The stimulus bill provides an unprecedented $1.1 billion for comparative effectiveness research-and does so with none of the key provisions biopharma companies hope to see as the US federal government takes a more active role in the field. The good news: this is only the first round, and there is reason to believe the field is evolving as most pharma companies would want. But this isn't the time for manufacturers to let their guard down.
By Michael McCaughan
The first round of the legislative debate over health care reform in the US did not go pharma’s way.
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While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
