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EMA accepts marketing authorization applications for Mylan and Biocon’s proposed biosimilars biospectrumasia
December 04, 2017
European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Applications for proposed biosimilar trastuzumab and proposed biosimilar pegfilgrastim
Amsterdam beats out Milan to host EMA fiercebiotech
November 22, 2017
Amsterdam will be the post-Brexit home of the European Medicines Agency, a decision made via drawing lots after the vote between the final two contenders came down to a tie.
EMA to Relocate to Amsterdam, the Netherlands americanpharmaceuticacreview
November 22, 2017
The European Medicines Agency (EMA) will relocate to Amsterdam in the Netherlands. This decision was taken today by the EU 27 Member States in the margins of the General Affairs Council.
EMA to change relocation to Amsterdam in the Netherlands europeanpharmaceuticalreview
November 21, 2017
The EMA will relocate to Amsterdam in the Netherlands. The Agency now has just over 16 months to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest.
EMA Grants Orphan Drug Designation to Debio 1347 americanpharmaceuticacreview
November 15, 2017
Debiopharm International announced the European Medicines Agency (EMA) granted Orphan Drug Designation to Debio 1347 for treatment of Biliary Tract Cancer affecting around 77,000 people in the European Union (EU).
EMA Grants Alnylam Accelerated Assessment of Patisiran americanpharmaceuticacreview
November 14, 2017
Accelerated assessment potentially provides a reduced review timeline from 210 to 150 days once the MAA is filed and validated.
EMA grants marketing authorisation for Prevymis against cytomegalovirus europeanpharmaceuticalreview
November 13, 2017
The EMA has recommended granting a marketing authorisation Prevymis, an antiviral medicine that prevents CMV reactivation and disease…
Mylan seeks EMA approval for two biosimilars expressbpd
November 08, 2017
Mylan has serious concerns about Teva’s ability to integrate and efficiently run a combined company, and deliver meaningful shareholder value, he said, adding “there is simply no track record for investors to find”. (Reuters)
CHMP backs one generic and six label extensions pharmatimes
October 17, 2017
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended just one generic medicine for approval at its October meeting.
EMA accepts marketing application for Imfinzi to treat NSCLC patients pharmaceufical-technology
October 11, 2017
MedImmune is the global biologics research and development division of AstraZeneca.

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