European Medicines Agency

16-8-2013 — /EuropaWire/ — The European Medicines Agency has published a reflection paper on general issues for consideration regarding the parenteral administration of coated nanomedicines today. The reflection paper describes general issues to consider during the development of nanomedicines that have a coating, including: the effect … Read the full press release →

30-7-2013 — /EuropaWire/ — The European Medicines Agency (EMA) has published the ‘First annual report onEudraVigilance for the European Parliament, the Council and the Commission’, which covers the period from 1 January to 31 December 2012. It is the third time the … Read the full press release →

12-7-2013 — /europawire.eu/ — The European Medicines Agency is organising training sessions on the use of the eSubmission Gateway and web client to submit periodic safety update reports (PSURs) subject to the single-assessment procedure. These training sessions are intended for all applicants submitting … Read the full press release →

Recognition by the US Food and Drug Administration (FDA) that RLX030 has the potential to address a serious unmet medical need If approved, RLX030 has the potential to be the first treatment breakthrough for Acute Heart Failure patients in 20 … Read the full press release →

2-7-2013 — /europawire.eu/ — New Phase III data presented at the American Diabetes Association 73rd Scientific Sessions® (ADA) showed linagliptin improved blood glucose control as monotherapy and in combination with metformin, in Asian people from China, Malaysia and the Philippines with … Read the full press release →

Ingelheim, Germany and Indianapolis, US, 1-7-2013 — /europawire.eu/ — Boehringer Ingelheim and Eli Lilly and Company today announced results from a new analysis of Phase III data demonstrating that treatment with the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin is not associated with … Read the full press release →

26-6-2013 — /europawire.eu/ — The European Medicines Agency has released a draft policy on the publication and access to clinical-trial data for a three-month public consultation. Stakeholders have until 30 September 2013 to send their comments on the draft policy to … Read the full press release →

27-5-2013 — /europawire.eu/ — The European Ombudsman, P. Nikiforos Diamandouros, dealt with more than 30 000 complaints and opened almost 3 500 investigations into alleged maladministration in the EU administration during his ten years in office. In 2012 alone, he received 2 442 complaints (2510 in … Read the full press release →

23-4-2013 — /europawire.eu/ — These sorts of new techniques potentially offer exciting possibilities to patients for the treatment of a range of difficult or previously untreatable conditions. Like all treatments, these techniques also come with benefits and risks. Specific rules were introduced … Read the full press release →

Key deliverable of Falsified Medicines Directive achieved 22-4-2013 — /europawire.eu/ — The European Medicines Agency has upgraded its EudraGMP database so that it now contains information on good distribution practice (GDP) in addition to good manufacturing practice (GMP). The new database, now called EudraGMDP, is a … Read the full press release →

Commission publishes European test results on horse DNA and Phenylbutazone: no food safety issues but tougher penalties to apply in the future to fraudulent labelling Brussels, 18-4-2013 — /europawire.eu/ — Launched last month, the coordinated EU-wide testing for horsemeat DNA and phenylbutazone1 requested, … Read the full press release →

4-4-2013 — /europawire.eu/ — The European Medicines Agency welcomes Agneta Brandt as the new Head of Infrastructure Services. Agneta Brandt joins the Agency from a position as Managing Director of Arken, a large conference centre in Sweden. She has over 20 … Read the full press release →

Roche’s Pegasys receives EU approval for the treatment of chronic hepatitis C in children five years of age and older Basel, 4-4-2013 — /europawire.eu/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency (EMA) has expanded the … Read the full press release →

In more than 70 percent of patients, disability scores improved or remained stable over three years —  More than 80 percent of patients treated with LEMTRADA did not receive a third course of treatment in the first year of the … Read the full press release →

Genzyme Planning to Request Re-examination of New Active Substance Designation Paris, France, 27-3-2013 — /europawire.eu/ — Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines … Read the full press release →

Brussels, 7-3-2013 — /europawire.eu/ — Questions and answers: New ‘black symbol’ for medicinal products What is the black symbol? The black symbol is an inverted equilateral black triangle to be included in product information for certain categories of medicinal products. The symbol … Read the full press release →

Hexyon/Hexacima will be the only fully liquid, ready-to-use, 6-in-1 pediatric vaccine in Europe Lyon, France, 4-3-2013 — /europawire.eu/ — Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the Committee for Medicinal Products for Human Use (CHMP) … Read the full press release →

31-1-2013 — /europawire.eu/ — The French medicines agency announced today its plan to suspend the marketing authorisation for Diane 35 (cyproterone acetate 2 mg, ethinylestradiol 35 micrograms) and its generics for acne treatment in France within three monthscorr. These medicines are … Read the full press release →

Review to determine whether changes to authorisation are necessary 28-1-2013 — /europawire.eu/ — The European Medicines Agency has been asked by France to review third- and fourth-generation combined oral contraceptives to determine whether there is a need to restrict the use … Read the full press release →

24-1-2013 — /europawire.eu/ — The European Medicines Agency has been formally notified by Novartis Europharm Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Ruvise (imatinib mesilate), 100 and 400 mg film-coated tablets. It was … Read the full press release →