Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2017-11-14 | human fibrinogen / human thrombin | Grifols (Spain) | use as a sealant during surgical operations in adults | Granting of a Market Authorisation in the EU |
2017-09-22 | alpha-1 proteinase inhibitor | Grifols (Spain) | alpha-1 antitrypsin deficiency | Granting of a Market Authorisation in the US |
2017-09-28 | remimazolam | Paion (Germany) | Granting of a patent | |
2017-01-04 | pyridopyrimidinone SMN2 splicing modifier | Roche (Switzerland) | spinal muscular atrophy (SMA) | Granting of the orphan status in the US |
2017-04-25 | intranasal tear neurostimulator | Allergan (Ireland) | temporary increase of tear production during neurostimulation in adult patients with aqueous tear deficiency | Granting of a Market Authorisation in the US |
2018-09-03 | caplacizumab | Ablynx (Belgium), now Sanofi (France) | acquired thrombotic thrombocytopenic purpura (aTTP) | Granting of a Market Authorisation in the EU |
2017-09-07 | non-invasive prenatal test for de novo and inherited single-gene disorders | Eurofins Scientifics (Luxembourg) Eurofins Genoma (Italy) | de novo and inherited single-gene disorders | Product launch |
2017-08-31 | Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2 | Vaximm (Germany) | glioma | Granting of the orphan status in the US |
2017-04-25 | Uniqure (The Netherland) | hemophilia B | Granting of the Breakthrough Therapy status | |
2017-09-27 | adeno-associated viral vector serotype 5 encoding a microRNA targeted to human huntingtin gene | Uniqure (The Netherlands) | Huntington's disease | Granting of the orphan status in the US |
2018-09-20 | pegfilgrastim - biosimilar version of Neulasta® | Cinfa Biotech (Spain) | chemotherapy induced neutropenia | Positive opinion for the granting of a Market Authorisation in the EU |
2017-10-19 | CRISPR technology | Merck KGaA (Germany) | Granting of a patent | |
2017-11-09 | dasatinib | BMS (USA - NY) |
|
Granting of a Market Authorisation in the US |
2017-11-13 | revefenacin | Mylan (USA - PA) Theravance (UK) | chronic obstructive pulmonary disease (COPD) | Submission of a Market Application in the US |
2015-02-06 | lecinoxoid | VBL Therapeutics/Vascular Biogenics (Israel) | Granting of a patent | |
2017-10-16 | ofranergene obadenovec | VBL Therapeutics (Israel) | ovarian cancer | Granting of the orphan status in the EU |
2017-11-06 | vemurafenib | Roche (Switzerland) | Granting of a Market Authorisation in the US | |
2018-01-19 | benralizumab | AstraZeneca (UK) |
|
Granting of a Market Authorisation in Japan |
2018-08-27 | vestronidase alfa-vjbk | Ultragenyx Pharmaceutical (USA - CA) | mucopolysaccharidosis 7 (MPS 7, Sly syndrome) | Granting of a Market Authorisation in the EU |
2017-09-12 | SHP607 | Shire (UK - USA) | prevention of chronic lung disease in extremely premature infants | Granting of a Fast Track status |
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