Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2016-07-18 | Proveca (UK) | symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders. |
Positive opinion for the granting of a Market Authorisation in the EU | |
2016-07-21 | Techdow Europe (Sweden) | prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA) treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty blood clot prevention in the extracorporeal circulation during haemodialysis |
Positive opinion for the granting of a Market Authorisation in the EU | |
2016-07-21 | Pharmathen (Greece | prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA) treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty blood clot prevention in the extracorporeal circulation during haemodialysis prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA) treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty blood clot prevention in the extracorporeal circulation during haemodialysis |
Positive opinion for the granting of a Market Authorisation in the EU | |
2017-01-31 | 5-aminolevulinic acid | Biofrontera Bioscience (Germany) | actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2) and of field cancerization | Granting of a Market Authorisation in the EU |
2015-11-04 | cryopreserved human placental tissue | Osiris Therapeutics (USA - MD) | soft tissue repair |
Product launch |
2016-02-02 | cryopreserved placental membrane | Osiris Therapeutics (USA - MD) | chronic wounds |
Reimbursement |
2016-05-31 | dusquetide | Soligenix (USA - NJ) | melioidosis |
Granting of a Fast Track status |
2016-01-06 | 1-(2-Nitro-imidazolyl)-3-[18F]fluoro-2-propanol;1H-1-(3-[18F]fluoro-2-hydroxypropyl)-2-nitroimidazole | Advanced Imaging Projects (USA - Fl) | clinical management of soft tissue sarcoma, including rhabdomyosarcoma |
Granting of the orphan status in the US |
2016-01-20 | 90Y-DOTA-tyr3-Octreotide | Sue O'Dorisio (USA - IA) | neuroendocrine tumors |
Granting of the orphan status in the US |
2016-01-27 | bevacizumab and erlotinib | Genentech, a member of Roche Group (USA - CA - Switzerland) | mesothelioma | Granting of the orphan status in the US |
2016-01-06 | dendritic-cell targeting, lentiviral vector encoding the NY-ESO-1 gene | Immune Design (USA - WA) | soft tissue sarcoma | Granting of the orphan status in the US |
2016-01-21 | endothelin receptor B antagonist | ENB Therapeutics (USA - NY) | malignant melanoma Stages IIB to IV |
Granting of the orphan status in the US |
2018-09-20 | pegfilgrastim - biosimilar version of Neulasta® | Mylan (USA - PA) Biocon (India) |
|
Positive opinion for the granting of a Market Authorisation in the EU |
2016-01-11 | 2',2'-difluorodeoxycytidine | InnoPharmax (Taiwan) | cholangiocarcinoma |
Granting of the orphan status in the US |
2016-01-13 | His-His- Ile-Tyr-Leu-Gly-Ala-Val-Asn-Tyr-Ile-Tyr-NH2 | ONL Therapeutics (USA - NI) | retinal detachment |
Granting of the orphan status in the US |
2016-01-21 | HLA-A2-selective gp100-specific T cell redirector | Immunocore (UK) | uveal melanoma |
Granting of the orphan status in the US |
2016-08-05 | pembrolizumab | Merck&Co (USA - NJ) |
|
Granting of a Market Authorisation in the US |
2016-01-14 | mifepristone | Corcept Therapeutics (USA - CA) | ovarian cancer |
Granting of the orphan status in the US |
2016-01-14 | pembrolizumab (MK-3475) | Merck&Co (USA - NJ) | primary mediastinal B cell lymphoma | Granting of the orphan status in the US |
2016-01-13 | recombinant human serum albumin human growth hormone | Teva Pharmaceuticals (Israel) | growth hormone deficiency |
Granting of the orphan status in the US |
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