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European Medicines Agency

Showing 15 posts of 19 posts found.

Novartis’ Mayzent granted license by the European Medicines Agency

January 21, 2020
Manufacturing and Production CNS, European Medicines Agency, NHS, NICE, Novartis

The European Medicines Agency (EMA) has granted a licence for the use of Mayzent (siponimod) in the treatment of certain …

News
credit_-_daniel_leal-olivas-afp

CHMP rejects AB Science’s ALS therapy in Europe

April 23, 2018
Sales and Marketing AB Sciences, EMA, European Medicines Agency, ab science, als, masitinib, pharma

AB Science has revealed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a …

News
untitled

European Medicines Agency: Staying consistent in a turbulent time

June 12, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, European Medicines Agency, brexit

With Brexit looming, the future of the EMA headquarters in London has been cast in doubt. Pharmafocus spoke to Marie-Agnes …

Feature

GSK’s gene therapy for rare condition in children gets EMA backing

April 4, 2016
Research and Development, Sales and Marketing ADA-SCID, European Medicines Agency, GlaxoSmithKline, Orphan Therapy, Rare Treatment, drug trial, gene therapy

UK drug major GlaxoSmithKline (LSE: GSK) has won marketing recommendation from European regulators for its first gene therapy to treat …

News
christa_wirthumer-hoche

European Medicines Agency elects Christa Wirthumer-Hoche as new chair of management board

March 21, 2016
Medical Communications, Research and Development Christa Wirthumer-Hoche, EMA, European Medicines Agency, chair, chairperson, wirthumer-hoche

Christa Wirthumer-Hoche has been elected chair of the management board of the European Medicine’s Agency. She has served as vice …

Appointment
Gilenya

EMA adds warning label to Novartis’ MS treatment Gilenya

December 22, 2015
Manufacturing and Production EMA, European Medicines Agency, FDA, Novartis, PML, basal cell carcinoma, fingolimod, gilenya

Drug safety regulators in Europe have said they will add warnings to the label and prescribing information of Gilenya (fingolimod), …

News
sir_kent_woods

EMA management board chair stands down

December 21, 2015
Manufacturing and Production, Sales and Marketing EMA, European Medicines Agency, Sir Kent Woods

Sir Kent Woods will step down as chair of the board at the EMA from the end of December 2015. …

Appointment
Janssen image

Janssen submits Stelara for EU approval for Crohn’s

December 9, 2015
Sales and Marketing Crohn’s disease, EMA, European Medicines Agency, Janssen, Stelara, crohn's disease, ustekinumab

Janssen today announced that it has submitted an application to the European Medicines Agency, seeking approval of Stelara in Crohn’s …

News
Europe flag

EMA launches scheme to prioritise medicines access for patients

October 27, 2015
Manufacturing and Production EMA, European Medicines Agency, medicines access

The EMA has launched a public consultation on a scheme which aims to enable access to more medicines.The PRIME scheme …

News
cosentyx_logo

Novartis’ Cosentyx gets European approval for two conditions

October 23, 2015
Medical Communications, Sales and Marketing Cosentyx, European Medicines Agency, Novartis, psoriatic arthritis

The scientific committee of the European Medicines Agency (EMA) has recommended the approval of Novartis’ Cosentyx (secukinumab) for treatment of ankylosing …

News

UCB plots new Vimpat submissions after positive monotherapy results

October 8, 2015
Research and Development EMA, European Medicines Agency, UCB, carbamazepine, epilepsy, lacosamide, phase III, vimpat

A Phase III non-inferiority study comparing UCB’s Vimpat with carbamazepine suggests the two drugs can be used as monotherapy treatments.  …

News
Europe flag

EMA launches project to boost early patient access to drugs

September 8, 2015
Research and Development EMA, European Medicines Agency, MAPPs, adaptive pathways, drug development, market access

The EMA is launching an adaptive pathway project to bring new medicinal products to market in Europe.  The ADAPT SMART …

News
Vaccination

EMA backs GSK’s malaria vaccine for use in Africa

July 24, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CHMP, Committee for Medicinal Products for Human USE, EMA, European Medicines Agency, GSK, WHO, malaria, world health organization

GSK has taken a significant step forward toward being the first company to bring a malaria vaccine to market, after …

News
EMA

EMA in push for more paediatric drug trials

July 24, 2015
Medical Communications, Research and Development EMA, European Medicines Agency, clinical trials, drug development, paediatrics

The European Medicines Agency has relaxed some of its rules around the development of drugs in children, in order to …

News
EM HQ

Big-name generics among new CHMP recommendations

April 27, 2015
Sales and Marketing CHMP, EMA, European Medicines Agency, Lyrica, pregabalin

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended 11 new medicines for approval, among them several …

News

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