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The Year of the Unpartnered Blockbuster? High Profile Applications Raise Big Questions

This article was originally published in RPM Report

Executive Summary

Several of the highest profile new drug applications pending or expected to be submitted as 2010 begins involve potential blockbuster market opportunities. They also lack Big Pharma partners. Is Big Pharma really that picky? Or are the applications out of step with the regulatory and commercial climate? Either way, intense investor interest will keep FDA in the spotlight.

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Weighing the Risks: Vivus View of Regulatory Risks in Qnexa Reprise

A good-news press release from Vivus on the resubmission and acceptance of its application to FDA for the weight-loss drug Qnexa contains an unusually long and descriptive list of the risks involved in the application. This more than boiler-plate “forward-looking” statement adds new interest to the sport of footnote-analysis.

The Qnexa Vote: Beyond the Bean Counting

FDA's Endocrinologic & Metabolic Drugs voted 10-6 against approval of Vivus' weight loss drug Qnexa (phentermine/topiramate) at this time. But committee members were almost unanimous in agreeing that it was a very close call, and their comments captured the nuance of the many issues FDA must resolve in the context of reviewing weight loss drugs in general and this application in particular. Below is our transcript of the discussion by each panelist about the reasons for their vote.

Dendreon vs. CMS:Controversy Is Bigger Than One Product

It appeared as though the controversy over the level of efficacy and benefit from the prostate cancer immunotherapy Provenge ended when the drug was approved by FDA at the end of April. The FDA approval may have just been the halfway point in the product's route through government agencies to the commercial market. Now Medicare is questioning whether the government should pay for the new therapy. The CMS decision is just as important to the biopharmaceutical industry as it is to Dendreon.

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