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 →