Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2013-07-26 | cobicistat | Gilead Sciences (USA - CA) | pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults |
Submission of a Market Application in the US |
2013-07-26 | alogliptin / metformin | Takeda Pharmaceutical (Japan) | type 2 diabetes mellitus in adults |
Granting of a Market Authorisation in the EU |
2015-04-15 | alogliptin | Takeda Pharmaceutical (Japan) | treatment of adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control |
Granting of a Market Authorisation in the EU |
2013-07-26 | indacaterol / glycopyrronium bromide | Novartis (Switzerland) | maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) |
|
2013-07-26 | delamanid | Otsuka Pharmaceutical (Japan) | multi-drug resistant tuberculosis in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability |
|
2013-07-29 | darunavir | Janssen-Cilag International - a J&J company (USA - NJ) | HIV-1 infection in paediatric patients 12 to 17 years of age |
Granting of a patent |
2013-07-29 | golimumab | Janssen Biologics (J&J - USA) | ulcerative colitis (UC) |
Granting of a patent |
2013-08-16 | dolutegravir | ViiV Healthcare (UK-USA) | HIV-1 infection |
Granting of a Market Authorisation in the EU |
2013-08-16 | Orgenics (Israel) | HIV-1 and HIV-2 infection | ||
2013-08-16 | pazopanib | GSK (UK) | maintenance therapy for advanced ovarian, fallopian tube or primary peritoneal cancer who have not progressed after receiving first-line chemotherapy |
Withdrawal of a market application in the EU |
2013-08-16 | human papillomavirus bivalent (types 16 and 18) vaccine | GSK (UK) | prevention of premalignant genital (cervical, vulvar and vaginal and anal) lesions and cervical and anal cancer causally related to certain oncogenic Human Papillomavirus (HPV) types. |
Submission of a Market Application in the EU |
2013-08-20 | bimagrumab (recombinant human monoclonal antibody against activin receptor type IIB) | Novartis (Switzerland) | sporadic inclusion body myositis (sIBM) |
Granting of the Breakthrough Therapy status |
2013-07-15 | vismodegib | Roche (Switzerland) | basal cell carcinoma |
Granting of a Market Authorisation in the EU |
2016-06-15 | nitisinone | Swedish Orphan Biovitrum (Sobi) (Sweden) | hereditary tyrosinemia type 1 (HT-1) |
Granting of a Market Authorisation in the US |
2013-08-22 | Human papilloma virus type 16 E6/E7 synthetic long peptides | ISA Pharmaceuticals (The Netherlands) | vulvar intraepithelial neoplasia (VIN) | |
2013-09-02 | intranasal formulation of azelastine hydrochloride and fluticasone propionate | Meda (Sweden) | seasonal allergic rhinitis |
Granting of a patent |
2013-09-03 | BL-8040 | BioLineRx (Israel) | acute myeloid leukemia |
Granting of the orphan status in the US |
2017-06-01 | NGR-hTNF | MolMed (Italy) | mesothelioma | Withdrawal of a market application in the EU |
2013-09-11 | PLX-PAD Cells (Placental eXpanded cells) | Pluristem Therapeutics (Israel) | peripheral artery disease | |
2013-09-11 | recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) | CSL Behring (Australia) | congenital factor VII deficiency |
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