Keyword: European Medicines Agency (EMA)
News
05.01.2016
- Swedish drugmaker AstraZeneca has gained approval from the US Food and Drug Administration (FDA) to market Zurampic, a treatment for gout, the debilitating form of inflammatory...
News
02.12.2015
- US biopharmaceutical company Baxalta has received European marketing approval for its hemophilia treatment Obizur. The drug is said to be the first recombinant porcine sequence...
News
25.09.2015
- Following the green light from health regulator European Medicines Agency, the European Commission is expected to decide on a final approval for GlaxoSmithKline’s (GSK) injectable...
News
16.07.2015
- French drugmaker Sanofi has announced plans to streamline its corporate structure with effect from January 2016. The company pointed to its heritage formed from a combination of...
News
29.04.2015
- The European Commission has granted marketing authorization in Europe for Sanofi's Toujeo, a next-generation basal insulin for the treatment of type 1 and type 2 diabetes mellitus...
News
20.01.2015
- Europe, where about 15 million people are believed to be infected with hepatitis C, could become the next battleground between US drugmakers Gilead Sciences and AbbVie in their...
Strategy & Management
30.09.2014
- Dramatic changes to the scientific and business environments have made it impossible for pharmaceutical companies to continue operating as they have in the past. A perceived...
Plant Construction & Process Technology
02.04.2014
- The Price of Doing Business - Following the 2012 implementation of the Generic Drug User Fee Act (GDUFA), an article in CHEManager Europe's July/August 2013 edition about GDUFA's...