close

Products

1 3 4 5 6 7 146
Number of results: 2915
Date Compound Product name Company Disease Action mechanism Type of Information
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 (hATTR)
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
2018-08-08 daratumumab Darzalex® Janssen Biotech, a J&J company (USA - NJ) split dosing regimen monoclonal antibody. Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma.… Submission of an sNDA
2018-08-08 omadacycline omadacycline Paratek Pharmaceuticals (USA - MA) acute bacterial skin and skin structure infections (ABSSSI) (17-1) and community-acquired bacterial pneumonia (CABP) (14-4) antibiotic. Omadacycline is a once-daily oral and IV, well-tolerated broad spectrum investigational antibiotic being developed for use as empiric monotherapy for… Positive opinion for the granting of a Market Authorisation in the US
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
2018-08-07 replication-incompetent, non-integrating Herpes simplex type 1 (HSV-1) vector expressing the human transglutaminase-1 (TGM-1) enzyme KB105 Krystal Biotech (USA - PA) TGM-1-deficient autosomal recessive congenital ichthyosis (ARCI) gene therapy. KB105  is a replication-defective, non-integrating viral vector that has been engineered employing Krystal’s STAR-D platform to deliver functional human… Granting of the orphan status in the US
2018-07-30 brexpiprazole - 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one Rexulti®/Rxulti® Lundbeck (Denmark) Otsuka Pharmaceutical (Japan) schizophrenia psychotropic. Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D2 receptors… Granting of a Market Authorisation in the EU
2018-07-30 erenumab Aimovig® Amgen (USA - CA) Novartis (Switzerland) migraine monoclonal antibody. AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine. AMG 334 inhibits… Granting of a Market Authorisation in the EU
2018-07-30 trastuzumab (biosimilar product) Trazimera® Pfizer (USA - NY)
  • human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
biosimilar/monoclonal antibody. Trastuzumab is a recombinant humanized monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER2). After binding… Granting of a Market Authorisation in the EU
2018-07-26 trametinib in combination with dabrafenib trametinib (Mekinist®) in combination with dabrafenib (Tafinlar®) Novartis (Switzerland)
  • unresectable or metastatic melanoma with a BRAF V600 mutation
  • adjuvant treatment of patients with stage III melanoma with BRAF V600E or V600K mutations
kinase inhibitor/RAF kinase inhibitor/MEK (MAP kinase) inhibitor. Dabrafenib is a selective inhibitor of BRAF protein kinase carrying V600E mutation. This orally bioavailable inhibitor… Positive opinion for the granting of a Market Authorisation in the EU
2018-07-26 blinatumomab Blincyto™ Amgen (USA - CA)
  • Philadelphia -negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL)
monoclonal antibody/BiTE® antibody. Blinatumomab is an investigational BiTE® antibody designed to direct the body's cell-destroying T cells against target cells expressing… Positive opinion for the granting of a Market Authorisation in the EU
2018-07-26 biosimilar epoetin alfa Binocrit® Sandoz (Switzerland)
  • anemia associated with chronic kidney disease
  • anaemia and reduction of transfusion requirements in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient’s general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy)
  • predonation programme to increase the yield of autologous blood
  • non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions
  • symptomatic anaemia in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS)
erythropoiesis-stimulating agent/biosimilar. This biosimilar product is a erythropoiesis-stimulating agent. Positive opinion for the granting of a Market Authorisation in the EU
2018-07-26 abaloparatide Eladynos®/Tymlos® Radius Health (USA - MA) postmenopausal women with osteoporosis at high risk for fracture peptide. Abaloparatide-SC is a novel 34–amino acid peptide  similar to part of the human parathyroid hormone. It has been created to… Refusal of a Market Autorisation in the EU
2018-07-26 tezacaftor/ivacaftor combination Symkevi®(UE)/Symdeko® (USA) in combination with ivacaftor Vertex Pharmaceuticals (USA - MA)
  • people with cystic fibrosis (CF) ages 12 and older who have two copies of the F508del mutation or one F508del mutation and one residual function mutation that is responsive to tezacaftor/ivacaftor
CFTR potentiator. Kalydeco® (ivacaftor) is a potentiator of the CFTR protein. The CFTR protein is a chloride channel present at the… Positive opinion for the granting of a Market Authorisation in the EU
2018-07-26 betrixaban Bevyxxa®(US)/Dexxience® (UE) Portola Pharmaceuticals (USA - CA) prevention of venous thromboembolism (VTE) anticoagulant agent/oral direct Factor Xa inhibitor . Betrixaban is an oral, once-daily Factor Xa inhibitor anticoagulant. It blocks this protein which… Negative opinion for the granting of a Market Authorisation in the EU
2018-07-26 biosimilar epoetin alfa Abseamed® Medice Arzneimittel Pütter GmbH & Co (Germany)
  • *symptomatic anaemia associated with chronic renal failure (CRF):
  • - in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis
  • - in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients *anaemia and reduction of transfusion requirements in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient’s general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy)
  • * predonation programme to increase the yield of autologous blood. *non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions
  • * symptomatic anaemia (haemoglobin concentration of ? 10 g/dl) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (< 200 mU/ml)
erythropoiesis-stimulating agent/biosimilar. This biosimilar product is a erythropoiesis-stimulating agent. Positive opinion for the granting of a Market Authorisation in the EU
2018-06-29 nanoparticle suspension containing biosynthetic codon-optimized human ornithine transcarbamylase messenger MRT5201 - nanoparticle suspension containing biosynthetic codon-optimized human ornithine transcarbamylase messenger Translate Bio (USA - MA) ornithine transcarbamylase deficiency (OTC) mRNA/gene therapy. MRT5201 is a mRNA encoding the fully functional ornithine transcarbamylase. Translate Bio anticipates initiating a Phase 1/2 clinical trial of… Granting of the orphan status in the EU
2018-06-28 dexmedetomidine Dexdor® Orion Corporation (Finland)
  • sedation of adult intensive care unit (ICU) patients
Dexmedetomidine is a relatively selective alpha2-agonist which acts on the central nervous system to produce sedation. Positive opinion for the granting of a Market Authorisation in the EU
2018-06-28 tolvaptan Jinarc® Otsuka Pharmaceutical (Japan) autosomal dominant polycystic kidney disease  vasopressin receptor 2 antagonist. Tolvaptan is a selective, competitive vasopressin receptor 2 antagonist. Tolvaptan acts by blocking receptors in the kidneys… Granting of a Market Authorisation in the EU
2018-06-28 lesinurad and allopurinol Duzallo® Ironwood Pharmaceuticals (USA - MA) Gruenenthal (Germany)
  • hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone
uric acid reabsorption inhibitor/purine analog/selective uric acid re-absorption inhibitor (SURI). Lesinurad is a selective uric acid reabsorption inhibitor (SURI) that inhibits… Positive opinion for the granting of a Market Authorisation in the EU