Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2013-07-19 | idelalisib | Gilead Sciences (USA - CA) | extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) |
Granting of the orphan status in the EU |
2013-07-19 | idelalisib | Gilead Sciences (USA - CA) | nodal marginal zone lymphoma |
Granting of the orphan status in the EU |
2013-07-19 | idelalisib | Gilead Sciences (USA - CA) | splenic marginal zone lymphoma |
Granting of the orphan status in the EU |
2013-07-19 | lipid-complexed cisplatin | Richardson Associates Regulatory Affairs Ltd (UK) | osteosarcoma |
Positive opinion for the granting of the orphan status in the EU |
2013-07-19 | octreotide acetate (oral use) | Larode Ltd (UK) | acromegaly | |
2018-06-28 | tolvaptan | Otsuka Pharmaceutical (Japan) | autosomal dominant polycystic kidney disease | Granting of a Market Authorisation in the EU |
2013-07-19 | trans-N1-((1R,2S)-2-phenylcyclopropyl)cyclohexane-1,4-diamine bis-hydrochloride | Oryzon Genomics (Spain) | acute myeloid leukaemia |
|
2013-07-19 | (1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-2-yl)-Beta-Dgalactopyranosyl]-4-O-(alpha-L-fucopyranosyl)-5-orothylamido-cyclohexane-1-carboxylic acid ethyl-2-amidyl-ethyloxy-2-acetyl-(8-amino-1,3,6-naphthalene-tris sodium sulfonate) amide | Pfizer (USA - NY) | sickle cell disease |
Granting of a patent |
2013-07-19 | apremilast | Celgene (USA) | Behçet’s disease |
Granting of the orphan status in the EU |
2018-01-08 | budesonide | Dr Falk Pharma GmbH (Germany) | eosinophilic oesophagitis in adults | Granting of a Market Authorisation in the EU |
2013-07-19 | chimeric monoclonal antibody against claudin-18 splice variant 2 | GANYMED Pharmaceuticals (Germany) | pancreatic cancer | |
2013-07-19 | cladribine | Lipomed GmbH (germany) | mastocytosis | Granting of the orphan status in the EU |
2014-01-10 | human allogeneic bone marrow derived osteoblastic-like cells | Bone Therapeutics (Belgium) | nontraumatic osteonecrosis |
Granting of the orphan status in the US |
2013-07-19 | pegylated recombinant anti-Pseudomonas aeruginosa PcrV Fab' antibody | KaloBios (USA) | Pseudomonas aeruginosa lung infection in cystic fibrosis |
Granting of a patent |
2013-07-19 | recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains | Larode (UK) | growth hormone deficiency |
|
2013-07-19 | sacrosidase | QOL Therapeutics EU Ltd (UK) | congenital sucrase-isomaltase deficiency | |
2013-07-22 | peginterferon beta-1a | BiogenIdec (USA - MA) | relapsing forms of multiple sclerosis |
Granting of a Market Authorisation in the US |
2013-07-26 | levomilnacipran (1S, 2R-milnacipran) | Pierre Fabre Medicament (France) Forrest Laboratories (USA) | major depressive disorder (MDD) | |
2016-03-31 | filgrastim - biosimilar version of recombinant human granulocyte colony stimulating factor (G-CSF) | Apotex Europe (The Netherlands) Apotex (Canada) | * reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) * reduction in the duration of neutropenia in adult patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. *mobilisation of peripheral blood progenitor cells (PBPCs) in adults. In adult patients with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of less than or equal to 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Grastofil® is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. *treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in adults with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate. |
Product launch |
2013-07-26 | alogliptin/pioglitazone | Takeda Pharmaceutical (Japan) | second or third line treatment in adult patients aged 18 years and older with type 2 diabetes mellitus:
- as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance.
-in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone. In addition, Incresync® can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type 2 diabetes mellitus already being treated with this combination.
|
Granting of a Market Authorisation in the EU |
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