European Medicines Agency
UCB plots new Vimpat submissions after positive monotherapy results
October 8, 2015Research 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. …
EMA launches project to boost early patient access to drugs
September 8, 2015Research 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 …
EMA backs GSK’s malaria vaccine for use in Africa
July 24, 2015Manufacturing 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 …
EMA in push for more paediatric drug trials
July 24, 2015Medical 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 …
Big-name generics among new CHMP recommendations
April 27, 2015Sales 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 …
EMA begins pilot for electronic drug applications
March 14, 2012Medical Communications EMA, European Medicines Agency, eCTD
The European Medicines Agency has launched a pilot scheme that allows pharma firms to submit new drug applications electronically. The …
EMA road map to prioritise pharmacovigilance
January 28, 2011Research and Development, Sales and Marketing EMA, European Medicines Agency, pharmacovigilance
The European Medicines Agency is to prioritise issues such as pharmacovigilance over the next five years, while also looking closely …
EMA to widen public access to documents
December 1, 2010Research and Development, Sales and Marketing EMA, European Medicines Agency, European Ombudsman, patient information, transparency
The European Medicines Agency has agreed to give greater access to documents on medicines for human and veterinary use, after …
Pharma engages HTA bodies in early-stage drug discussions
October 27, 2010Research and Development, Sales and Marketing Andrew Witty, AstraZeneca, EMA, European Medicines Agency, GlaxoSmithKline, Johnson & Johnson, health technology assessment, hta
Three pharma companies are taking part in a new pilot to harmonise European standards in health technology assessment (HTA). AstraZeneca, …
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