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Number of results: 2852
Date Compound Product name Company Disease Action mechanism Type of Information
2018-03-08 delafloxacin Baxdela® (US)/Quofenix®(UE) Melinta Therapeutics (USA - CT)
  • acute bacterial skin and skin structure infections (ABSSSI)
antibiotic. Delafloxacin is an anionic fluoroquinolone antibiotic currently in Phase 3 clinical development for hospital-treated skin infections, known as acute bacterial… Submission of a Market Application in the EU
2018-03-05 prucalopride Resolor® - SHP555 Shire (UK - USA)
  •  symptomatic treatment of chronic constipation in patients whom laxatives fail to provide adequate relief
  • chronic idiopathic constipation
5-HT4 receptor agonist. Prucalopride is a selective, high-affinity 5-HT4 receptor agonist with gastrointestinal prokinetic effects. It binds to and stimulates 5-HT4… Acceptation for review of a NDA
2018-02-28 calaspargase pegol calaspargase pegol (Cal-PEG - SHP663) Shire (UK - USA) acute lymphoblastic leukemia (ALL) enzyme/protein. Calaspargase pegol is an intravenous formulation containing E. coli-derived L-asparaginase II conjugated with succinimidyl carbonate monomethoxypolyethylene glycol (SC-PEG) . L-asparaginase hydrolyzes… Acceptation for review of a NDA
2018-02-27 monoclonal antibody inhibitor of plasma kallikrein - recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein lanadelumab (DX-2930 - SHP643) Dyax (USA - MA), now Shire (UK - USA) hereditary angioedema (HAE) monoclonal antibody. DX-2930 is a novel, fully human monoclonal antibody inhibitor of plasma kallikrein (pKal) and is being developed by… Granting of a Fast Track status
2018-02-26 abemaciclib Verzenio™ - abemaciclib (LY2835219) Eli Lilly (USA -IN)
  • refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer
cell cycle inhibitor/cyclin dependant kinase inhibitor. Abemaciclib (LY2835219) is a cell cycle inhibitor, designed to block the growth of cancer… Granting of a Market Authorisation in the US
2018-02-23 emicizumab (ACE910 - anti-factor IXa x anti-factor X humanized bispecific antibody) Hemlibra® Chugai Pharmaceutical (Japan) Roche (Switzerland) hemophilia A with factor VIII inhibitors  in adult and pediatric patients bispecific antibody. Emicizumab is a bispecific antibody that works by mimicking the coagulation function of factor VIII. Emicizumab was designated as a… Granting of a Market Authorisation in the EU
2018-02-22 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 a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth… Refusal of a Market Autorisation in the EU
2018-02-20 Portola Pharmaceuticals (USA - CA) prevention of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness with risk factors for VTE anticoagulant agent/oral direct Factor Xa inhibitor . Betrixaban is an oral, once-daily Factor Xa inhibitor anticoagulant. It is an FDA-designated Fast… Negative opinion for the granting of a Market Authorisation in the EU
2018-02-16 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
2018-02-15 C1 esterase inhibitor Cinryze® Viropharma (USA), now Shire (UK - USA)
  • treatment and prevention of angioedema attacks in children and adult patients with C1 inhibitor deficiency
enzyme inhibitor/C1 esterase inhibitor. The C1 inhibitor protein is required to control the ‘complement’ and ‘contact’ systems, collections of proteins… Acceptation for review of a sNDA
2018-02-14 opicapone Ongentys® Bial-Portela (Portugal) Neurocrine Biosciences (USA - CA) adjunctive therapy in adult patients with Parkinson’s disease and motor fluctuations enzyme inhibitor/COMT inhibitor. Opicapone is a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor that increases L-DOPA plasma levels when used concomitantly with… Submission of a Market Application in the US
2018-02-13 hydrocortisone oral granules Alkindi® (Infacort®) Diurnal Limited (UK)
  • pediatric adrenal insufficiency (0 through 16 years of age)
hormone/corticosteroid. Infacort® is a preparation of hydrocortisone specifically designed for use in children suffering from adrenal insufficiency . It is an… Granting of a Market Authorisation in the EU
2018-02-13 inter-Alpha-Inhibitor-Proteins (IaIp) inter-Alpha-Inhibitor-Proteins (IaIp) Prometic Life Science (Canada) necrotizing enterocolitis enzyme inhibitor/serine proteases inhibitor. Inter-alpha inhibitor proteins (IaIp) are serine proteases inhibitors that modulate endogenous protease activity. Severe sepsis results… Granting of the orphan status in the US
2018-02-12 ABO-202 (AAV-CLN1) Abeona Therapeutics (USA - NY) infantile Batten disease or infantile neuronal ceroid lipofuscinosis (INCL) gene therapy. ABO-202 program (AAV-CLN1), an AAV-based gene therapy Granting of the orphan status in the US
2018-02-08 semaglutide Ozempic® Novo Nordisk (Denmark) type 2 diabetes glucagon-like Peptide 1 (GLP-1) analogue. Semaglutide is a human GLP-1 (Glucagon-Like Peptide-1) analogue developed for once-weekly treatment of type 2… Granting of a Market Authorisation in the EU
2018-02-07 bictegravir, emtricitabine, tenofovir alafenamide Biktarvy® - 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 novel HIV-1 integrase strand transfer inhibitor (INSTI). Granting of a Market Authorisation in the US
2018-02-01 Clevegen® and Clever-1 antibodies Faron Pharmaceuticals (Finland) monoclonal antibody. Clevegen® is an antibody designed to prevent tumour growth and metastasis which targets the tumour immune suppressor molecule, Clever-1. Clever-1… Granting of a patent
2018-01-30 pegunigalsidase alfa (alpha-galactosidase-A) PRX-102 - pegunigalsidase alfa Protalix BioTherapeutics (Israel) Fabry disease enzyme replacement therapy. Pegunigalsidase alfa is a PEGylated, chemically-modified version of the recombinant alpha-galactosidase-A enzyme, in which the protein sub-units… Granting of a Fast Track status
2018-01-29 FP-1201-lyo (the lyophilised form of Traumakine® (human recombinant interferon-beta 1a) Traumakine® Faron Pharmaceuticals (Finland) acute respiratory distress syndrome (ARDS) protein. FP-1201 is a human recombinant interferon-beta 1a. In acute lung injury (ALI) and acute respiratory distress syndrome (ARDS), the predominant patho-physiological result… Granting of a Fast Track status
2018-01-26 [177]Lutetium-DOTA[0]-Tyr[3]-Octreotate/lutetium (177Lu) oxodotreotide Lutathera® Advanced Accelerator Applications (France) now Novartis (Switzerland) gastro entero pancreatic neuroendocrine tumors (GEP-NETs) peptide/radiopharmaceutical product. Lutathera®, is a radiolabeled somatostatin analog that selectively targets somatostatin receptors which are over-expressed in some tumor types.… Granting of a Market Authorisation in the US