Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2016-05-17 | nivolumab | BMS (USA - NY) | patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin |
Granting of a Market Authorisation in the US |
2016-02-18 | mRNA drug substance | Curevac (Germany) | rabies | Granting of a patent |
2015-12-22 | Oxford Immunotec (UK) | alloreactivity |
Granting of a Market Authorisation in the EU | |
2016-03-23 | tasquinimod | Active Biotech (Sweden) | multiple myeloma |
Granting of a patent |
2016-07-05 | daclizumab high-yield process | Biogen (USA - MA) AbbVie (USA - IL) | relapsing forms of multiple sclerosis | Granting of a Market Authorisation in the EU |
2016-01-29 | rapastinel | Allergan (Ireland) | major depressive disorder (MDD) |
Granting of the Breakthrough Therapy status |
2016-08-29 | cannabidiol | Richardson Associates Regulatory Affairs (UK) | treatment of graft-versus-host Disease (GVHD) |
Granting of the orphan status in the EU |
2016-10-06 | MN-166 (ibudilast) | MediciNova (USA - CA) | amyotrophic lateral sclerosis |
Granting of the orphan status in the US |
2016-09-19 | BI-505 | BioInvent (Sweden) | multiple myeloma |
Granting of a patent |
2017-01-06 | lonoctocog alfa | CSL Behring (Germany) | treatment and prophylaxis of bleeding in patients with hemophilia A | Granting of a Market Authorisation in the EU |
2017-11-10 | padeliporfin di-potassium | Steba Biotech (Luxembourg) | previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy of at least 10 years | Granting of a Market Authorisation in the EU |
2017-07-20 | etirinotecan pegol | Nektar Therapeutics (USA - CA) | advanced breast cancer which has spread to the brain | Negative opinion for the granting of a Market Authorisation in the EU |
2016-12-15 | pembrolizumab | Merck&Co (USA - NJ) | patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test | Positive opinion for the granting of a Market Authorisation in the EU |
2018-03-22 | plitidepsin | Pharmamar (Spain) | relapsed/refractory multiple myeloma | Negative opinion for the granting of a Market Authorisation in the EU |
2016-10-13 | atezolizumab | Genentech, a member of Roche Group (USA - CA - Switzerland) | small cell lung cancer |
Granting of the orphan status in the US |
2017-08-28 | tivozanib - N-{2-Chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-N´-(5-methyl-3-isoxazolyl) urea hydrochloride monohydrate | Aveo Oncology (USA - MA) Eusa Pharma (UK) | first-line treatment of advanced renal cell carcinoma (RCC) | Granting of a Market Authorisation in the EU |
2017-01-06 | insulin glargine (biosimilar version of Lantus®) | Merck&Co (USA - NJ) | diabetes | Granting of a Market Authorisation in the EU |
2018-01-15 | bevacizumab-awwb - biosimilar version of Avastin® | Amgen (USA - CA) Allergan (Ireland) |
|
Granting of a Market Authorisation in the US |
2016-11-16 | amplification kit for ct-DNA (circulating tumor DNA) | Sygnis (Germany) | detection, analysis and monitoring of early tumor stages |
Product launch |
2017-07-25 | brentuximab vedotin | Seattle Genetics (USA - MA) |
|
Granting of a Market Authorisation in Canada |
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