Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2018-10-18 | trastuzumab-dkst - biosimilar version of trastuzumab | Mylan (USA - PA) Biocon (India) Libbs Farmaceutica (Brazil) | HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer, HER2-positive advanced gastric cancer | Positive opinion for the granting of a Market Authorisation in the EU |
2017-08-03 | human monoclonal antibody inhibitor of mannan-binding lectin-associated serine protease-2 | Omeros (USA - Wn) | IgA nephropathy | Granting of the orphan status in the US |
2017-07-31 | denosumab | Amgen (USA - CA) | glucocorticoid-induced osteoporosis | Submission of an sNDA |
2018-05-16 | biosimilar version of trastuzumab - Herceptin® | Amgen (USA - CA) Allergan (Ireland) | breast cancer, gastric cancer | Granting of a Market Authorisation in the EU |
2018-02-13 | biosimilar version of of trastuzumab - Herceptin® | Teva Pharmaceuticals (Israel) Celltrion (South Korea) |
|
Granting of a Market Authorisation in the EU |
2018-03-22 | evolocumab | Amgen (USA - CA) |
|
Positive opinion for the granting of a Market Authorisation in the EU |
2017-06-13 | mRNA-based prophylactic vaccines | Curevac (Germany) | Granting of a patent | |
2017-07-20 | combination comprising an mRNA vaccine and an anti-PD-1 antibody | Curevac (Germany) | Granting of a patent | |
2017-08-23 | obinutuzumab | Chugai Pharmaceutical, a member of Roche Group (Japan) | CD20-positive B-cell follicular lymphoma | Submission of an NDA |
0000-00-00 | rasagiline mesylate | Takeda Pharmaceutical (Japan) | Parkinson’s disease | Submission of an NDA |
2017-05-09 | larotrectinib - (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate | Loxo Oncology (USA - CT) | solid tumors with NTRK-fusion proteins | Granting of the orphan status in the US |
2017-06-21 | (S)-3-((S)-2-(2-((2,6-difluorophenyl)amino)-2-oxoacetamido)propanamido-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid | Conatus Pharmaceuticals (USA - CA) | primary sclerosing cholangitis | Granting of the orphan status in the US |
2018-07-26 | tezacaftor/ivacaftor combination | Vertex Pharmaceuticals (USA - MA) |
|
Positive opinion for the granting of a Market Authorisation in the EU |
2017-11-10 | biosimilar version of Humira®(adalimumab) - adalimumab-adbm | Boehringer Ingelheim (Germany) |
|
Granting of a Market Authorisation in the EU |
2017-03-02 | cabozantinib | Exelixis (USA - CA) | hepatocellular carcinoma | Granting of the orphan status in the US |
2018-09-20 | eravacycline | Tetraphase Pharmaceuticals (USA - MA) | complicated intra-abdominal infections | Granting of a Market Authorisation in the EU |
2017-08-17 | olaparib | AstraZeneca (UK) | maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy | Granting of a Market Authorisation in the US |
2017-08-25 | rabies immune globulin | Kedrion Biopharma (Italy) Kamada (Israel) | post-exposure prophylaxis of rabies infection | Granting of a Market Authorisation in the US |
2018-06-28 | lesinurad and allopurinol | Ironwood Pharmaceuticals (USA - MA) Gruenenthal (Germany) |
|
Positive opinion for the granting of a Market Authorisation in the EU |
2017-07-13 | antisense oligonucleotide targeting exon 13 in the USH2A gene | ProQR Therapeutics (The Netherlands) | retinitis pigmentosa, including Usher syndrome | Granting of the orphan status in the EU |
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