Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2014-10-21 | isavuconazonium sulfate | Astellas Pharma (Japan) | invasive candidiasis/candidemia |
Granting of the orphan status in the US |
2014-10-16 | cardiotrophin-1 | Digna Biotech (Spain) | prevention of ischemia-reperfusion injury in kidney transplant recipients |
Granting of the orphan status in the US |
2014-10-22 | human tetravalent, bi-specific monoclonal antibody that binds and co-inhibits two growth factor receptors; insulin-like growth factor receptor 1 (IGF-1R) and v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3 (ErbB3) | Merrimack Pharmaceuticals (USA - MA) | pancreatic cancer |
Granting of the orphan status in the US |
2015-05-21 | triheptanoin | Ultragenyx Pharmaceutical (USA - CA)/ Pharmagateway (Sweden) | glucose transporter type-1 deficiency syndrome/Encephalopathy due to GLUT1 deficiency | Granting of the orphan status in the EU |
2014-10-21 | N-(4-{3-(2-aminopyrimidin-4-yl)pyridin-2-yl]oxy}phenyl)-4-(4-methylthiophen-2-yl)phthalazin-1-amine bis-mesylate dihydrate | Amgen (USA - CA) | ovarian cancer |
Granting of the orphan status in the US |
2014-10-29 | alpha-1 antitrypsin | Kamada (Israel) | graft-versus-host-disease |
Granting of the orphan status in the US |
2015-01-21 | secukinumab | Novartis (Switzerland) | moderate-to-severe plaque psoriasis | Granting of a Market Authorisation in the US |
2017-07-19 | patiromer sorbitex calcium | Relypsa (USA - CA) Vifor Fresenius Medical Care Renal Pharma France (France) | hyperkalemia | Granting of a Market Authorisation in the EU |
2016-03-28 | sebelipase alfa - recombinant human lysosomal acid lipase | Synageva BioPharma (USA - MA), now Alexion Pharmaceuticals (USA - CT) | lysosomal acid lipase deficiency (LAL Deficiency) |
Granting of a Market Authorisation in Japan |
2014-10-20 | Alnylam Pharmaceuticals (USA - MA) | Familial amyloidotic polyneuropathy (FAP) |
Product launch | |
2014-10-22 | Sorin (Italy) | mitral valve disease |
Granting of a Market Authorisation in the EU | |
2014-10-17 | prognostic test | Myriad Genetics (USA - UT) | prostate cancer |
Reimbursement |
2014-11-04 | Covidien (Ireland) | peripheral arterial disease |
Granting of a Market Authorisation in the US | |
2014-10-28 | articulating reloadable fixation device | Covidien (Ireland) | ventral hernia repair |
Product launch |
2014-10-27 | Covidien (Ireland) | Product launch | ||
2014-10-28 | gene engineering platform | GE Healthcare (USA) | Product launch | |
2016-08-08 | pembrolizumab (MK-3475) | Merck&Co (USA - NJ) |
|
Granting of a Market Authorisation in the EU |
2014-10-24 | carbamazepine | Lundbeck (Denmark) | replacement therapy in adults who are on a stable maintenance oral dose of carbamazepine to control certain seizure types, when oral carbamazepine administration is temporarily not feasible and is expected to have a similar safety profile to oral carbamazepine |
Negative opinion for the granting of a Market Authorisation in the US |
2014-10-30 | nevirapine | Mylan (USA - PA) | HIV-1 infection in adults and in children six to less than 18 years of age |
Product launch |
2014-11-05 | Norethindrone Acetate and Ethinyl Estradiol Tablets | Mylan (USA - PA) | oral contraception |
Product launch |
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