NEJM spotlights Provenge study

Shares of Dendreon (NASDAQ: DNDN) soared into the stratosphere in the lead-up to Provenge's approval--and then promptly started tumbling fast as all sorts of questions arose about supply issues, cost and efficacy. But the company is likely to benefit enormously from the publication of its biggest study of the innovative prostate cancer vaccine in the prestigious New England Journal of Medicine, which carries biblical weight with providers....

Sarcoma Foundation calls for radical change in FDA review process

Mark Thornton, a former medical officer at the FDA and current president of the Sarcoma Foundation of America, uses the recent Provenge approval to illustrate why the FDA needs to reverse its position on the cancer drug Mepact. Back in 2007 the FDA decided that both Provenge and Mepact should go back to the clinic for a new study. Dendreon was able to afford that because it was pursuing a mega-blockbuster approval for prostate cancer. But the developers of Mepact were essentially...

Dendreon CEO cashes in $28.8M of shares on Provenge OK

Dendreon (NASDAQ: DNDN) CEO Mitchell Gold had a busy day last Thursday, when the FDA capped the developer's 15-year quest with an approval of the revolutionary new prostate cancer vaccine Provenge. Just hours after the approval sent the company's stock up sharply higher, following months of steadily rising prices, Gold sold off more than $28 million in newly optioned shares. That afternoon he exercised his options on 270,625 shares for anywhere from $4.41 to $9.77 and sold them for $51.01. The...

Cancer vaccine developers bask in Provenge limelight

Now that Dendreon has completed its victory lap following Thursday's high-profile approval for Provenge, the spotlight has inevitably shifted to the other cancer vaccines in the pipeline. "It sets the stage, or at least facilitates, the approval of other cancer vaccines," Michael Becker, chief executive of MD Becker Partners, tells Dow Jones about the Provenge action. Becker compares the Provenge approval to Rituxan's arrival in 1997, which heralded the potential of monoclonal...

The Twitter newsroom is packed with biopharma writers

After I had just finished wrapping up my daily missive from FierceBiotech yesterday, a tweet caught my eye at the corner of the screen. @adamfeuerstein from TheStreet had just picked up the first word that Dendreon's Provenge had been approved.  Inside of a few minutes, the editorial team at FierceBiotech had nailed down a news link to the report and added it to the top of our online news round-up for the day. You had it in your e-mail queue while the first reports were still spitting off...

Dendreon: Provenge to cost $93K for full course of treatment

One of the most pressing questions analysts and patients have had about Provenge is how much Dendreon would charge for its newly approved prostate cancer drug. Following this afternoon's conference call, we now have an answer. Each infusion of Provenge will cost $31,000, bringing the full cost of treatment for three infusions to $93,000. As the company put it, the drug will cost about $23,000 per month of life extension, based on the Phase III study that found the drug extended...

FDA approves Dendreon’s breakthrough cancer vaccine Provenge

The FDA has approved Dendreon's Provenge, a breakthrough cancer vaccine that promises to extend the lives of prostate cancer victims by several months. Widely seen as a likely blockbuster with a cost of around $75,000 per patient, the approval comes after the Seattle-based Dendreon (NASDAQ: DNDN) braved a major setback at the FDA in 2007 and forged ahead with a confirmatory Phase III study of the therapy. Betting that the agency would go ahead with an approval, Dendreon has invested...

Biotech watchers on high alert for Provenge decision

Just about every biotech analyst on the planet knows that the FDA is facing a May 1 deadline for a decision on Dendreon's Provenge. As that's a Saturday, we're likely to hear about a final decision on one of this year's biggest new therapies by Friday--and the biotech world is on high alert. Over at TheStreet, Adam Feuerstein ran an informal poll of those in-the-know and came up with an odds-on favorite of full approval. Waiting for word this week, he writes, "will be like...

How much is too much to pay for Provenge?

With Dendreon's hotly anticipated prostate cancer drug Provenge on the doorstep of FDA approval, the company now must answer a tough question: How much can they charge for a drug that extends survival just a few months? In a study of 512 men, results showed that subjects taking the drug survived a median time of four months longer than those not receiving the therapy. Dendreon has been gearing up for production of the drug--the FDA will make a decision by May 1--and analysts have been...