QDIS Blog

Dendreon hit a major snag last week when the FDA declined to approve the drug without further data. THese are somewhat misleadingly called “approvable letters. For more on approvable letters see What Do Approvable Letters Mean? from Mark over at Ee on FDA.

Dendreon will delay Provenge, cuts jobs:

This led to a major drop in stock price and Denreon announcing it will lay off 400 workers mainly those geared towards commercialization of Provenge. If things go well, the company said it could launch the drug as soon as 2008 but it could be as late as 2010.

What is surprising in this case is the the advisory committee unanimously voted (17-0 on safety and 13-4 on efficiency) to approve the drug and it is rare that the agency would then not approve it. Looks like the FDA may be getting more cautious or has access to information that wasn’t know to the committee.

For another look at this see Eye on FDA: Dendreon Gets Complete Response Letter

Technorati Tags: Dendreon, Provenge

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Contract Pharma has an article on Albany Molecular purchasing manufacturing facilities in India.

AMRI Acquires Manufacturing Facilities in India - Contract Pharma

What is surprising to me is how little they paid for it; $11 million for these assets which earned $5 million in revenue last year!

It is interesting that some contract manufacturers are buying facilities in India to get access to cheap labor and that Indian companies are buying European and North American companies for name recognition and established clients.

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