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Products

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Number of results: 2616
Date Compound Product name Company Disease Action mechanism Type of Information
2017-01-18 bezlotoxumab Zinplava® Merck&Co (USA - NJ) Clostridium difficile infection recurrence monoclonal antibody. Bezlotoxumab is a selective, fully-human, monoclonal antibody designed to neutralize C. difficile toxin B, a toxin that can damage… Granting of a Market Authorisation in the EU
2017-01-03 test best
2016-12-29 solithromycin solithromycin Cempra (USA - NC)

community acquired bacterial pneumonia (CABP)

antibiotic/macrolide. Solithromycin is a next-generation oral and intravenous fluoroketolide now in Phase 3 clinical development for the treatment of moderate… Refusal of a Market Authorisation in the US
2016-12-27 pegylated recombinant factor VIII Adynovate®/Adynovi® (EU) - BAX 855 Baxalta (USA - IL)

hemophilia A

blood coagulation factor/protein. Adynovate®/BAX 855 is based on Advate®, a full-length FVIII molecule. Through a collaboration with Nektar Therapeutics, BAX 855… Granting of a Market Authorisation in the US
2016-12-23 NGR-hTNF NGR-hTNF MolMed (Italy)

mesothelioma

protein. NGR-hTNF is a vascular targeting agent and a first-in-class compound in the class of peptide/cytokine complexes able to selectively… Submission of a Market Application in the EU
2016-12-22 silmitasertib CX-4945 - silmitasertib Senhwa Biosciences (Taiwan)

cholangiocarcinoma

kinase inhibitor. CX-4945 is a novel small molecule drug that inhibits protein kinase CK2, which plays an important role in… Granting of the orphan status in the US
2016-12-21 CCP-08 Vernalis (UK) Tris Pharma (USA - NJ)

cough cold

Acceptation for review of a NDA
2016-12-21 [177]Lutetium-DOTA[0]-Tyr[3]-Octreotate Lutathera® Advanced Accelerator Applications (France)

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.… Refusal of a Market Authorisation in the US
2016-12-20 ocrelizumab Ocrevus™ Genentech, a member of Roche Group (USA - CA - Switzerland)

primary progressive multiple sclerosis (PPMS)

relapsing multiple sclerosis (RMS)

monoclonal antibody. Ocrelizumab is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells. CD20-positive B cells are a… Acceptation for review of a NDA
2016-12-19 rucaparib Rubraca® Clovis Oncology UK - Clovis Oncology (USA)

ovarian cancer

enzyme inhibitor/PARP inhibitor. Rucaparib is an orally-available, small molecule PARP 1 (poly ADP-ribose polymerase) and PARP2 inhibitor being developed for the… Granting of a Market Authorisation in the US
2016-12-19 lumacaftor and ivacaftor Orkambi® Vertex Pharmaceuticals (USA - MA)

cystic fibrosis

CFTR potentiator/cystic fibrosis transmembrane regulator (CFTR) protein modulator. Ivacaftor (Kalydeco®) is a CFTR (CF transmembrane conductance regulator protein) potentiator. Lumacaftor is an investigational… Granting of a Market Authorisation in the EU
2016-12-19 sodium hyaluronate for peritendinous injection Orthovisc®-T Anika Therapeutics (USA – MA)

treatment of pain associated with chronic lateral epicondylosis

viscosupplement. Orthovisc®-T consists of a biocompatible, non-animal-derived and non-inflammatory formulation of hyaluronic acid similar to those found in the company's best-selling… Granting of a Market Authorisation in the EU
2016-12-16 CD19 specific CAR T cells also expressing an EGFRt JCAR017 Juno Therapeutics (USA - WA) relapsed/refractory (r/r) aggressive large B-cell non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma  or grade 3B follicular lymphoma cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy.  JCAR017 is a CD19-specific CAR T cell therapy. It uses a defined CD4:CD8 cell composition and… Granting of the Breakthrough Therapy status
2016-12-15 C1 esterase inhibitor Cinryze® Viropharma (USA), now Shire (UK - USA)

treatment and prevention of angioedema attacks in 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… Positive opinion for the granting of a Market Authorisation in the EU
2016-12-15 chlormethine Ledaga® Actelion (Switzerland)

cutaneous T-cell lymphoma

mycosis fungoides-type cutaneous T-cell lymphoma

alkylating agent. Chlormethine is a well-known anticancer medicine that belongs to the group ‘alkylating agents’. Alkylating agents kill cancer cells by… Positive opinion for the granting of a Market Authorisation in the EU
2016-12-15 alectinib hydrochloride Alecensa® Chugai (Japan) Roche (Switzerland) Genentech (USA - CA)

ALK fusion gene positive non-small cell lung cancer (NSCLC)

kinase inhibitor/tyrosine kinase inhibitor/ALK inhibitor. Alecensa® (alectinib hydrochloride) is an oral ALK inhibitor created by Chugai Kamakura Research Laboratories. It… Positive opinion for the granting of a Market Authorisation in the EU
2016-12-15 ustekinumab Stelara® Janssen-Cilag International, a J&J company (USA - NJ)

treatment of moderate to severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies

monoclonal antibody. Stelara® is a human interleukin (IL)-12 and IL-23 antagonist. IL-12 and IL-23 are naturally occurring proteins that are… Submission of a Market Application in the US
2016-12-15 biosimilar rituximab - biosimilar version of Mabthera®/Rituxan® Truxima® (CT-P10) Celltrion (Republic of Korea)

non-Hodgkin’s lymphoma

chronic lymphocytic leukaemia

rheumatoid arthritis

granulomatosis with polyangiitis and microscopic polyangiitis

biosimilar product/monoclonal antibody. Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of… Submission of a Market Application in the EU
2016-12-15 5-aminolevulinic acid Ameluz® Biofrontera Bioscience (Germany)

actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2) and of field cancerization

Positive opinion for the granting of a Market Authorisation in the EU
2016-12-15 pembrolizumab Keytruda® Merck&Co (USA - NJ)

patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test

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