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...
30.06.2014
- The European Medicine Agency (EMA) has recommended approval of Abasria, Eli Lilly's biosimilar version of Sanofi's insulin glargine sold as Lantus. This means that the French...
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...
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- GlaxoSmithKline (GSK), the UK's largest pharmaceutical company, has provisionally withdrawn its marketing authorization application to the European Medicines Agency (EMA) for the...
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...
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...
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...
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...
