Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2015-03-13 | asenapine | Actavis (Ireland) | manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10 – 17) |
Granting of a Market Authorisation in the US |
2015-03-16 | vilazodone HCl | Actavis (Ireland) | major depressive disorder (MDD) |
Granting of a Market Authorisation in the US |
2015-04-20 | onabotulinumtoxinA | Actavis (Ireland) | upper limb spasticity |
Granting of a Market Authorisation in the US |
2016-04-28 | recombinant humanized anti-tau antibody | C2N Diagnostics (USA - MO)/ Abbvie (USA - IL) | progressive supranuclear palsy |
Granting of the orphan status in the EU |
2015-07-24 | ombitasvir, paritaprevir and ritonavir | Abbvie (USA - IL) | hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis) | Granting of a Market Authorisation in the US |
2015-03-17 | cholic acid capsules | Retrophin (USA - CA) | patients with bile acid synthesis disorders due to single enzyme defects patients with peroxisomal disorders (including Zellweger spectrum disorders) |
Granting of a Market Authorisation in the US |
2015-08-20 | once-daily single tablet regimen combining emtricitabine 200 mg and tenofovir alafenamide (TAF) 25 mg with rilpivirine 25 mg (R/F/TAF) | Gilead Sciences (USA - CA) | HIV-1 infection in adult and pediatric patients 12 years of age and older |
Acceptation for review of a NDA |
2015-11-19 | single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide (TAF) 10 mg (E/C/F/TAF) | Gilead Sciences (USA - CA) | HIV-1 infection |
Granting of a Market Authorisation in the EU |
2015-06-19 | tetrabenazine | AOP Orphan (Austria) | tardive dyskinesia |
Submission of a Market Application in the EU |
2015-05-15 | sustained release dexamethasone | Ocular Therapeutix (USA - MA) | post-surgical ocular pain |
Submission of an NDA |
2015-07-29 | ondansetron | Galena BioPharma (USA - OR) | prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV) in adult patients prevention of radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV) in adult patients prevention of moderately emetogenic CINV in pediatric patients four years and older |
Product launch |
2015-06-10 | tocilizumab | Genentech, a member of Roche Group (USA - CA - Switzerland) | systemic sclerosis | Granting of the Breakthrough Therapy status |
2015-07-28 | Ultratrace® iobenguane I 131 | Progenics Pharmaceuticals (USA - NY) | treatment of patients with iobenguane-avid metastatic or recurrent pheochromocytoma and paraganglioma |
Granting of the Breakthrough Therapy status |
2015-02-23 | basal insulin peglispro | Eli Lilly (USA -IN) | type 1 and type 2 diabetes |
Granting of a Market Authorisation in the US |
2015-07-27 | eltrapuldencel-T | NeoStem (USA - NY) | stage III recurrent or stage IV metastatic melanoma |
Granting of a patent |
2015-08-05 | biosimilar rituximab - biosimilar version of Mabthera®/Rituxan® | Hetero Group (India) | non-Hodgkin lymphoma (NHL) chronic lymphocytic leukaemia (CLL) |
Product launch |
2015-08-13 | plasma-derived, highly purified concentrate of freeze-dried human von Willebrand factor (VWF) and coagulation factor VIII (FVIII) | Octapharma (Switzerland) | prevention of excessive bleeding during and after minor and major surgery in adult and pediatric von Willebrand disease (VWD) patients | Granting of a Market Authorisation in the US |
2016-06-23 | vortioxetine (Lu AA21004) | Lundbeck (Denmark) Takeda Pharmaceutical (Japan) | cognitive dysfunction in adults with Major Depressive Disorder (MDD) | Acceptation for review of a sNDA |
2018-09-20 | paclitaxel | Oasmia Pharmaceutical (Sweden) |
|
Positive opinion for the granting of a Market Authorisation in the EU |
2015-07-07 | Summit Therapeutics (UK) | Duchenne muscular dystrophy |
Granting of a patent |
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