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Number of results: 2676
Date Compound Product name Company Disease Action mechanism Type of Information
2017-05-18 cariprazine Vraylar® (US)/Reagila® (EU) Allergan (Ireland) Gedeon Richter (Hungary) Recordati (Italy) schizophrenia manic or mixed episodes associated with bipolar I disorder in adults dopamine D3 receptor partial agonist. Cariprazine has been discovered by researchers at Gedeon Richter. This orally active, potent dopamine D3-preferring D3/D2… Positive opinion for the granting of a Market Authorisation in the EU
2017-05-18 brodalumab Kyntheum® (EU)/Siliq® (US) (brodalumab AstraZeneca (UK) Valeant Pharmaceuticals (Canada) Leo Pharma (Denmark) moderate-to-severe plaque psoriasis monoclonal antibody. Brodalumab is a highly-selective human monoclonal antibody that binds to and blocks signaling via the interleukin-17 (IL-17) receptor.… Positive opinion for the granting of a Market Authorisation in the US
2017-05-05 pembrolizumab (MK-3475) Keytruda® Merck&Co (USA - NJ) adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and brentuximab vedotin , or who are transplant-ineligible and have failed brentuximab vedotin monoclonal antibody/immune checkpoint inhibitor. Keytruda® (pembrolizumab - MK-3475) is an investigational, highly selective monoclonal anti-PD-1 antibody designed to restore the natural… Granting of a Market Authorisation in the EU
2017-05-05 edaravone Radicava® Mitsubishi Tanabe Pharma (Japan) amyotrophic lateral sclerosis neuroprotective agent/free radical scavenger Granting of a Market Authorisation in the US
2017-05-03 recombinant adeno-associated viral vector, AAV2 serotype 6 (rAAv2/6), expressing human factor 8 (hf8) cDNA SB-525 Sangamo Therapeutics (USA - CA) previously known as Sangamo Biosciences hemophilia A gene therapy/genome editing product. Sangamo has developed an adeno-associated virus (AAV) carrying a clotting Factor 8 gene construct driven by Sangamo's… Granting of the orphan status in the US
2017-05-03 ibalizumab ibalizumab TaiMed Biologics (USA-CA/Taiwan) 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… Submission of a Market Application in the US
2017-05-02 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… Product launch
2017-05-01 durvalumab Imfinzi® - durvalumab (MEDI4736) AstraZeneca (UK) locally advanced or metastatic urothelial carcinoma monoclonal antibody/immune checkpoint inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from… Granting of a Market Authorisation in the US
2017-04-28 nivolumab Opdivo® BMS (USA - NY) recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy monoclonal antibody/immune chekcpoint inhibitor. Nivolumab is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1… Granting of a Market Authorisation in the EU
2017-04-28 brigatinib Alunbrig® (brigatinib - AP26113) Ariad Pharmaceuticals (USA - MA) now Takeda Pharmaceutical (Japan) patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib kinase inhibitor/tyrosine kinase inhibitor. Brigatinib (AP26113) is an investigational, targeted cancer medicine discovered internally at Ariad Pharmaceuticals. It is in… Granting of a Market Authorisation in the US
2017-04-28 BI-1206 BioInvent (Sweden) monoclonal antibody. BI-1206 is a fully-human anti-CD32b antagonistic antibody that in addition to directly killing tumour cells is thought to work… Granting of a patent
2017-04-27 regorafenib Stivarga® Bayer Healthcare (Germany) hepatocellular carcinoma multi-kinase inhibitor. Stivarga® (regorafenib) is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and… Granting of a Market Authorisation in the US
2017-04-27 cerliponase alfa Brineura™ - BMN 190 BioMarin Pharmaceutical (USA - CA) late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), a form of Batten disease enzyme replacement therapy. Cerliponase alfa is a recombinant human tripeptidyl peptidase 1 (rhTPP1). This enzyme replacement therapy is designed to restore TPP1… Granting of a Market Authorisation in the US
2017-04-26 recombinant human parathyroid hormone Natpara®/Natpar® NPS Pharma UK (UK) NPS Pharmaceuticals (USA - NJ) now Shire (UK - USA)
  • • adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism
  • • adjunctive treatment for adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone
protein. Natpara® is a bioengineered replacement for endogenous parathyroid hormone (PTH) that NPS has developed for the treatment of hypoparathyroidism,… Granting of a Market Authorisation in the EU
2017-04-25 naltrexone HCl and bupropion HCl Contrave© (naltrexone HCl and bupropion HCl) Valeant Pharmaceuticals (Canada) Orexigen Therapeutics (USA - CA) chronic weight management in adults Contrave® is a combination of naltrexone and bupropion, in an extended-release formulation. Naltrexone is approved to treat alcohol and opioid… Acceptation for review of a NDA
2017-04-25 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). Submission of a Market Application in the US
2017-04-24 anti-thymocyte globulin (rabbit) Thymoglobulin® Sanofi (France) prevention of acute rejection in patients receiving a kidney transplant polyclonal antibody Granting of a Market Authorisation in the US
2017-04-21 inotuzumab ozogamicin Besponsa® (inotuzumab ozogamicin) Pfizer (USA - NY) B-cell acute lymphoblastic leukaemia antibody drug conjugate. Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody targeting CD22,a cell surface antigen expressed on… Positive opinion for the granting of a Market Authorisation in the EU
2017-04-21 infliximab biosimilar Flixabi®/Renflexis® - SB2 - (Infliximab-abda) 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. Granting of a Market Authorisation in the US
2017-04-21 trientine tetrahydrochloride Cuprior® GMP Orphan (France) Voisin Consulting (France) Wilson's disease chelating copper agent. Trientine is a copper-chelating agentthat removes copper from the body by forming a stable complex that is then… Positive opinion for the granting of a Market Authorisation in the EU