the EU |
2014-06-30 | bevacizumab | Roche (Switzerland) | treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents | Granting of a Market Authorisation in the EU |
2017-07-24 | Cellectis (France) |
|
Granting of a patent | |
2015-05-01 | codeine polistirex and chlorpheniramine polistirex | Vernalis (UK) Tris Pharma (USA - NJ) | acute treatment of cough cold | Granting of a Market Authorisation in the US |
2015-11-20 | idarucizumab | Boehringer Ingelheim (Germany) | specific antidote for Pradaxa® - reversion of the anticoagulant effect of dabigatran due to uncontrolled life-threatening bleeding requiring urgent intervention or a need to undergo an emergency surgery/urgent invasive procedure. |
Granting of a Market Authorisation in the EU |
2014-06-30 | etanercept | Pfizer (USA - NY) | treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). |
Positive opinion for the granting of a Market Authorisation in the EU |
2014-06-30 | aflibercept | Bayer Healthcare (Germany) Regeneron Pharmaceuticals (USA - NY) | visual impairment due to diabetic macular edema (DME) |
Granting of a Market Authorisation in the EU |
2014-06-30 | raltegravir | Merck&Co (USA) | treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, children, toddlers and infants from the age of 4 weeks in combination with other anti-retroviral medicinal products |
Positive opinion for the granting of a Market Authorisation in the EU |
2017-12-22 | nilotinib | Novartis (Switzerland) | Philadelphia-chromosome-positive chronic myelogenous leukaemia (CML) | Granting of a Market Authorisation in the EU |
2015-02-06 | bortezomib | Janssen-Cilag International - a J&J company (USA - NJ) | mantle cell lymphoma |
Granting of a Market Authorisation in the EU |
2014-06-30 | long-acting CTP-enhanced human growth hormone (hGH-CTP) | OPKO Health (USA) | growth hormone deficiency |
Granting of a patent |
2014-07-02 | phenylephrine hydrochloride | Flamel Technologies (France) | clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia |
Granting of a Market Authorisation in the USA |
2017-07-13 | lumacaftor and ivacaftor | Vertex Pharmaceuticals (USA - MA) | cystic fibrosis |
Product launch |
2014-06-25 | clofazimine | Novartis (Switzerland) | active tuberculosis |
Granting of the orphan status in the US |
2016-06-02 | humanized anti-IL-6R receptor neutralizing IgG2 monoclonal antibody | Chugai Pharma USA, a member of Roche group (Switzerland) | neuromyelitis optica |
Granting of the orphan status in the EU |
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