Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

The Provenge Precedent

This article was originally published in RPM Report

Executive Summary

Dendreon's therapeutic cancer vaccine Provenge is the first of its kind to make it to an FDA advisory committee. The committee gave the novel agent a thumbs up. But FDA may disagree and turn away the prostate cancer vaccine until there is more conclusive data of its safety and effectiveness. How much does Dendreon stand to lose?

You may also be interested in...



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.

Dendreon and InterMune: Do They Mean Anything for the Regulatory Climate at FDA?

Provenge and pirfenidone were two of the most closely watched pending applications at FDA. The agency's decision on the two therapies may offer some insight into the current regulatory climate.

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

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.

Related Content

Topics

Related Companies

Related Deals

UsernamePublicRestriction

Register

ID1132356

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel