European Medicines Agency

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 →

The EGALITY study met its primary endpoint demonstrating equivalent efficacy of Sandoz biosimilar etanercept candidate to the originator product at week 12 As a first-of-its kind, the confirmatory clinical safety and efficacy study compares originator etanercept to a biosimilar candidate … Read the full press release →

OCREVUS is the first investigational medicine seeking marketing authorisation for both relapsing and primary progressive multiple sclerosis (MS) FDA grants Priority Review Designation for OCREVUS Biologics License Application (BLA) BASEL, 29-Jun-2016 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced … Read the full press release →

Sandoz advances biosimilar portfolio with sixth major biosimilar file acceptance in less than one year Sandoz is seeking approval for all indications included in the reference product’s label Sandoz’ submission includes data from multiple clinical trials with over 800 patients … Read the full press release →

LONDON, 02-May-2016 — /EuropaWire/ — AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder. CAZ … Read the full press release →

• A single 5g dose of idarucizumab immediately reversed the anticoagulant effect of dabigatran in all patients evaluated • Results based on analyses of high-risk patients from RE-VERSE AD™ study • Data presented at ACC 2016 Scientific Session and Expo … Read the full press release →

SUBJECT: REGULATORY LANDSCAPE FOR PHARMA MANUFACTURERS AMSTERDAM, 30-Mar-2016 — /EuropaWire/ — Christoph Krähenbühl, senior director, 3C Excellis, will be a featured speaker at Systech International’s upcoming global conference in Amsterdam titled UNIQUITY Europe, 2016, focused on serialization, global brand protection … Read the full press release →

Offers Integrated Serialization Equipment Solutions to the Global Pharma Industry BRUSSELS, 15-Mar-2016 — /EuropaWire/ — Systech International, a global leader in brand protection technologies, announces the addition of Inno4Life, an internationally recognized Original Equipment Manufacturer in Life Science equipment solutions, to its Unisolve™ partner … Read the full press release →

Requirements for industry now available on submission of clinical data for publication LONDON, 04-Mar-2016 — /EuropaWire/ — The European Medicines Agency (EMA) has published detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of … Read the full press release →

LONDON, 10-12-2015 — /EuropaWire/ — AstraZeneca today announced plans to test a digital support service for women undergoing treatment for recurrent platinum-sensitive high-grade ovarian cancer in clinical trials of cediranib plus olaparib. Voluntis has developed the service in close clinical … Read the full press release →

Executive Director appointed for five-year term LONDON, 20-11-2015 — /EuropaWire/ — Professor Guido Rasi has taken office as Executive Director of the European Medicines Agency (EMA) today. Professor Rasi was nominated as Executive Director for a five-year mandate by the … Read the full press release →

EMA veterinary committee sets objectives to limit risks arising from use of antimicrobials in animals LONDON, 20-11-2015 — /EuropaWire/ — The European Medicines Agency has released for public consultation a new strategy on antimicrobials for 2016-2020 adopted by its Committee … Read the full press release →

Deadline to submit expressions of interest to represent civil society at PRAC andCAT to European Commission extended until 18 October LONDON, 1-10-2015 — /EuropaWire/ — The Health and Food Safety Directorate-General of the European Commission has extended the deadline for … Read the full press release →

ADAPT SMART PARIS, 30-9-2015 — /EuropaWire/ — EURORDIS is partnering in the recently launchedADAPT SMART* project, which will establish a platform that enables the coordination of Medicines Adaptive Pathways to Patients (MAPPs) activities. MAPPs can help to ensure access to … Read the full press release →

LONDON, 14-7-2015 — /EuropaWire/ — The European Medicines Agency (EMA) has started a review of HPV vaccines to further clarify aspects of their safety profile. These vaccines have been used in around 72 million people worldwide and their use is … Read the full press release →

EMA publishes workshop report on requirements for the authorisation of vaccines LONDON, 14-7-2015 — /EuropaWire/ — The European Medicines Agency (EMA) has published today the outcome of a workshop which explored how to ensure the availability of veterinary vaccines in … Read the full press release →

Promacta® (eltrombopag) significantly increased and sustained platelet counts in two studies, including the largest Phase III clinical trial in this patient population Characterized by a low platelet count[1], ITP can affect up to 5 in 100,000 children each year[2] and … Read the full press release →