| Date | Compound | Laboratory | Indication | Type of Information |
|---|---|---|---|---|
| 2013-05-10 | canakinumab | Novartis (Switzerland) | gouty arthritis attacks |
Granting of a Market Authorisation in the EU |
| 2011-05-06 | everolimus | Novartis (Switzerland) | advanced neuroendocrine tumors (NET) of pancreatic origin | Granting of a Market Authorisation in the US |
| 2011-12-19 | fexofenidine | Sanofi-Aventis (France) Chattem (USA) | relief of symptoms associated with seasonal allergies in patients 12 years of age and older. |
Granting of a Market Authorisation in the USA |
| 2011-12-19 | polyclonal antibody | Fresenius Biotech (Germany) | prophylaxis of graft-versus-host disease (GVHD) for unrelated stem cell transplant donors in adults |
Granting of a Market Authorisation in the EU |
| 2011-12-19 | bevacizumab | Roche (Switzerland) | first-line treatment in combination with capecitabine of patients with metastatic breast cancer in whom treatment with other chemotherapy options, including taxanes or anthracyclines, is not considered appropriate. | Withdrawal of the product |
| 2012-01-30 | axitinib | Pfizer (USA - NY) | advanced renal cell carcinoma |
Granting of a Market Authorisation in the EU |
| 2017-07-21 | belimumab | GSK (UK) Human Genome Sciences (USA) | systemic lupus erythematosus (SLE) | Granting of a Market Authorisation in the US |
| 2011-12-19 | naproxcinod | Nicox (France) | relief of the signs and symptoms of osteoarthritis of the knee and hip in adults |
Granting of a patent |
| 2014-10-20 | budesonide MMX® | Cosmo Pharmaceuticals (Italy) | mild to moderate active ulcerative colitis | Granting of a Market Authorisation in the EU |
| 2011-12-19 | exenatide | Alkermes (USA-Ireland) Amylin Pharmaceuticals (USA) Eli Lilly (USA) | type-2 diabetes in adults |
Granting of a Market Authorisation in the US |
| 2011-12-19 | carglumic acid | Orphan Europe - Recordati group (Italy) | treatment of hyperammoniaemia due to isovaleric acidaemia, methylmalonic acidaemia and propionic acidaemia |
Granting of a patent |
| 2016-07-05 | characterised cultured chondrocytes derived from the patient’s own cartilage and used for autologous chondrocyte implantation | Tigenix (Belgium) | repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults
|
Withdrawal of the product |
| 2012-04-04 | clonidine | BioAlliance Pharma (France) | prevention of radiotherapy-induced oral mucositis in patients with head and neck cancer. |
Granting of the orphan status in the EU |
| 2012-01-09 | Factor XIII Concentrate made from the pooled plasma of healthy donors | CSL Behring (USA) | congenital Factor XIII deficiency | |
| 2018-02-15 | C1 esterase inhibitor | Viropharma (USA), now Shire (UK - USA) |
|
Acceptation for review of a sNDA |
| 2014-01-08 | dapagliflozin | AstraZeneca (UK) BMS (USA) | type 2 diabetes |
Granting of a Market Authorisation in the US |
| 2011-12-19 | mondoBIOTECH (Switzerland) | hepatocellular carcinoma | ||
| 2015-10-22 | rilpivirine | Janssen-Cilag International, a J&J company (USA - NJ) Tibotec Pharmaceuticals J&J (USA) | HIV-1 infection in adults who have never taken HIV therapy (treatment-naïve) HIV-1 infection in patients 12 years of age and older with a viral load ? 100,000 HIV-1 RNA copies/ml |
Positive opinion for the granting of a Market Authorisation in the EU |
| 2011-12-19 | apixaban | BMS (USA - NY) Pfizer (USA - NY) | prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery |
Granting of a Market Authorisation in the US |
| 2011-12-19 | cetuximab | Merck KGaA (Germany) | advanced or metastatic non-small cell lung cancer (NSCLC) with high epidermal growth factor receptor (EGFR) expression. |
Granting of a patent |
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