Keyword: European Medicines Agency (EMA)

News

US Approves AstraZeneca’s Zurampic Gout Drug

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

Baxalta Gets EU Nod for Hemophilia Treatment

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

EU Commissions Backs New GSK Asthma Drug

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

Sanofi to Streamline Global Organization From 2016

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

EU Approves Sales of Sanofi’s New Diabetes Drug

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

European Price Wars Seen Shaping up Over Hepatitis C Drugs

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

Discovering the Future of Pharma

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

GDUFA’s Impact on the API Industry – an Update

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...