1 2 3 4 143
Number of results: 2851
Date Compound Product name Company Disease Action mechanism Type of Information
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
2018-01-25 TK cell therapy Zalmoxis® - TK cell therapy MolMed (Italy)
  • adjunctive treatment in hematopoietic stem cell transplantation (HSCT) for patients affected by high risk leukaemia
cell therapy. Zalmoxis® is a cell therapy product, based on the use of genetically engineered donor T cells with a… Product launch
2018-01-25 ertugliflozin monotherapy, ertugliflozin and Januvia® (sitagliptin), fixed-dose combination of ertugliflozin and metformin. Steglatro®, Steglujan, Segluromet™ Merck&Co (USA - NJ) Pfizer (USA - NY) type 2 diabetes SGLT2 inhibitor. Positive opinion for the granting of a Market Authorisation in the EU
2018-01-22 dupilumab Dupixent® Sanofi (France) Regeneron Pharmaceuticals (USA - NY) moderate-to-severe atopic dermatitis monoclonal antibody. Dupilumab, a fully-human monoclonal antibody, is directed against the IL-4 receptor alpha subunit, which blocks signaling from both… Granting of a Market Authorisation in Japan
2018-01-19 benralizumab Fasenra® AstraZeneca (UK)
  • add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype
  • add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting Beta-agonists
monoclonal antibody. Benralizumab is a monoclonal antibody directed at the alpha subunit of the interleukin-5 receptor (IL-5Ralpha) that depletes eosinophils, a… Granting of a Market Authorisation in Japan
2018-01-19 adeno-associated viral 5 (AAV5) gene therapy - Adeno-associated viral vector serotype 5 encoding a microRNA targeted to human huntingtin gene AMT-130 - Uniqure (The Netherlands) Sanfilippo B syndrome (rare autosomal recessive lysosomal storage disease, which manifests in young children) gene therapy. AMT-130 consists of an AAV5 vector carrying an engineered micro-RNA specifically designed to silence the huntingtin gene. The… Granting of the orphan status in the EU
2018-01-17 apremilast Otezla® Celgene (USA - NJ) pediatric patients with ulcerative colitis phosphodiesterase 4 inhibitor. Otezla® is an oral, small-molecule, selective inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results… Granting of the orphan status in the US
2018-01-15 bevacizumab-awwb - biosimilar version of Avastin® Mvasi™ - ABP 215 Amgen (USA - CA) Allergan (Ireland)
  • non-squamous non-small cell lung cancer (NSCLC)
  • metastatic colorectal cancer (mCRC)
  • glioblastoma
  • metastatic renal cell carcinoma
  • persistent, recurrent, or metastatic carcinoma of the cervix
monoclonal antibody/biosimilar. ABP 215 is being developed as a biosimilar to bevacizumab, which is approved in specific combinations in the U.S.,… Granting of a Market Authorisation in the US
2018-01-09 lenvatinib mesylate and pembrolizumab Lenvima® and Keytruda® Eisai (Japan) Merck&Co (USA - NJ) renal cell carcinoma tyrosine kinase inhibitor/monoclonal antibody/immune checkpoint inhibitor. Lenvima®, discovered and developed by Eisai, is an oral molecular targeted agent that selectively… Granting of the Breakthrough Therapy status
2018-01-08 letermovir Prevymis® AiCuris (Germany) Merck & Co (USA)
  • treatment of cytomegalovirus (CMV) disease in patients with impaired cell mediated immunity deemed at risk
  • prevention of HCMV (human cytomegalovirus) disease
Granting of a Market Authorisation in the EU