The Center for Drug Evaluation & Research approved one more new molecular entity in 2009 than it did in 2008. But dig a little deeper and there is promising evidence that the approval trend is on an upward trajectory. It is far too early to declare a turnaround, but at least there are signs that the FDAAA era is translating into more products making it to market.
By Michael McCaughan
The top-line doesn't always tell the whole story.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.
The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
