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EMA

Showing 15 posts of 400 posts found.

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Doctor questions FDA’s diet drug approvals

August 23, 2013
Research and Development, Sales and Marketing BMJ, Belviq, EMA, FDA, Vivus, diet pills, obesity

News
Votrient image

GSK seeks licence extensions

August 8, 2013
Sales and Marketing Cervarix, EMA, GSK, Votrient

GlaxoSmithKline is seeking to extend the licences of two of its brands, Cervarix and Votrient, in a bid to extend …

News
EMA image

EMA: no cancer risk from GLP-1s

July 29, 2013
Research and Development, Sales and Marketing Cancer, EMA, GLP-1s

One of the European Medicines Agency’s key advisory groups has decided that concerns over an increased cancer risk with some …

News
EFPIA image

Secret EFPIA memo on data transparency leaked

July 22, 2013
Medical Communications, Research and Development, Sales and Marketing ABPI, EFPIA, EMA, PhRMA, transparency

A memo from the European pharma lobby group EFPIA has revealed that the industry is trying to ‘mobilise’ patient groups …

News

Court overturns orphan refusal

July 10, 2013
Sales and Marketing EMA, laboratoires ctrs, orphacol

A European Commission decision last year to refuse marketing authorisation for an orphan drug has been overturned by a major …

News
prof_brendan_buckley

ICON appoints chief medical officer

July 4, 2013
Manufacturing and Production, Research and Development, Sales and Marketing EMA, ICON, buckley

Clinical research organisation ICON has confirmed the appointment of Professor Brendan Buckley as chief medical officer. Buckley will be ICON’s …

Appointment
EMA image

EMA ponders biosimilar guideline

May 14, 2013
Research and Development, Sales and Marketing EMA, biosimilars

The European Medicines Agency is thinking about changes to its guidance on similar biological medicines and has published a draft …

News
EMA image

Court rules against EMA disclosure

May 2, 2013
Medical Communications, Research and Development, Sales and Marketing AbbVie, EMA, Roche, transparency

The European Medicines Agency (EMA) has been ordered in an interim ruling by the General Court of the European Union …

News
GSK image

GSK submits UMEC monotherapy

April 29, 2013
Sales and Marketing COPD, EMA, GSK, UMEC

GlaxoSmithKline has put its investigational once-daily medicine umeclidinium bromide (UMEC) up for scrutiny by European regulators for patients with chronic …

News

EMA launches ‘black triangle’ post-marketing scheme

April 28, 2013
Sales and Marketing EMA, Post-marketing surveillance, black triangle, pharmacovigilance

The European Medicines Agency has unveiled its new ‘black triangle’ post-marketing surveillance system, and the list of drugs that will …

News

New head at European Medicines Agency

April 8, 2013
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA

The European Medicines Agency has appointed Agneta Brandt as the new head of Infrastructure Services. Brandt joins the Agency from …

Appointment
EMA image

EU orphan designations rise

February 19, 2013
Research and Development, Sales and Marketing COMP, EMA, Orphan, hta

The number of orphan drug designations in the EU is set to rise to record levels this year, according to …

News
EMA offices, London

EMA starts contraceptive safety review

January 30, 2013
Manufacturing and Production, Sales and Marketing EMA, PRAC, VTE, contraception

Europe’s health regulator is to examine the safety of newer forms of contraceptive pills following concerns over potential health risks …

News
Tysabri image

Biogen and Elan file for Tysabri first line use in MS

January 18, 2013
Sales and Marketing Biogen IDEC, EMA, Elan, FDA, MS, Tsyabri, gilenya

Biogen Idec and Elan have applied to the FDA and EMA to expand Tysabri’s use in patients with relapsing forms …

News
EMA offices, London

EMA issues draft guidance on shared facility risks

January 17, 2013
Manufacturing and Production EMA, manufacturing

The European Medicines Agency has issued draft guidance to help drug manufacturers avoid cross-contamination of products made in shared facilities. …

News
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