Keyword: European Medicines Agency (EMA)
News
28.03.2014
- GlaxoSmithKline (GSK), the UK's largest pharmaceutical company, has provisionally withdrawn its marketing authorization application to the European Medicines Agency (EMA) for the...
News
20.03.2014
- The European Medicines Agency, EMA, has said it will try out a new process of staggered drug approvals in a bid to accelerate access to new medicines. The decision to pilot so...
News
22.10.2013
- Europe's medicines regulator has come out fighting for greater transparency for clinical trials, arguing that its controversial policy to end data secrecy will be "a boon to drug...
Plant Construction & Process Technology
10.09.2013
- The Perfect Storm - More and more chemical and pharmaceutical companies are recognizing the need to make their processes more environmentally sustainable, a trend that is right at...
Plant Construction & Process Technology
06.08.2013
- One-Time Fee - On Oct. 1, 2012, the U. S. Food and Drug Administration (FDA) implemented the long-discussed Generic Drug User Fee Act (GDUFA) , thereby authorizing the agency to...
News
29.07.2013
- Swiss drugmaker Novartis won an important endorsement of its new inhaled medicine for chronic lung disease on Friday when European regulators recommended approval of Ultibro...
News
25.06.2013
- The European Medicines Agency's (EMA) decision to release detailed data on drugs once a medicine is approved could discourage critical investment in crisis-hit Europe, Sanofi's...
News
30.04.2013
- Europe's medicines regulator has been stopped from releasing clinical trial data about drugs made by AbbVie and Intermune, following a court ruling favouring the two U.S. companies...
