European Medicines Agency

Close collaboration with new host country as of day one key for successful move LONDON, 09-Nov-2017 — /EuropaWire/ — With less than two weeks to go before EU Member States select a new host city for the European Medicines Agency (EMA) … Read the full press release →

LONDON, 10-Oct-2017 — /EuropaWire/ — The European Medicines Agency (EMA) and the European Commission have updated the annex to the European Commission guideline on excipients in the labelling and package leaflet of medicinal products for human use. Excipients refer to everything in a medicine other than the active substance. While most excipients are considered inactive, some can have … Read the full press release →

European Medicines Agency and healthcare payer organisations held joint meeting on 19 September LONDON, 29-Sep-2017 — /EuropaWire/ — The European Medicines Agency (EMA) and European Union (EU) healthcare payers met for the first time on 19 September 2017 at EMA’s offices … Read the full press release →

Investigational RNAi Therapeutic Patisiran Meets Primary and All Secondary Endpoints, with Highly Significant Reduction In Neuropathy Progression and Improvement in Quality of Life at 18 Months Relative to Placebo Alnylam Intends to File New Drug Application (NDA) in Late 2017 … Read the full press release →

New study combining Esbriet (pirfenidone) and nintedanib showing similar safety profile for the combination treatment to that expected for each treatment alone A second, retrospective, post-hoc, analysis suggests that treatment with Esbriet may be associated with a reduction of multiple … Read the full press release →

BRUSSELS, 03-Aug-2017 — /EuropaWire/ — The application procedure to host the two UK-based EU agencies, the European Medicines Agency (EMA) and the European Banking Authority (EBA), came to a close at midnight last night, 31 July 2017. The European Commission will … Read the full press release →

The European Medicines Agency (EMA) is currently looking for a new location in connection with the UK’s withdrawal from the EU. Sweden has now submitted its official offer to host the EMA. STOCKHOLM, 03-Aug-2017 — /EuropaWire/ — The offer guarantees … Read the full press release →

Positive phase III results for Roche’s emicizumab in haemophilia A published in The New England Journal of Medicine HAVEN 1 showed emicizumab reduced bleed rate by 87% compared with on-demand bypassing agents All 12 secondary endpoints in HAVEN 1 were … Read the full press release →

European Commission approves Sandoz Rixathon® to treat blood cancers and immunological diseases. Approval expected to broaden patient access to biologics and enable budget-constrained healthcare systems to reallocate resources to other healthcare priorities. Sandoz now has four biosimilars approved in Europe … Read the full press release →

Subgroup analysis shows >80% reduction in the risk of disability progression with Cladribine Tablets vs placebo DARMSTADT, 02-May-2017 — /EuropaWire/ — Merck, a leading science and technology company, announced the presentation of new analyses of efficacy and safety data for … Read the full press release →

LONDON, 03-Apr-2017 — /EuropaWire/ — As a science-driven organisation, the European Medicines Agency (EMA) has developed a framework to formalise, structure and further develop interactions with the academic community in the context of the European medicines regulatory network. The framework … Read the full press release →

EMA workshop will discuss role of patients, consumers and healthcare professionals LONDON, 07-Mar-2017 — /EuropaWire/ — How has the concept of personalised medicine evolved globally and in the European Union and what are its regulatory challenges and opportunities? These are some … Read the full press release →