Reuters and WAll Street Journal report today that Dendreon plans to seek US FDA approval for Provenge prostate cancer vaccine in November. Dendreon "expects regulators to act on the application by the middle of next year, the company said on Thursday."
To start from an updated report in the Wall Street Journal, which adds this information to Reuters' coverage of Dendreon 's share prices today. The points are excerpted and reordered: ...continue reading "Dendreon to seek Provenge approval in November – Reuters"
A link to a 5 hour video recording of the FDA Advisory Committee hearing held March 29 on sipuleucel-T (Provenge) for advanced, androgen independent prostate cancer. The video does not include the vote.
A full written transcript in .pdf including the voting is online at FDA, click here.
A crowd of about 70 people led by prostate cancer advocates marched and rallied in Washington, D.C. on June 4 to call on the FDA to Approve Provenge Now.
Thomas Farrington of Prostate Health Education Network addressed the group.
Raise a Voice organizer Jan Manarite introduced speakers including Tom Farrington and Dr. Mark Moyad.
The petition campaign was organized by malecare.com.
Visit Joel Nowak's advancedprostatecancer.net blog,
Provenge Advocacy Hits the News
Organizer Jan Manarite receives a hug
from her son, who carried the message
"Help My Dad Live"
On June 5, campaigners met with FDA director Andrew von Eschenbach.
View ABC-TV video here. See photos of the rally (by brad.wick) and video of Mark Moyad's speech.
Oncologist Dr. Howard I. Scher has received a death threat for opposing immediate FDA approval of Dendreon's Provenge therapeutic vaccine for prostate cancer. Another oncologist who opposes approval of Provenge without completion of an ongoing clinical trial, Dr. Maha Hussain, has received unspecified threats.
...continue reading "Prostate Cancer Doctor Receives Death Threat Over Provenge"
FoxNews ("Fair and Balanced") aired Killer Bureaucracy: Why the FDA is Keeping Lifesaving Drugs from Cancer Patients May 19, 2007. Paul Gigot interviewed Dr. Scott Gottlieb. Scott Gottlieb MD, a stock analyst appointed to a top FDA job by President Bush in 2005, returned to Wall Street where he promotes Dendreon's Provenge in his Forbes/Gottlieb Medical Technology Investor newsletter.
The Food and Drug Administration (FDA) is advising consumers not to purchase or use "True Man" or "Energy Max" products promoted and sold as dietary supplements throughout the United States. Both products -- touted as sexual enhancement products and as treatments for erectile dysfunction (ED) -- contain potentially harmful, undeclared ingredients.The products contain substances called analogs that have similar structures to active ingredients in approved prescription drugs.
The undeclared analog ingredients in True Man and Energy Max may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
...continue reading "FDA Alert for ‘True Man’ and ‘Energy Max’"
Raise a Voice, an advocacy group for advanced prostate cancer patients, which is calling for patient access to drugs that have passed through Phase I trials, has written a thank you letter to the FDA Advisory Committee on Dendreon's sipuleucel-T (Provenge).
...continue reading "Raise A Voice Writes to FDA Advisory Committee"