Free Newsletter
FDA scolds Dendreon on Provenge marketing
Dendreon (NASDAQ: DNDN) is in hot water with the FDA's marketing watchdogs already. The company's sales materials for the brand-new prostate cancer vaccine Provenge don't pass muster, the agency says, because they exaggerate the novel treatment's benefits and soft-pedal its risks.
"These promotional materials are false or misleading because they omit and minimize the risks and overstate the efficacy of Provenge," the FDA says in a letter to the company, Reuters reports. The agency also tells Dendreon to stop using the offending materials immediately, and to also pull any other sales aids that make similar claims.
Granted, it's not easy to explain the subtleties of Dendreon's data on Provenge. The FDA appears to acknowledge that in its letter, saying that one piece lacked "sufficient contextual information" that would "convey the limitations" of Dendreon's main study of the drug.
- read the Reuters story
- get more from Dow Jones
Related Articles:
Provenge scrips hit 500 as payers agree to pay
NEJM analyzes data on Provenge
Private payers mull restrictions on Provenge
Dendreon: Provenge to cost $93K for full course
Paid Research Reports
- Trends in mHealth and Telemedicine
- The Global Aesthetic Dermatology Market Outlook
- Future Directions in Regenerative Medicine
- Pipeline Insight: Insulin Antidiabetics – Novel analogs show promise as alternative delivery methods prove less attractive
- Pipeline Insight: Non-insulin Antidiabetics - Rise of the weight-reducers: Once-weekly GLP-1 agonists and novel SGLT-2 inhibitor
- Forecast Insight: Antidiabetics - Diabetes market growth driven by epidemiological trends and rich pipeline


SHARE
WITH: