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Number of results: 2737
Date Compound Product name Company Disease Action mechanism Type of Information
2017-06-22 glecaprevir/pibrentasvir Maviret® Abbvie (USA - IL) chronic hepatitis C virus (HCV) infection in adults direct-acting antiviral agent/NS3/4A protease inhibitor/nonstructural protein 5A (NS5A) inhibitor. Maviret® is a fixed dose combination  of two direct acting-antivirals (DAA), glecaprevir… Positive opinion for the granting of a Market Authorisation in the EU
2017-06-22 sofosbuvir, velpatasvir (GS-5816) and voxilaprevir (GS-9857) Vosevi® Gilead Sciences (USA - CA) chronic hepatitis C direct-acting antiviral agent/RNA polymerase (NS5B) inhibitor/ nonstructural protein 5A (NS5A) inhibitor/ NS3/4A protease inhibitor. Vosevi® is a fixed-dose combination of three direct-acting antivirals,… Positive opinion for the granting of a Market Authorisation in the EU
2017-06-22 fulvestrant Faslodex® AstraZeneca (UK) estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women oestrogen receptor antagonist. Faslodex® (fulvestrant) is  an estrogen receptor antagonist indicated for the treatment of postmenopausal women with ER+, locally-advanced or… Positive opinion for the granting of a Market Authorisation in the EU
2017-06-19 CRISPR/Cas9 single-guide gene editing system CRISPR’s in-licensed gene editing technology Crispr Therapeutics (Switzerland - UK) genome editing product Granting of a patent
2017-06-19 nelotanserin nelotanserin Axovant Sciences (USA - NY) visual hallucinations disorder in dementia with Lewy bodies 5-HT2A receptor inverse agonist. Nelotanserin is an investigational drug candidate that has the potential to be a best-in-class, once-daily, orally-administered, potent and… Granting of a Fast Track status
2017-06-15 tirapazamine tirapazamine Teclison (USA - NJ) PhaRA (Belgium) hepatocellular carcinoma cytotoxic agent Positive opinion for the granting of the orphan status in the EU
2017-06-15 oxymetazoline hydrochloride oxymetazoline hydrochloride RDD Pharma (Israel) spinal cord injury Positive opinion for the granting of the orphan status in the EU
2017-06-15 recombinant human antibody directed against misfolded human superoxide dismutase 1 recombinant human antibody directed against misfolded human superoxide dismutase 1 The Medical & Regulatory Partnership (UK) amyotrophic lateral sclerosis Positive opinion for the granting of the orphan status in the EU
2017-06-15 sirolimus sirolimus Raremoon Consulting (UK - USA - MD) pachyonychia congenita immunosuppressive agent Positive opinion for the granting of the orphan status in the EU
2017-06-15 (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4- yl)piperazin-yl)pyrimidin-5-yl)ethan-1-amine (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4- yl)piperazin-yl)pyrimidin-5-yl)ethan-1-amine PhaRA (Belgium) gastrointestinal stromal tumours (GIST) Positive opinion for the granting of the orphan status in the EU
2017-06-15 autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor Celgene (USA - NJ) diffuse large B-cell lymphoma cell therapy/immunotherapy product/gene therapy. Positive opinion for the granting of the orphan status in the EU
2017-06-15 Bacillus subtilis oxalate decarboxylase Bacillus subtilis oxalate decarboxylase Allena Pharmaceuticals (USA - MA) primary hyperoxaluria enzyme. This orally-administered, recombinant oxalate-degrading enzyme targets oxalate in the gastrointestinal tract in an effort to reduce the burden of both… Positive opinion for the granting of the orphan status in the EU
2017-06-15 retinol retinol Orphanix (Austria) prevention of retinopathy of prematurity vitamine Positive opinion for the granting of the orphan status in the EU
2017-06-15 polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1-3)-beta-D-galactopyranoside polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1-3)-beta-D-galactopyranoside SFL Regulatory Affairs Consulting (UK) anti-MAG neuropathy Positive opinion for the granting of a Market Authorisation in the EU
2017-06-15 sildenafil sildenafil Avivia Beheer (The Netnerlands) congenital diaphragmatic hernia phosphodiesterase 5 inhibitor Positive opinion for the granting of the orphan status in the EU
2017-06-13 TK cell therapy Zalmoxis® - TK cell therapy MolMed (Italy) adjunctive treatment in hematopoietic stem cell transplantation (HSCT) for patients affected by high risk leukaemia cell therapy. Zalmoxis® is a cell therapy product, based on the use of genetically engineered donor T cells with a… Granting of a Market Authorisation in the EU
2017-06-12 biosimilar version of pegfilgrastim CHS-1701 - biosimilar version of pegfilgrastim Coherus BioSciences (USA - CA) reduction of the duration of neutropenia and the occurrence of febrile neutropenia in cancer patients protein/biosimilar. Pegfilgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF). Refusal of a Market Autorisation in the US
2017-06-12 bictegravir, emtricitabine, tenofovir alafenamide BIC/FTC/TAF (bictegravir (50 mg) and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) Gilead Sciences (USA - CA) HIV-1 infection in adults integrase inhibitor. Bictegravir is a HIV-1 integrase strand transfer inhibitor (INSTI). Submission of a Market Application in the US
2017-06-12 adenovirus-associated viral vector serotype 5 containing the human RLBP1 gene HORA-RLBP1 Horama (France) retinitis punctata albescens due to RLBP1 gene mutation gene therapy . Retinitis punctata albescens is one type of retinitis pigmentos. The disease is caused by mutations in the RLBP1 gene… 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 ADCT-402 ADC Therapeutics (Switzerland) mantle cell lymphoma antibody drug conjugate. ADCT-402 is a novel antibody-drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19,… Granting of the orphan status in the US