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Brexit move creates EMA risk: report pharmatimes
September 29, 2017
The Brexit-inspired need to move the London HQ of the European Medicines Agency will throw up two major risks when it comes to patients and the approval of new medicines, according to a new report.
EMA relocation will cause drug approval delays even in best case scenario, agency says pharmafile
September 28, 2017
As a direct result of the UK’s referendum vote to leave the EU last year, the headquarters of the EMA, currently located in Canary Wharf, London, will be forced to relocate to another EU member state.
EMA accepts Pfizer’s bosulif Type II Variation application for Ph+ CML pharmaceyfical-technology
September 01, 2017
The European Medicines Agency (EMA) has approved for review a Type II Variation application for the use of Pfizer’s bosulif (bosutinib) to treat patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML).
FDA, EMA and EC sign new confidentiality commitment pharmatimes
August 25, 2017
The US Food and Drug Administration can now share non-public and commercially confidential information, including trade secrets relating to medicines inspections, with EU regulators after the parties signed a new commitment.
Bluebird Bio Expects Europe as first market for its gene therapies fiercebiotech
August 08, 2017
Bluebird Bio seeks to bring its gene therapies to European Market before the U.S., taking the advantages of a favorable regulatory pathway, which is appealing to the pharmaceutical companies.
EMA reveals 'business continuity plan' for Brexit, cuts resources from non-essential areas pharmafile
August 03, 2017
The uncertainty caused by Brexit has been and continues to be far-reaching, and perhaps most impactful for business, organisations and their practices.
EMA unveils business continuity plan ahead of UK exit from EU firstwordpharma
August 02, 2017
The European Medicines Agency on Tuesday revealed its business continuity plan ahead of its relocation from the UK as part of the country's decision to leave the EU.
Deadline looms for EMA host city bids pharmaphorum
August 01, 2017
Today marks the deadline for bids to host the European Medicines Agency after Brexit, as various EU states aim to win a prize that could attract investment from pharma.
Eisai seeks marketing authorisation for lenvatinib from EMA pharmaceutical-technology
July 31, 2017
Eisai has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for first-line use of lenvatinib in patients with unresectable hepatocellular carcinoma (uHCC).
EMA's CHMP Issues Positive Opinion for Avelumab for the Treatment of Metastatic Merkel Cell Carcinom en-cphi.cn
July 24, 2017
Merck and Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of avelumab* (BAVENCIO®)...

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