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Number of results: 2915
Date Compound Product name Company Disease Action mechanism Type of Information
2018-11-14 triheptanoin UX007 - triheptanoin Ultragenyx Pharmaceutical (USA - CA)
  • long-chain 3-hydroxyacyl-coA dehydrogenase deficiency
  • long-chain fatty acid oxidation disorders (LC-FAOD)
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
2018-11-13 rVSV-EBOV (Ebola) vaccine candidate V920 (rVSV?G-ZEBOV-GP, live attenuated) Merck&Co (USA - NJ) Ebola Zaire disease vaccine. The rVSV vaccine platform is based on an attenuated strain of vesicular stomatitis virus that has been modified to express an… Submission of a Market Application in the US
2018-11-02 pegfilgrastim - biosimilar version of Neulasta® Udenyca® - CHS-1701 - pegfilgrastim Coherus BioSciences (USA - CA) - ERA Consulting (Germany)
  • reduction of the duration of neutropenia and the occurrence of febrile neutropenia in cancer patients
protein/biosimilar. Udenyca®, formerly CHS-1701, is a biosimilar candidate to pegfilgrastim, a growth-colony-stimulating-factor (G-CSF) designed to decrease the chance of infection as… Granting of a Market Authorisation in the US
2018-11-01 fosfomycin for injection Contepo™ Nabriva Therapeutics (Ireland) complicated urinary tract infections (cUTIs), including acute pyelonephritis antibiotic. Contepo™ (fosfomycin for injection, previously referred to as ZTI-01 and Zolyd) is a novel, potentially first-in-class in the United States,… Submission of a Market Application in the US
2018-10-31 adalimumab - biosimilar version of Humira® Hyrimoz® - biosimilar version of Humira® (adalimumab) Sandoz (Switzerland)
  • plaque psoriasis, rheumatoid arthritis, axial spondyloarthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, polyarticular juvenile idiopathic arthritis, active enthesitis-related arthritis, hidradenitis suppurativa, non-infectious uveitis
biosimilar/monoclonal antibody/TNF alpha inhibitor. Adalimumab is a monoclonal antibody that binds specifically to TNF alpha and blocks its interaction with  cell… Granting of a Market Authorisation in the EU
2018-10-26 secukinumab Cosentyx® (AIN457) Novartis (Switzerland) psoriatic arthritis monoclonal antibody. Secukinumab (AIN457) is a fully human monoclonal antibody being investigated for diseases that affect the immune system. Secukinumab stops… Granting of a Market Authorisation in the EU
2018-10-25 non-replicating, recombinant adeno-associated virus (AAV) serotype 9 (AAV9) vector containing an hCLN2 expression cassette encoding for the soluble lysosomal enzyme tripeptidyl peptidase I (TPP1) RGX-181 RegenXBio (USA - MD) late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease gene therapy. RGX-181 is a non-replicating, recombinant adeno-associated virus (AAV) serotype 9 (AAV9) vector containing an hCLN2 expression cassette encoding for… Granting of the orphan status in the US
2018-10-24 baloxavir marboxil Xofluza® Roche (Switzerland) Shionogi (Japan) influenza antiviral/enzyme inhibitor. Xofluza® is a first-in-class, single-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic… Granting of a Market Authorisation in the US
2018-10-19 tetravalent dengue vaccine Dengvaxia® Sanofi Pasteur (France)
  • prevention of dengue caused by dengue virus serotypes 1, 2, 3 and 4 in people who are between 9 and 45 years old, live in an endemic area and already had a prior dengue virus infection
vaccine Positive opinion for the granting of a Market Authorisation in the EU
2018-10-18 ivacaftor Kalydeco® Vertex Pharmaceuticals (USA - MA)
  • cystic fibrosis for people ages 6 and older and in children ages 2 to 5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R and R117H)
  • cystic fibrosis in children ages 2 and older who have one of 23 residual function mutations in the CFTR gene
  • cystic fibrosis in children ages 2 and older who have one of five residual function mutations that result in a splicing defect in the cystic fibrosis transmembrane conductance regulator (CFTR) gene  (2789+5G— > A, 3272-26A— > G in a combination regimen with tezacaftor 100 mg/ivacaftor 150 mg tablets for the treatment of patients with cystic fibrosis  aged 12 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A?G, S945L, S977F, R1070W, D1152H, 2789+5G?A, 3272-26A?G, and 3849+10kbC?T., 3849+10kbC— > T, 711+3A— > G, and E831X)
CFTR potentiator. Ivacaftor is an oral agent that increases ion-function of activated cell-surface cystic fibrosis transmembrane conductance regulator (CFTR).  The CFTR… Positive opinion for the granting of a Market Authorisation in the EU
2018-10-18 pembrolizumab (MK-3475) Keytruda® Merck&Co (USA - NJ)
  • patients with advanced melanoma who have been previously treated with ipilimumab
  • first-line treatment of advanced melanoma
  • melanoma in adults with lymph node involvement who have undergone complete resection
monoclonal antibody/immune checkpoint inhibitor. Keytruda® (pembrolizumab - MK-3475) is an investigational, highly selective monoclonal anti-PD-1 antibody designed to restore the natural… Positive opinion for the granting of a Market Authorisation in the EU
2018-10-18 coagulation factor VIIa NovoSeven® RT (eptacog alfa) Novo Nordisk (Denmark)
  • prevention and treatment of bleeding episodes in those undergoing surgery or invasive procedures in the following patient groups:
  • -in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX > 5 Bethesda Units (BU)
  • -in patients with congenital haemophilia who are expected to have a high anamnestic response to factor VIII or factor IX administration
  • -in patients with acquired haemophilia
  • -in patients with congenital FVII deficiency
  • -in patients with Glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available
Positive opinion for the granting of a Market Authorisation in the EU
2018-10-18 mexiletine hydrochloride Namuscla® Lupin Europe (Germany) symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders sodium channel inhibitor. Mexiletine reduces skeletal muscle hyperexcitability by blocking sodium channels. Positive opinion for the granting of a Market Authorisation in the EU
2018-10-18 trastuzumab-dkst - biosimilar version of trastuzumab Ogivri® - Zedora® - MYL-1401O Mylan (USA - PA) Biocon (India) Libbs Farmaceutica (Brazil) HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer, HER2-positive advanced gastric cancer biosimilar/monoclonal antibody. MYL-1401O is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers.… Positive opinion for the granting of a Market Authorisation in the EU
2018-10-18 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
2018-10-18 influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated and prepared in cell cultures, of 4 different influenza virus strains (two A subtypes and two B types) Flucelvax® Tetra Seqirus Netherlands, subsidiary of CSL (Australia) prophylaxis of influenza in adults and children from 9 years of age vaccine Positive opinion for the granting of a Market Authorisation in the EU
2018-10-16 talazoparib (BMN 673) Talzenna® Pfizer (USA - NY)
  • deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2?negative locally advanced or metastatic breast cancer
enzyme inhibitor/poly ADP ribose polymerase PARP inhibitor/PARP inhibitor. Talazoparib is a potent and specific inhibitor of PARP 1 and 2 that… Granting of a Market Authorisation in the US
2018-10-15 givosiran givosiran (ALN-AS1) Alnylam Therapeutics (USA - MA) acute hepatic porphyria (AHP) RNAi. Givosiran (ALN-AS1) is a subcutaneously administered, investigational RNAi therapeutic that utilizes Alnylam's proprietary Enhanced Stabilization Chemistry (ESC)-GalNAc-siRNA conjugate delivery… Submission of an NDA
2018-10-12 rivaroxaban Xarelto® Bayer Healthcare (Germany) Janssen Research & Development, a J&J company (USA - NJ)
  • prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic event
anticoagulant agent/oral direct Factor Xa inhibitor Granting of a Market Authorisation in the US
2018-10-05 autologous CD34+ haematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector encoding the human beta A-T87Q-globin gene Lentiglobin® bluebird bio (USA - MA) sickle cell disease - beta-thalassemia major gene therapy/stem cell therapy. Haematopoietic stem cells are taken from the patient. To make this medicine, the cells are modified by… Acceptation for review of a NDA