Open Medicine EU

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Joint letters with like-minded organisations are never easy to write, even among friends. Each organisation wants to add its own nuance.Different organisations may have different rules for sign-off on final drafts, and amendments can ping-pong from one to the other. I’ve been there. Sometimes, however, an issue is so important and clear that a joint… » read more

Posted by Jim Murray

Intermune have withdrawn one part of their legal challenge to EMA’s disclosure of documents concerning the medicine Esbriet. This needs careful explaining. The cases started when Intermune took legal action to stop disclosure by the EMA of documents relating to the medicine. They also applied for and received an interim order prohibiting disclosure until the… » read more

Posted by Jim Murray

Abbvie’s withdrawal of the case against the EMA was not entirely unilateral – it followed an agreement by the agency to accept a redacted version of the document they were going to publish in January 2013 and which was the subject of the legal challenge by Abbvie. Here is what the EMA said today: 03/04/2014… » read more

Posted by Jim Murray

What’s New?

I mentioned in passing in my last post that new medicines are not necessarily innovative. This can be seen in the 2010 Report of the French National Health Authority, the “Haute Autorité de santé”. The authority’s “Commission de la Transparence (évaluation des médicaments)” evaluates the efficacy of each medicine under two headings – the therapeutic… » read more

Posted by Jim Murray