Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2017-08-22 | vedolizumab | Takeda Pharmaceutical (Japan) |
|
Submission of an NDA |
2016-09-23 | recombinant factor VIII Fc fusion protein (rFVIIIFc) - efmoroctocog alfa | BiogenIdec (USA - MA) Swedish Orphan Biovitrum -SOBI (Sweden) | hemophilia A | Reimbursement |
2016-09-16 | technetium Tc 99m tilmanocept | Navidea Biopharmaceuticals (USA - OH) Norgine Pharma (The Netherlands) | imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity |
Positive opinion for the granting of a Market Authorisation in the EU |
2013-03-20 | autologous oral mucosal epithelial cells | CellSeed Europe (UK) | limbal stem cell deficiency (LSCD) | |
2017-06-29 | ceritinib | Novartis (Switzerland) | treatment of patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who had progressed during treatment with, or were intolerant to, crizotinib - first-line treatment of patients with advanced NSCLC whose tumors are ALK+ | Granting of a Market Authorisation in the EU |
2015-09-16 | human normal immunoglobulin | Baxter (USA - IL) | replacement therapy in adults (> 18 years) in primary immunodeficiency syndromes such as: • congenital agammaglobulinaemia and hypogammaglobulinaemia • common variable immunodeficiency • severe combined immunodeficiency • IgG subclass deficiencies with recurrent infections replacement therapy in adults (> 18 years) in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. | Granting of a Market Authorisation in the EU |
2017-08-15 | eculizumab | Alexion Europe (France) |
|
Granting of a patent |
2013-03-27 | ofatumumab | GSK (UK) Novartis (Switzerland) | chronic lymphocytic leukaemia (CLL) in patients who are refractory to fludarabine and alemtuzumab |
Granting of a Market Authorisation in Japan |
2014-08-26 | empagliflozin | Boehringer Ingelheim (Germany) - Eli Lilly (USA - IN) | type 2 diabetes | Product launch |
2013-04-03 | H5N1 adjuvanted pandemic influenza vaccine produced in Vivalis’s EB66® cell line | The Chemo-Sero-Therapeutic Research Institute (Kaketsuken) (Japan) | pandemic influenza |
Granting of a patent |
2016-05-23 | daratumumab | Janssen Research & Development, a J&J company (USA - NJ) Genmab (Denmark) |
|
Granting of a Market Authorisation in the EU |
2013-04-11 | (immune globulin intravenous [human], 10 percent liquid, for intravenous administration | CSL Behring (Australia) | chronic inflammatory demyelinating polyneuropathy (CIDP) |
Granting of a patent |
2013-04-26 | anti-CCP in vitro diagnostic (IVD) kit | Theradiag (France) | rheumatoid arthritis |
Granting of a Market Authorisation in the EU |
2015-12-29 | dipraglurant | Addex Therapeutics (Switzerland) | levodopa-induced dyskinesia associated with Parkinson's disease (PD-LID) |
Granting of the orphan status in the US |
2013-04-26 | XEN402 | Teva Pharmaceutical Industries (Israel) Xenon Pharmaceuticals (USA) | pain associated with erythromelalgia | |
2015-12-16 | elosulfase alfa | BioMarin (USA - CA) | Morquio syndrom (mucopolysaccharidosis type IVA) |
Reimbursement |
2016-12-13 | Matrix applied characterised autologous cultured chondrocytes | Vericel (USA - MA) | repair of symptomatic, full-thickness cartilage defects of the knee in adult patients |
Granting of a Market Authorisation in the US |
2013-04-29 | dextromethorphan hydrobromide and quinidine sulfate | Jenson Pharmaceutical Services (UK) | pseudobulbar affect | |
2015-03-26 | umeclidinium bromide (UMEC) | GSK (UK) Theravance (USA) | chronic obstructive pulmonary disease (COPD) | Granting of a Market Authorisation in Japan |
2013-05-01 | allogeneic bone marrow derived mesenchymal cells expanded ex vivo in synthetic media | Cell2B Advanced Therapeutics (Portugal) | graft-versus-host disease |
Granting of a patent |
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