European Commission

Harriet Farmer's picture

First Gene Therapy Wins Backing in Europe – the Start of Things to Come


At €1 million a pop, expectations are high.  [[wysiwyg_imageupload:134:]]
But European regulators have given the initial thumbs up to Glybera (alipogene tiparvovec), the western world’s first gene therapy, paving the way for approval by the European Commission.

The treatment is for a rare type of pancreatic disorder in which patients have damaged copies of a gene which is essential for breaking down the fat content in foods.  Affecting one person in a million, the disease causes a build up of lipids in the blood stream, leading to abdominal pain and potentially fatal inflammation of the pancreas.

The decision marks an important advance for gene therapy, a field which has been hotly debated for many years due to shortcomings of previous investigational therapies.  Approval for Glybera, which was previously rejected on three occasions, will make it the first gene therapy to be available outside a clinical trial in Europe or the US.  China approved a gene therapy for head and neck cancer in 2004. Read full post »

Maria Patey's picture

Advertising + Prescription-only Drugs = Legal Minefield


Advertising prescription-only drugs in the EU is a
legal m[[wysiwyg_imageupload:99:]]inefield for drug makers, but for the moment, even in the age of ‘information anywhere’ the strict rules will remain.

This month, the European Commission has been in the headlines with an update relevant for all drug makers, communicators, advertisers and generally anybody responsible for the branding, promotion or distribution of prescription-only drugs across Europe. The update was announced after what appears to have been a review, prompted by proposals that there is increasing interest by patients to have a better understanding of the medicines they take. Read full post »