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Number of results: 2754
Date Compound Product name Company Disease Action mechanism Type of Information
2017-08-16 brentuximab vedotin Adcetris® Takeda Global Research and Development Centre (UK), subsidiary of Takeda Pharmaceutical (Japan) Seattle Genetics (USA - WA)
  • cutaneous T-cell lymphoma (CTCL)
  • CD30-expressing mycosis fungoides (MF)
  • primary cutaneous anaplastic large cell lymphoma (pcALCL)
antibody drug conjugate. Adcetris® (brentuximab vedotin) is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to… Submission of an sNDA
2017-08-15 lifitegrast Xiidra™ Shire (UK-USA) dry eye disease integrin antagonist/LFA-1 antagonist. Lifitegrast, a small-molecule integrin antagonist, was designed in order to treat dry eye disease, and is a preservative-free… Acceptation for review of a NDA
2017-08-07 latanoprostene bunod ophthalmic solution Vesneo® (latanoprostene bunod - previously known as BOL-303259-X and NCX 116) ) Valeant Pharmaceuticals (Canada) reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension prostaglandin analog. Latanoprostene bunod is a nitric oxide-donating prostaglandin F2-alpha analog.  Upon instillation in the eye, latanoprostene bunod is rapidly metabolized… Refusal of a Market Authorisation in the US
2017-08-03 andexanet alfa AndexXa®(US)/ IndexXa™ (EU) Portola Pharmaceuticals (USA - CA) reversing of the anticoagulant effect of direct or indirect factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event or who require urgent or emergent surgery protein. Andexanet alfa, an FDA-designated breakthrough therapy, is a first-in-class recombinant, modified Factor Xa molecule. It is being developed as… Submission of a Market Application in the US
2017-08-03 glecaprevir/pibrentasvir Maviret®(EU)/Mavyret®(US) Abbvie (USA - IL) chronic hepatitis C virus (HCV) infection in adults (genotypes 1-6) 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… Granting of a Market Authorisation in the US
2017-08-02 (S)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)-imidazo[1,5-a]pyrazine-1-yl)-N-(pyridine-2-yl)-benzamide acalabrutinib Acerta Pharma (USA - CA, The Netherlands), now AstraZeneca (UK) mantle cell lymphoma kinase inhibitor/Bruton's tyrisine kinase inhibitor. Acalabrutinib (ACP-196) is a potential best-in-class irreversible oral Bruton's tyrosine kinase (BTK) inhibitor, currently in Phase III development… Acceptation for review of a NDA
2017-08-02 ibrutinib Imbruvica® Pharmacyclics (USA - CA), now Abbvie (USA - IL) chronic graft versus host disease (cGVHD) Bruton tyrosine kinase inhibitor. Ibrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor being jointly developed by Janssen and Pharmacyclics for… Granting of a Market Authorisation in the US
2017-08-02 sirukumab Plivensia™ Janssen-Cilag International, a J&J company (USA - NJ) GSK (UK) moderately to severely active rheumatoid arthritis monoclonal antibody. Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high affinity and specificity for binding to… Negative opinion for the granting of a Market Authorisation in the US
2017-08-01 enasidenib (AG-221/CC-90007) Idhifa® Celgene (USA - NJ) Agios Pharmaceuticals (USA - MA) relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation enzyme inhibitor/isocitrate dehydrogenase inhibitor. AG-221 is an orally available, selective, potent inhibitor of the mutated isocitrate dehydrogenase (IDH) 2 protein, making… Granting of a Market Authorisation in the US
2017-07-31 adeno-associated viral vector type 2 expressing human recombinant retinal pigment epithelial 65KDa protein gene Luxturna™ (voretigene neparvovec - SPK-RPE65) Spark Therapeutics (USA - PA) retinitis pigmentosa due to autosomal recessive RPE65 gene mutations/inherited retinal dystrophy due to biallelic RPE65 mutations gene therapy. Voretigene neparvovec (SPK-RPE65) uses a neutralized virus as a vector, to transport a functional RPE65 gene into the affected… Submission of a Market Application in the EU
2017-07-31 autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor axicabtagene ciloleucel (KTE-C19) Kite Pharma (USA - CA) relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT), diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) cell therapy/immunotherapy product/CAR-T cell therapy. Axicabtagene ciloleucel (KTE-C19) is Kite Pharma's lead product candidate in which a patient's T cells… Submission of a Market Application in the EU
2017-07-31 durvalumab Imfinzi® AstraZeneca (UK) locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy monoclonal antibody/immune checkpoint inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals… Granting of the Breakthrough Therapy status
2017-07-28 hepatitis B vaccine Heplisav-B® Dynavax (USA - CA) immunization against hepatitis B vaccine. Heplisav-B® combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. In Phase… Positive opinion for the granting of a Market Authorisation in the US
2017-07-26 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… Granting of a Market Authorisation in the EU
2017-07-25 brentuximab vedotin Adcetris® Seattle Genetics (USA - MA)
  • consolidation therapy immediately following an autologous stem cell transplant (ASCT) in CD30+ Hodgkin lymphoma (HL) patients at high risk of relapse
antibody drug conjugate. Adcetris® (brentuximab vedotin) is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to… Granting of a Market Authorisation in Canada
2017-07-25 baricitinib (LY3009104) Olumiant® Eli Lilly (USA -IN) Incyte Corporation (USA - DE) rheumatoid arthritis kinase inhibitor/tyrosine kinase inhibitor/janus kinase inhibitor.Baricitinib is a once daily, oral, selective JAK1 and JAK2 inhibitor. There are four known… Submission of an NDA
2017-07-25 certolizumab pegol Cimzia® UCB (Belgium) Dermira (USA - CA) moderate to severe chronic plaque psoriasis monoclonal antibody/TNF alpha inhibitor. Cimzia® is a Fc-free, pegylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha,… Submission of a Market Application in the US
2017-07-24 Lyme borreliosis vaccine VLA15 Valneva (France - Austria) Lyme disease  vaccine. VLA15 is a new hexavalent, protein subunit-based vaccine candidate targeting the Outer Surface Protein A (OspA) of Borrelia, the most… Granting of a Fast Track status
2017-07-24 infliximab Flixabi®/Renflexis® - SB2 - (Infliximab-abda - biosimilar version of infliximab (Remicade®))) Merck&Co (USA - NJ) Samsung Bioepis (Republic of Korea) rheumatic arthritis, adult Crohn's disease, pediatric Crohn's disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, psoriasis monoclonal antibody/biosimilar. SB2 is a biosimilar version of infliximab (reference biologic Remicade®). It is used to treat autoimmune diseases, including rheumatoid arthritis.… Product launch
2017-07-21 belimumab Benlysta® GSK (UK) Human Genome Sciences (USA) systemic lupus erythematosus (SLE) monoclonal antibody. Belimumab is a B Lymphocyte Stimulator (BLyS)-specific inhibitor that blocks the binding of soluble BLyS, a B-cell survival factor,… Granting of a Market Authorisation in the US