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EMA

Showing 15 posts of 400 posts found.

Guido Rasi

EMA sets out new five-year plan

December 9, 2015
Research and Development EMA, Guido Rasi

The European Medicines Agency’s (EMA) new executive director, Professor Guido Rasi, outlined his vision for his five-year mandate at the …

News
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
Gilead sign

Gilead awaits EU decision on hep C combo treatment

December 8, 2015
Research and Development EMA, Gilead, SOF/VEL, accelerated assessment, hepatitis C, sovaldi, velpatasvir

The EMA has granted Gilead Sciences an accelerated assessment for its application for a new Sovaldi combination treatment.The combination contains …

News
Logos

New regulatory submissions for AbbVie and Novo Nordisk

December 4, 2015
Medical Communications AbbVie, EMA, FDA, Novo Nordisk, Viekira Pak, insulin aspart

AbbVie and Novo Nordisk have submitted new drug applications to the US FDA and European Medicines Agency (EMA) respectively. The …

News
EMA HQ

EMA concludes HPV vaccines do not cause CRPS or POTS

November 9, 2015
Sales and Marketing EMA, HPV, HPV vaccine, PRAC, complex regional pain syndrome, drug safety, postural orthostatic tachycardia syndrome

The European Medicines Agency says there is no evidence from a detailed scientific review of reports linking complex regional pain …

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
gsk_hq

GSK’s Volibris gets pulmonary arterial hypertension approval in Europe

October 26, 2015
Research and Development, Sales and Marketing EMA, GSK

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion …

News
guido_rasi

EMA appoints Guido Rasi as executive director

October 9, 2015
Medical Communications, Sales and Marketing EMA, Guido Rasi

The European Medicines Agency’s (EMA’s) Management Board has nominated Professor Guido Rasi as the Executive Director of the Agency. The …

Appointment

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
scales

Standardising the pharma benefit-risk assessment process

September 1, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, FDA, benefit-risk analysis, pharmacoepidemiology, pharmacovigilance

Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view …

Feature

Abbvie and Roche report success in Phase II leukaemia trial

August 13, 2015
Research and Development AbbVie, Breakthrough Therapy Designation, CLL, EMA, FDA, Roche, chronic lymphocytic leukaemia, leukaemia, venetoclax

AbbVie plans to submit regulatory applications for its leukaemia drug venetoclax to the FDA and the EMA before the end …

News
Sanofi Regeneron

FDA and EMA approve heart drug Praluent

July 27, 2015
Sales and Marketing EMA, FDA, PCSK9, Regeneron, Sanofi, high cholesterol, praluent

The FDA and the EMA have both approved Sanofi and Regeneron’s new high cholesterol drug Praluent. Regulators on both sides …

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
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