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LONDON – Taking the EMA's advice on trial design is both voluntary and costly, but a new analysis shows that doing so vastly increases the likelihood of getting marketing approval.

PARIS – Refinement of the EMA's rules for advanced therapy medicinal products (ATMPs), which came into effect in 2009, is ongoing, but, so far at least, there is little evidence to suggest that the legislation has been an enabler for companies developing cell therapies or gene therapies.

DUBLIN – The ongoing delay in appointing a new executive director to the (IMI), Europe’s €3.3 billion (US$2.1 billion) public-private partnership on drug research, shows no immediate signs of ending, while its interim director, EC official Irene Norstedt, has defended the initiative against a major media onslaught.

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