European Medicines Agency

Fresh design and improved features to provide better user experience LONDON, 25-Sep-2018 — /EuropaWire/ — The European Medicines Agency (EMA) will launch a new version of its corporate website (www.ema.europa.eu) on 27 September 2018. The new website will have an improved … Read the full press release →

Approval based on COMBI-AD study demonstrating greater than 50% reduction in risk of disease recurrence or death in stage III melanoma patients   More than 50% of stage III melanoma patients are likely to recur to stage IV during their lifetime … Read the full press release →

The EC approval is based on the first global CAR-T registration trials, which included patients from eight European countries and demonstrated durable responses and a consistent safety profile in r/r pediatric B-cell ALL and r/rDLBCL Novartis is the only company with an approved … Read the full press release →

EMA launches new submission portal today LONDON, 20-Jun-2018 — /EuropaWire/ — The European Medicines Agency (EMA) has launched a new secure online portal for orphan designation applications. The portal, named ‘Iris’, provides a single space where applicants can submit and manage the information and … Read the full press release →

Publication of updated Q+As and practical guidance LONDON, 20-Jun-2018 — /EuropaWire/ — The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). Updates to the questions-and-answers … Read the full press release →

Trial meets the primary endpoint of durable complete response Majority of patients who had a complete response had no evidence of any remaining detectable cancer cells Phase III clinical trial results served as basis for recent US FDA regulatory submission … Read the full press release →

Workshop with regulators from EU, Japan and US open for registration LONDON, 28-May-2018 — /EuropaWire/ — The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States’ Food and Drug Administration (FDA) are co-organising a workshop to discuss the development … Read the full press release →

Kymriah demonstrated an overall response rate of 50%, with median duration of response not yet reached at the time of data cut-off, indicating sustainability of response[1] Kymriah is the only CAR-T therapy FDA-approved for two distinct indications – in non-Hodgkin … Read the full press release →

WACKER TAKES OVER SYNCO BIO PARTNERS OF AMSTERDAM CAPACITY OF ACQUIRED FERMENTATION PLANT FOR PHARMACEUTICAL ACTIVES TOTALS SOME 2,000 LITERS – WACKER BIOTECH’S OVERALL CAPACITY DOUBLES AS A RESULT SYNCO’S EXPERTISE IN MANUFACTURING LIVE MICROBIAL PRODUCTS AND IN FILLING FINISHED … Read the full press release →

Sandoz is seeking approval of biosimilar infliximab for use in all indications of its reference medicine across gastroenterology, rheumatology and dermatology Positive opinion is based on comprehensive clinical and non-clinical data that is expected to confirm that Sandoz biosimilar infliximab … Read the full press release →

Medicine to be voluntarily withdrawn from the market by the company LONDON, 06-Mar-2018 — /EuropaWire/ — The European Medicines Agency (EMA) has started an urgent review of the multiple sclerosis medicine Zinbryta (daclizumab) following 7 cases of serious inflammatory brain disorders … Read the full press release →

Marketing Authorization will enable patient access to ADYNOVI throughout Europe ZUG, 16-Jan-2018 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced today that the European Commission (EC) has granted Marketing Authorization for ADYNOVI … Read the full press release →

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 →