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EMA validates Gilead Sciences’ marketing application for BIC/FTC/TAF combination pharmaceutical-technology
July 17, 2017
US biopharmaceutical company Gilead Sciences’ marketing authorisation application (MAA) for a fixed-dose drug combination to treat HIV-1 infection in adults has been fully validated and is currently under evaluation by the European Medicines Agency (EMA).
EMA and FDA aim to slash Gaucher disease R&D costs pharmaphorum
July 06, 2017
US and European regulators want to promote the development of drugs for paediatric Gaucher disease, moves which could also apply to other rare diseases in children.
EMA and FDA propose new approach for Gaucher disease drug development pharmaceutical-technology
July 06, 2017
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have proposed new approaches to the development of medicine to treat Gaucher disease.
QS Pharma Gains EMA Approval for Commercial Manufacture contractpharma
June 28, 2017
Boothwyn, PA facility to manufacture certain medicinal products for commercial use in Europe
EMA approves Janssen’s Prezista continuous manufacturing line europeanpharmaceuticalreview
June 28, 2017
The EMA has approved Janssen’s continuous manufacturing (CM) with real-time release testing for the production of Prezista (darunavir)…
Novartis achieves regulatory milestone for AMG 334 in migraine prevention with EMA filing acceptance cphi-online
June 23, 2017
AMG 334 (erenumab) is the first anti-CGRP monoclonal antibody developed for migraine prevention to receive EMA regulatory filing acceptance.
Novartis files migraine drug with EMA pharmaphorum
June 22, 2017
Novartis has filed its migraine drug erenumab with the EMA, putting it in pole position among a group of pharma companies racing to develop a new class of drugs to treat the debilitating condition.
EMA’s Brexit relocation decision date announced pharmaphorum
June 22, 2017
The European Medicines Agency has given an update on its preparations for Brexit, ahead of the October meeting that will decide its new location.
EMA issues guidance document in preparation for Brexit europeanpharmaceuticalreview
June 21, 2017
The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies prepare for the United Kingdom’s withdrawal from the European Union.
EMA action plan supports SMEs as drivers of innovation europeanpharmaceuticalreview
June 21, 2017
The European Medicines Agency (EMA) has published an action plan that aims to foster innovation and support small and medium-sized enterprises (SMEs) in the development of novel human and veterinary medicines.

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