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RSS FeedPosted by Michael Wonder on 16 Oct 2019
First Algenex CrisBio-based vaccine submitted to European Medicines Agency
15 October 2019 - Potential approval would validate the use of Algenex’ CrisBio technology for the manufacture of recombinant subunit vaccines. ...
Posted by Michael Wonder on 08 Oct 2019
Vivus announces acceptance of Qsymia decentralised marketing authorisation application in Europe
7 October 2019 - Vivus announced today that European regulatory agencies in Sweden, Denmark, Finland, Iceland, Norway, and Poland have ...
Posted by Michael Wonder on 20 Sep 2019
Emmaus Life Sciences announces withdrawal of marketing authorisation application to European Medicines Agency
19 September 2019 - Emmaus Life Sciences today announced the withdrawal of its marketing authorisation application to the European Medicines ...
Posted by Michael Wonder on 19 Sep 2019
Novartis has submitted application to EMA for approval of Cosentyx in nr-axSpA, which would be the fourth indication
17 September 2019 - 52-week data from the PREVENT study, to support FDA submission, are expected later in the year. ...
Posted by Michael Wonder on 18 Sep 2019
Biofrontera files label extension for Ameluz in EU to include treatment of actinic keratosis on extremities and trunk/neck
17 September 2019 - Biofrontera has filed a label extension for Ameluz with the EMA on August 28, 2019 to include ...
Posted by Michael Wonder on 09 Sep 2019
Allergan and Molecular Partners announce acceptance of U.S. FDA biologics license application and validation of EMA marketing authorisation for abicipar pegol in patients with neovascular (wet) age-related macular degeneration
9 September 2019 - Filing includes data from two Phase 3 trials which evaluated the safety and efficacy of abicipar quarterly ...
Posted by Michael Wonder on 22 Aug 2019
Mundipharma announces the licence extension submission for Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin) to the European Medicines Agency
22 August 2019 - The CREDENCE renal outcomes study, which was stopped early due to positive efficacy findings, served as the ...
Posted by Michael Wonder on 16 Aug 2019
European Medicines Agency validates marketing application for filgotinib for the treatment of rheumatoid arthritis
15 August 2019 - Gilead Sciences and Galapagos today announced that the marketing authorisation application for filgotinib, an investigational, oral, ...
Posted by Michael Wonder on 08 Aug 2019
Molecular Partners’ strategic partner Allergan announced today that EMA has validated the marketing authorisation application for abicipar
6 August 2019 - Molecular Partners today announced that the EMA has validated the marketing authorisation application of its strategic partner ...
Posted by Michael Wonder on 29 Jul 2019
ViiV Healthcare submits regulatory application to European Medicines Agency for investigational cabotegravir to be used in combination with rilpivirine as the first monthly, injectable treatment for HIV
29 July 2019 - The marketing application is based on phase III ATLAS and FLAIR pivotal trials in which the once-monthly, ...
Posted by Michael Wonder on 25 Jul 2019
Astellas announces acceptance by the EMA of a variation application for regulatory review for use of Xtandi (enzalutamide) in metastatic hormone-sensitive prostate cancer
24 July 2019 - Astellas Pharma announced the acceptance by the EMA of a Type II variation application for regulatory review ...
Posted by Michael Wonder on 20 Jul 2019
Blueprint Medicines announces European Medicines Agency validation of marketing authorisation application for avapritinib for the treatment of PDGFRα D842V mutant GIST and fourth-line GIST
18 July 2019 - Blueprint Medicines Corporation today announced that the EMA has validated the company's marketing authorisation application for avapritinib ...
Posted by Michael Wonder on 20 Jul 2019
EU starts evaluating Samsung Bioepis’ sales application for Avastin biosimilar
19 July 2019 - Samsung Bioepis said that the EMA has started evaluating its application to market SB8, an Avastin ...
Posted by Michael Wonder on 20 Jul 2019
Janssen seeks EMA approval for novel subcutaneous formulation of Darzalex (daratumumab)
19 July 2019 - Data supporting the application demonstrated that the investigational subcutaneous formulation improved quality of life, reduced administration time, ...
Posted by Michael Wonder on 10 Jul 2019
FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma
10 July 2019 - The U.S. FDA has accepted for review the biologics license application for isatuximab for the treatment ...