Drug Approvals
FDA Breakthrough Designations 2013: The List So Far
FDA’s fourth and newest expedited approval pathway for medicines has begun to bear fruit. Established in 2012 within the FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designations have so far totaled 25 as of the end of July. Following is a list of approved breakthroughs announced thus far in order of their announcement dates ...Read more
Drug Approvals
True Innovation Lies in Quality — Not Quantity — of Approvals, says FDA
We’re already embroiled in the annual speculation game about whether FDA approvals this year will keep pace with last year’s near-record of 39 new molecular entities (NMEs) brought to market. But this focus on the quantity of new drug approvals is misleading, according to FDA analysts ...Read more
Special Feature
Pharm Exec’s 2013 Emerging Pharma Leaders
Meet Pharm Exec’s 15 Emerging Pharma Leaders of 2013. These trendsetters represent the future of an industry that knows it must change. The question is how, and to what? ...Read more
Retrospective Studies
Assessing the Value of Retrospective Studies: Real-World Evidence, Real-World Applications
The value of retrospective studies cannot be overstated, writes Sarah Ray. They provide clear advantages at different points of the product life-cycle and, during drug development, may help clinical teams propose adaptations or even a companion diagnostic tests to identify the patient populations most likely to benefit from a company’s experimental treatment ...Read more
New eBook
The Best of the Successful Product Manager's Handbook Volume III
In the third volume of this four-volume set from the pages of Pharmaceutical Executive, you'll arm yourself with information and expert accounts to fortify your marketing plans against both the unexpected and the inevitable ...Read more
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