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Number of results: 2877
Date Compound Product name Company Disease Action mechanism Type of Information
2018-09-15 fremanezumab Ajovy ® (fremanezumab -TEV-48125 -formerly LBR-101/ RN-307) Teva Pharmaceuticals (Israel) migraine monoclonal antibody. TEV -48125 (formerly LBR-101/ RN-307) is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a well-validated target… Granting of a Market Authorisation in the US
2018-09-14 ibalizumab Trogarzo™ TaiMed Biologics (Taiwan) Theratechnologies (Canada)
  • HIV-1 infection in treatment experienced adult patients with documented multi-antiretroviral class resistance and evidence of HIV-1 replication despite ongoing antiretroviral therapy
monoclonal antibody. Ibalizumab is a CD4-directed HIV entry-inhibitor and is the first humanized monoclonal antibody in clinical trials for the treatment of… Acceptation for review of a NDA
2018-09-13 moxetumomab pasudotox Lumoxiti® AstraZeneca (UK)
  • relapsed or refractory hairy cell leukemia (HCL)
antibody drug conjugate. Moxetumomab pasudotox is a CD22 immunotoxin composed of a binding portion of an anti-CD22 antibody fused to… Granting of a Market Authorisation in the US
2018-09-07 cabozantinib Cabometyx™ Exelixis (USA - CA) Ipsen (France) advanced renal cell carcinoma tyrosine kinase inhibitor.  Cabozantinib is a kinase inhibitor that blocks abnormal kinase proteins involved in the development and growth of… Granting of a Market Authorisation in the EU
2018-09-06 Virtrial (USA - AZ) Product launch
2018-09-05 tisagenlecleucel-T Kymriah® - CTL019 (tisagenlecleucel-T) Novartis (Switzerland)
  • patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse
cell therapy/gene therapy/CAR-T cell therapy. CTL019 is a personalized T cell therapy, which was pioneered by Carl June and his team… Granting of a Market Authorisation in the EU
2018-09-05 PF-06651600 Pfizer (USA - NY) alopecia areata janus kinase inhibitor/JAK3 inhibitor. PF-06651600, a newly discovered potent JAK3-selective inhibitor, is highly efficacious at inhibiting ?c cytokine signaling, which is… Granting of the Breakthrough Therapy status
2018-09-03 caplacizumab Cablivi® Ablynx (Belgium), now Sanofi (France) acquired thrombotic thrombocytopenic purpura (aTTP) nanobody. Caplacizumab is a bivalent anti-von Willebrand Factor (vWF) Nanobody. vWF is implicated in thrombotic thrombocytopenic purpura (TTP), a rare… Granting of a Market Authorisation in the EU
2018-08-31 tislelizumab tislelizumab (BGB-A317) Beigene (China) relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL) monoclonal antibody/immune checkpoint inhibitor/immunomodulator. Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known… Acceptation for review of a NDA
2018-08-29 triheptanoin UX007 - triheptanoin Ultragenyx Pharmaceutical (USA - CA) long-chain 3-hydroxyacyl-coA dehydrogenase deficiency triglyceride. Triheptanoin is a purified, pharmaceutical-grade, specially designed synthetic triglyceride compound created via a multi-step chemical process. Triheptanoin is metabolized… Submission of an NDA
2018-08-27 volanesorsen - phosphorothioate oligonucleotide targeted to apolipoprotein C-III Waylivra™ Isis USA Ltd (UK) Isis Pharmaceuticals (USA - CA) Akcea Therapeutics (USA - MA) familial chylomicronaemia syndrome (FCS) antisense oligonucleotide. Phosphorothioate oligonucleotide targeted to apolipoprotein C-III (ISIS-APOCIIIRxSIS-APOCIIIRx) is an antisense drug that targets apoC-III, a protein produced in… Refusal of a Market Autorisation in the US
2018-08-27 autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor Yescarta™ - axicabtagene ciloleucel - KTE-C19) Kite Pharma, a Gilead company (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… Granting of a Market Authorisation in the EU
2018-08-27 cytarabine and daunorubicin liposome injection Vyxeos™ Jazz Pharmaceuticals (Ireland) acute myeloid leukemia antimetabolite/antimitotic agent/cytotoxic agent. Vyxeos® is an advanced liposomal formulation that delivers a fixed-ratio (1:5) of daunorubicin and cytarabine. Daunorubicin has… Granting of a Market Authorisation in the EU
2018-08-27 vestronidase alfa-vjbk Mepsevii® Ultragenyx Pharmaceutical (USA - CA) mucopolysaccharidosis 7 (MPS 7, Sly syndrome) enzyme replacement therapy. Mucopolysaccharidosis 7 is caused by a deficiency of the lysosomal enzyme beta-glucuronidase, which is required for the breakdown… Granting of a Market Authorisation in the EU
2018-08-13 omalizumab Xolair® Roche (Switzerland) food allergies monoclonal antibody. Omalizumab is a monoclonal antibody binding to immunoglobulin E (IgE). It suppresses histamine-induced skin reactions, probably through its… Granting of the Breakthrough Therapy status
2018-08-10 patisiran (ALN-TTR02) Onpattro™ (ALN-TTR02) Alnylam Pharmaceuticals (USA - MA) Sanofi (France)
  • transthyretin (TTR)-familial amyloid polyneuropathy (FAP)
  • hereditary transthyretin-mediated amyloidosis
RNAi/siRNA. Patisiran is an investigational RNAi therapeutic targeting transthyretin (TTR). It is designed to target and silence specific messenger RNA, potentially blocking… Granting of a Market Authorisation in the US
2018-08-10 migalastat (1-deoxygalactonojirimycin hydrochloride) Galafold® Amicus Therapeutics (USA - NJ) Fabry disease chaperone/enzyme inhibitor. Migalastat HCI is an orally-administered pharmacological chaperone developed for the treatment of Fabry disease. Fabry disease is an… Granting of a Market Authorisation in the US
2018-08-07 encorafenib in combination with binimetinib and cetuximab Braftovi® in combination with Mektovi®and cetuximab Array BioPharma (USA - CO) Pierre Fabre Médicament (France)
  • BRAFV600E-mutant metastatic colorectal cancer (mCRC)
kinase inhibitor/RAF kinase inhibitor/MEK (MAP kinase) inhibitor. The RAS/RAF/MEK/ERK pathway regulates several key cellular activities including proliferation, differentiation, migration, survival and angiogenesis.… Positive opinion for the granting of a Market Authorisation in the EU
2018-08-07 synthetic stereopure antisense oligonucleotide specific for human dystrophin pre-messenger ribonucleic acid (mRNA) WVE-210201 Wave LIfe Sciences (USA - MA) Duchenne muscular dystrophy antisense oligonucleotide. WVE-210201 is an investigational stereopure oligonucleotide that has been shown to induce skipping of exon 51 of dystrophin pre-mRNA… Granting of the orphan status in the US
2018-07-31 neratinib Nerlynx® (PB272) Puma Biotechnology (USA - CA)
  • extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with trastuzumab (Herceptin®)-based adjuvant therapy
kinase inhibitor/tyrosine kinase inhibitor. PB272 (neratinib) is an irreversible pan-erythroblastic leukaemia viral oncogene homolog (ERBB) tyrosine kinase inhibitor. It blocks mitogenic… Positive opinion for the granting of a Market Authorisation in the EU