Blog
RSS FeedPosted by Michael Wonder on 20 Jul 2019
EMA takes note of the European Ombudsman’s decision on pre-submission activities
19 July 2019 - EMA welcomes the European Ombudsman’s recognition of the value and need for scientific advice and her ...
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 19 Jul 2019
Patient registries may prove valuable in regulatory decisions, EMA study finds
18 July 2019 - Although patient registries can be heterogenous in their quality and design, a new study in Drug ...
Posted by Michael Wonder on 16 Jul 2019
Caladrius Biosciences receives advanced therapy medicinal product classification for CLBS12, its CD34+ cell therapy for critical limb ischaemia
15 July 2019 - Caladrius Biosciences announced today that the EMA has granted Advanced Therapy Medicinal Product classification to the Company’s ...
Posted by Michael Wonder on 15 Jul 2019
Report on the current status of the use of real‐world data and real‐world evidence in drug development and regulation
10 July 2019 - Radically expanding use of real‐world data and real‐world evidence holds the potential to substantially impact drug development, ...
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 ...
Posted by Michael Wonder on 08 Jul 2019
Guido Rasi elected chair of International Coalition of Medicines Regulatory Authorities
8 July 2019 - The International Coalition of Medicines Regulatory Authorities has elected EMA’s Executive Director Guido Rasi as its ...
Posted by Michael Wonder on 04 Jul 2019
EMA confirms WeWork as new sub-tenant for 30 Churchill Place; EMA also settles court case with Canary Wharf Group
4 July 2019 - The European Medicines Agency has reached an agreement with Canary Wharf Ltd over its premises at ...
Posted by Michael Wonder on 04 Jul 2019
Medicine shortages: EU network takes steps to improve reporting and communication
4 July 2019 - The European Union task force set up to address problems with medicines supply has published two ...
Posted by Michael Wonder on 04 Jul 2019
Ultomiris (ravulizumab) receives marketing authorisation from European Commission for adults with paroxysmal nocturnal hemoglobinuria
3 July 2019 - Ultomiris is the first approved, long-acting complement inhibitor for PNH, administered every other month, reducing the ...
Posted by Michael Wonder on 03 Jul 2019
Call for all sponsors to publish clinical trial results in EU database
3 July 2019 - The European Commission, the European Medicines Agency and the Heads of Medicines Agencies have co-signed a ...
Posted by Michael Wonder on 03 Jul 2019
ViiV Healthcare receives EU marketing authorisation for Dovato (dolutegravir/lamivudine), a new once-daily, single-pill, two-drug regimen for the treatment of HIV-1 infection
3 July 2019 - Authorisation based on GEMINI pivotal trials in which Dovato achieved non-inferior efficacy compared to a dolutegravir-based, three-drug ...
Posted by Michael Wonder on 02 Jul 2019
Libtayo (cemiplimab) approved for advanced cutaneous squamous cell carcinoma in the European Union
1 July 2019 - Libtayo is the only treatment approved in the EU for adult patients with metastatic or locally advanced ...