European Medicines Agency

Acromegaly is an endocrine disorder caused by elevated growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels[1] Signifor LAR, a next-generation somatostatin analog, provides a new option for patients with acromegaly with inadequately controlled disease[2] Signifor LAR FDA approval is … Read the full press release →

Leicester, UK, 15-12-2014 — /EuropaWire/ — A team from the University of Leicester and Leicester’s Hospitals has played a vital role in identifying a new treatment for reducing the risk of death or emergency hospital admission among patients with serious … Read the full press release →

Acromegaly is a rare pituitary disorder, which requires normalization of hormonal levels to help prevent the serious consequences of the disease[1],[2],[3],[4] Approval based on two large phase III trials showing superior efficacy of new formulation of Signifor over current SSAs … Read the full press release →

The new RebiSmart® injection device offers many new updates including wireless transmission of injection times and doses MSdialog™software is designed to more effectively engage people with MS and their health care providers with treatment adherence information and health related outcome reports … Read the full press release →

LONDON, 13-11-2014 — /EuropaWire/ — GSK today announced the submission to the European Medicines Agency (EMA) of a variation to the Marketing Authorisation for eltrombopag (Revolade™), seeking an additional indication for the treatment of adult patients with severe aplastic anaemia … Read the full press release →

Developers encouraged to request accelerated procedure for scientific advice LONDON, 30-10-2014 — /EuropaWire/ — The European Medicines Agency (EMA) has given scientific advice to GSK on its development plan for an Ebola vaccine. This is the first time in the … Read the full press release →

EMA to allow use of non-EEA authorised comparator in clinical studies; new guidance applicable as of today LONDON, 30-10-2014 — /EuropaWire/ — The European Medicines Agency (EMA) has published its revised overarching guideline on biosimilars. The main change brought by this … Read the full press release →

PARIS, 29-10-2014 — /EuropaWire/ — ExPRESS 2015 is the name of the exciting new programme for the upcoming annual EURORDIS Summer School. ExPRESS, which stands for Expert Patients and Researchers EURORDIS Summer School, will gather for the first time both … Read the full press release →

• HOTLINE: New results from RE-LY® compare the effect of warfarin and Pradaxa® on kidney function in patients requiring anticoagulation • HOTLINE: GLORIA™-AF Registry Program benchmarks patient characteristics and antithrombotic use for stroke prevention in AF worldwide For Non-US/Non-UK/Non-Canadian Media … Read the full press release →

Only First-Line Oral Treatment for Adult Gaucher Disease Type 1 Paris, 22-8-2014 — /EuropaWire/ — Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has approved Cerdelga™ (eliglustat) capsules, the only … Read the full press release →

Meta-analysis of three late-stage trials in people with type 2 diabetes shows decreases in risk of low blood sugar events of up to 31% at night-time compared with Lantus® All studies in the phase 3 “EDITION” clinical trial program, including a … Read the full press release →

LONDON, 4-3-2014 — /EuropaWire/ — The European Medicines Agency reminds applicants and marketing-authorisation holders that adjusted fees will be coming into effect on Tuesday 1 April 2014. Every year, the Agency adjusts its fees on 1 April, in line with the European … Read the full press release →

Company is pleased to host second international conference dedicated to the research of rare and orphan diseases Novartis is engaging in public dialogue to help raise greater awareness of rare diseases and support for patients Company celebrates more than 50 … Read the full press release →