| Date | Compound | Product name | Company | Disease | Action mechanism | Type of Information |
|---|---|---|---|---|---|---|
| 2013-05-10 | canakinumab | Ilaris® - ACZ885 | Novartis (Switzerland) | gouty arthritis attacks |
monoclonal antibody. Canakinumab is a fully human monoclonal antibody that neutralizes interleukin-1 beta (IL-1 beta). Excessive production of IL-1 beta… | Granting of a Market Authorisation in the EU |
| 2011-05-06 | everolimus | Afinitor® | Novartis (Switzerland) | advanced neuroendocrine tumors (NET) of pancreatic origin | mTOR inhibitor. Everolimus is a selective mTOR (mammalian target of rapamycin) inhibitor. mTOR is a key serine-threonine kinase, the activity… | Granting of a Market Authorisation in the US |
| 2011-12-19 | fexofenidine | Allegra® OTC | Sanofi-Aventis (France) Chattem (USA) | relief of symptoms associated with seasonal allergies in patients 12 years of age and older. |
antihistaminic | Granting of a Market Authorisation in the USA |
| 2011-12-19 | polyclonal antibody | ATG-Fresenius S | Fresenius Biotech (Germany) | prophylaxis of graft-versus-host disease (GVHD) for unrelated stem cell transplant donors in adults |
The preparation’s mode of action, which mainly targets activated T-cells, includes complement-mediated cytolysis and apoptotic induction of T-cells and antigen-presenting… | Granting of a Market Authorisation in the EU |
| 2011-12-19 | bevacizumab | Avastin® | 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. | monoclonal antibody. Avastin® is an antibody that precisely targets and inhibits vascular endothelial growth factor (VEGF)for continuous tumour control. Avastin’s… | Withdrawal of the product |
| 2012-01-30 | axitinib | Inlyta® | Pfizer (USA - NY) | advanced renal cell carcinoma |
tyrosine kinase inhibitor/VEGFR inhibitor. Axitinib is an oral and selective inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2, and… | Granting of a Market Authorisation in the EU |
| 2017-07-21 | belimumab | Benlysta® | GSK (UK) Human Genome Sciences (USA) | systemic lupus erythematosus (SLE) | monoclonal antibody. Belimumab is a B Lymphocyte Stimulator (BLyS)-specific inhibitor that blocks the binding of soluble BLyS, a B-cell survival factor,… | Granting of a Market Authorisation in the US |
| 2011-12-19 | naproxcinod | Beprana® | Nicox (France) | relief of the signs and symptoms of osteoarthritis of the knee and hip in adults |
This non-steroidal anti-inflammatory drug (NSAID) is a derivative of naproxen with a nitroxybutyl ester to allow it to also act… | Granting of a patent |
| 2014-10-20 | budesonide MMX® | Cortiment® (Budesonide MMX®)/Uceris® (USA) | Cosmo Pharmaceuticals (Italy) | mild to moderate active ulcerative colitis | corticosteroid. Budesonide MMX® is a locally acting corticosteroid in a novel, patented, oral tablet formulation, which utilizes Cosmo’s proprietary MMX®… | Granting of a Market Authorisation in the EU |
| 2011-12-19 | exenatide | Bydureon® | Alkermes (USA-Ireland) Amylin Pharmaceuticals (USA) Eli Lilly (USA) | type-2 diabetes in adults |
glucagon-like peptide-1 (GLP-1) receptor agonist | Granting of a Market Authorisation in the US |
| 2011-12-19 | carglumic acid | Carbaglu® | 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 | Chondrocelect® | 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
|
cell therapy | Withdrawal of the product |
| 2012-04-04 | clonidine | clonidine Lauriad® | 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 | Corifact® | CSL Behring (USA) | congenital Factor XIII deficiency | substitution therapy | |
| 2018-02-15 | C1 esterase inhibitor | Cinryze® | Viropharma (USA), now Shire (UK - USA) |
|
enzyme inhibitor/C1 esterase inhibitor. The C1 inhibitor protein is required to control the ‘complement’ and ‘contact’ systems, collections of proteins… | Acceptation for review of a sNDA |
| 2014-01-08 | dapagliflozin | Forxiga® (EU)/Farxiga® (USA) | AstraZeneca (UK) BMS (USA) | type 2 diabetes |
Dapagliflozin is the first in a class of novel agents for diabetes that inhibit sodium-glucose cotransporter-2 (SGLT2), a specific target… | Granting of a Market Authorisation in the US |
| 2011-12-19 | DasKloster 0014 | mondoBIOTECH (Switzerland) | hepatocellular carcinoma | DasKloster 0014 is a human peptide, which interferes with pathological inflammation, certain virus infection, fibrosis, and cancer in liver models. | ||
| 2015-10-22 | rilpivirine | Edurant® | 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 |
non-nucleoside reverse transcriptase inhibitor. Rilpivirine is a second-generation non-nucleoside reverse transcriptase inhibitor. It blocks the activity of reverse transcriptase, an enzyme produced… | Positive opinion for the granting of a Market Authorisation in the EU |
| 2011-12-19 | apixaban | Eliquis® | BMS (USA - NY) Pfizer (USA - NY) | prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery |
this anticoagulant agent is a direct factor Xa inhibitor. | Granting of a Market Authorisation in the US |
| 2011-12-19 | cetuximab | Erbitux® | Merck KGaA (Germany) | advanced or metastatic non-small cell lung cancer (NSCLC) with high epidermal growth factor receptor (EGFR) expression. |
IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). Its binding to the EGFR inhibits the activation of the… | Granting of a patent |
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