Tag Archive > FDA

Dendreon to seek Provenge approval in November – Reuters

» 24 September 2009 » In Prostate Cancer, Provenge, Vaccines » Comments Off

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:

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Video of FDA hearing on Provenge March 29th

» 07 June 2007 » In Clinical trials, Provenge, Vaccines » Comments Off

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.

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Prostate cancer patients, families, rally in Washington D.C.

» 05 June 2007 » In Prostate Cancer, Provenge » Comments Off

Prosstate cancer patients, families and advocates rally in Washington DC June 4th to demand Approve Provenge Now

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

Thomas Farrington of Prostate Health Education Network addressed the group.

Jan Manarite of Raise a Voice

Raise a Voice organizer Jan Manarite introduced speakers including Tom Farrington and Dr. Mark Moyad.

Podium with Jan, Thomas Farrington, malecare petition poster

The petition campaign was organized by malecare.com.

Visit Joel Nowak’s advancedprostatecancer.net blog,
Provenge Advocacy Hits the News

Help My Dad Live! sign carried at Prostate Cancer rally

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.

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Prostate Cancer Doctor Receives Death Threat Over Provenge

» 03 June 2007 » In Clinical trials, Prostate Cancer, Provenge, Vaccines » 4 Comments

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.

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Provenge and the attack on FDA

» 20 May 2007 » In Clinical trials, Prostate Cancer, Provenge, Vaccines » Comments Off

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.

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FDA Alert for ‘True Man’ and ‘Energy Max’

» 18 May 2007 » In Complementary + Alt Med » Comments Off

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.

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Raise A Voice Writes to FDA Advisory Committee

» 07 May 2007 » In Awareness Events, Dendreon, Prostate Cancer, Provenge, Vaccines » Comments Off

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).

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Second oncologist asks FDA to wait on Provenge

» 26 April 2007 » In Clinical trials, Prostate Cancer, Provenge, Vaccines » 10 Comments

Maha Hussain M.D.Dr. Maha Hussain (left) is calling for an open access program for Dendreon’s Provenge prostate cancer vaccine (Sipuleucel-T) pending completion of an ongoing, 500 man clinical trial, She made this suggestion March 29 during the FDA Advisory Committee hearing after voting “No” on the vaccine’s efficacy. She followed up with a letter to the FDA reiterating her “No” position and again calling for an open access program.

Dr. Hussain is the second oncologist among 4 members of the panel who voted “No” to the efficacy of the drug who has followed up with a letter to the FDA.

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A call for open access to Dendreon’s prostate cancer vaccine

» 26 April 2007 » In Clinical trials, Prostate Cancer, Provenge, Vaccines » 2 Comments

Dr. Maha Hussain, an oncologist who was one of 4 out of 17 members of the FDA Advisory Committee to vote against accepting against the company’s claim to efficacy for Provenge (Sipuleucel-T) prostate cancer vaccine, is calling for an expanded access program to empower patients who want and need it to receive the drug while an ongoing 500 man clinical trial of Provenge is completed.

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Scher to FDA about Provenge hearing

» 17 April 2007 » In Clinical trials, Prostate Cancer, Provenge, Vaccines » 6 Comments

This is the text of Howard Scher M.D.’s letter to FDA about the March 29th advisory committee hearing on Dendreon’s vaccine Sipuleucel-T (Provenge):

I am writing to express concerns about the recent review of Sipuleucel-T at the FDA Advisory Meeting on March 29, 2007. These concerns are: a recommendation for approval based on data that fall short of the regulatory requirements; an inadequate statistical construct to determine definitive benefit; incomplete data on product safety; and what appear to be different criteria for approval by two Advisory Committees to the Agency.

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