Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2017-07-13 | biosimilar rituximab - biosimilar version of Mabthera®/Rituxan® | Celltrion (Republic of Korea) |
|
Granting of a Market Authorisation in the EU |
2017-07-13 | biosimilar rituximab - biosimilar version of Mabthera®/Rituxan® | Celltrion (Republic of Korea) |
|
Granting of a Market Authorisation in the EU |
2017-12-11 | insulin lispro | Sanofi (France) |
|
Granting of a Market Authorisation in the US |
2017-09-14 | human IgG1 monoclonal antibody specific for human interleukin-1 | XBiotech (USA - TX) | debilitating symptoms of advanced colorectal cancer | Refusal of a Market Autorisation in the EU |
2017-09-29 | insulin aspart | Novo Nordisk (Denmark) | diabetes | Granting of a Market Authorisation in the US |
2017-03-22 | miglustat | JensonR+ Limited (UK) | adult patients with mild to moderate type 1 Gaucher disease | Granting of a Market Authorisation in the EU |
2017-03-23 | pentosan polysulfate sodium | bene-Arzneimittel GmbH (Germany) | bladder pain syndrome characterised by either glomerulations or Hunner’s lesions in the urine bladder mucosa | Positive opinion for the granting of a Market Authorisation in the EU |
2017-03-06 | ataluren - 3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazole-3-yl]-benzoic acid | PTC Therapeutics (USA - NJ) | cystic fibrosis | Withdrawal of a market application in the EU |
2017-04-21 | dimethyl fumarate | Almirall (Spain) | psoriasis | Positive opinion for the granting of a Market Authorisation in the EU |
2018-07-27 | adalimumab - biosimilar version of Humira® | Sandoz (Switzerland) |
|
Granting of a Market Authorisation in the EU |
2018-05-18 | biosimilar version of infliximab (Remicade®) | Sandoz (Switzerland) |
|
Granting of a Market Authorisation in the EU |
2017-04-21 | bevacizumab | Roche (Switzerland) | adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents | Positive opinion for the granting of a Market Authorisation in the EU |
2017-04-21 | maraviroc | ViiV Healthcare (UK - USA) | treatment-experienced adults, adolescents and children of 2 years of age and older and weighing at least 10 kg infected with only CCR5-tropic HIV-1 detectable | Positive opinion for the granting of a Market Authorisation in the EU |
2017-04-04 | nivolumab | BMS (USA - NY) | mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy | Acceptation for review of a sNDA |
2017-06-08 | humanized monoclonal immunoglobulin G1 antibody directed against human CD19 conjugated to SG3199 through a protease cleavable valine-alanine linker | ADC Therapeutics (Switzerland) | mantle cell lymphoma | Granting of the orphan status in the US |
2017-06-08 | humanized monoclonal immunoglobulin G1 antibody directed against human CD19 conjugated to SG3199 through a protease cleavable valine-alanine linker | ADC Therapeutics (Switzerland) | diffuse large B-cell lymphoma | Granting of the orphan status in the US |
2016-05-17 | blood glucose monitoring systems | Ascensia Diabetes Care (Switzerland) | diabetes | Granting of a Market Authorisation in the US |
2017-06-07 | plecanatide | Synergy Pharmaceuticals (USA - NY) | chronic idiopathic constipation (CIC) irritable bowel syndrome with constipation (IBS-C) | Acceptation for review of a sNDA |
2018-06-21 | bictegravir, emtricitabine, tenofovir alafenamide | Gilead Sciences (USA - CA) | HIV-1 infection in adults | Granting of a Market Authorisation in the EU |
2017-06-22 | human C1 esterase Inhibitor | CSL (Australia) | prevention of hereditary angioedema (HAE) attacks in adolescent and adult patients | Granting of a Market Authorisation in the US |
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