European Medicines Agency

EMA invites feedback on its new draft guideline LONDON, 22-5-2015 — /EuropaWire/ — The European Medicines Agency (EMA) has released a draft guideline on quality, non-clinical and clinical aspects of gene therapies for a three-month public consultation. The document aims … Read the full press release →

EMA to host workshop on therapeutic use of bacteriophages LONDON, 22-5-2015 — /EuropaWire/ — The European Medicines Agency (EMA) will host a workshop on the use of bacteriophages to treat bacterial infections on 8 June 2015. The workshop will be … Read the full press release →

Companies encouraged to submit expressions of interest LONDON, 23-4-2015 — /EuropaWire/ — The deadline for submitting expressions of interest to participate in the information-sharing initiative for generics has been extended to give more time to companies to submit their applications. … Read the full press release →

Registration now open for a workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) on 28 May 2015 LONDON, 9-4-2015 — /EuropaWire/ — Enpr-EMA will hold its 7th annual workshop on 28 May 2015 at … Read the full press release →

Polycythemia vera (PV) is associated with overproduction of blood cells that can cause serious cardiovascular complications, such as stroke and heart attack[1] Clinical data show Jakavi® (ruxolitinib) significantly improved hematocrit levels and reduced spleen size, key measures of disease control[2] … Read the full press release →

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 →

London, UK, 23-10-2013 — /EuropaWire/ — ViiV Healthcare today announced the submission of a regulatory application in the United States for its investigational single-tablet regimen (STR) combining dolutegravir, abacavir and lamivudine for the treatment of people living with HIV-1. This New Drug … Read the full press release →

29-8-2013 — /EuropaWire/ — The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint question-and-answer document that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements of marketing-authorisation applications. Quality-by-design is a science- and … Read the full press release →