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 ...

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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 ...

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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 ...

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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, ...

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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 ...

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Evaluation of ethical analyses in seven reports from the European Network for Health Technology Assessment

16 July 2019 - Ethics has been considered among the core domains of health technology assessment, but there are still ...

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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 ...

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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, ...

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Report calls for European funding reform for gene therapies

8 July 2019 - New payment models, dedicated investment, and better health technology assessment are among a raft of changes ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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