Keyword: EMA

News

Lundbeck's Alcohol Dependency Drug Gets EU Green Light

18.12.2012 - A novel drug to fight alcohol dependency was given a green light by European regulators on Friday, providing a boost to Danish drugmaker Lundbeck at a time when its top product...

News

EU Agency Rejects Sanofi, Isis Cholesterol Drug

18.12.2012 - European regulators recommended against approval of Sanofi and Isis Pharmaceutical's Kynamro drug for treatment of a rare genetic disorder that causes unusually high cholesterol...

News

Roche Offers Compromise in Flu Drug Row

22.11.2012 - Roche has offered an olive branch to scientific critics in a bid to end a bitter row over blockbuster flu drug Tamiflu that has led to calls for a boycott of the Swiss drugmaker's...

News

Roche May Face Fines for Lax Drug-Safety Reporting

23.10.2012 - Europe's drugs regulator has started an infringement procedure against Swiss pharmaceutical group Roche Holding to investigate its alleged failure to report fully tens of thousands...

News

EU Agency Lifts Lid on Drug Data Secrets

15.07.2012 - Europe's medicines regulator, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl...

Plant Construction & Process Technology

Non-compliance is on the Rise

19.10.2011 - Steady Increase - All who follow industry trends will have noticed an increase in regulatory actions related to non-compliance issues. We can see this in the increased issuance of...

News

European Medicines Agency Doesn't Expect Number of New Drug Filings to Grow in 2011

22.12.2010 - The European Medicines Agency expects roughly the same number of new drug applications in 2011 as in 2010, suggesting the pharmaceuticals industry has as yet done little to improve...

News

Biosimilar Antibodies: EMA Adopts Guideline

22.11.2010 - European regulators adopted a new guideline on so-called biosimilar antibody drugs on Friday, paving the way for cheaper copies of multi-billion-dollar medicines for cancer and...