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Posts Tagged ‘FDA approval’

MIAMI HERALD: A test to detect prostate cancer in the blood before it spreads is being investigated at the University of Miami School of Medicine. READ MORE>

Researchers at the school are creating a test to trap and identify cancer cells circulating in the blood before they reach the liver, brain or lymph nodes.

A sample of the patient’s blood is passed through a new microfilter they are developing, trapping cancer cells, which are larger than healthy blood cells.

The test is three to five years from FDA approval.

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WALL STREET JOURNAL: Dendreon Corp expects to file for marketing approval for advanced prostate cancer immunotherapy treatment Provenge in mid-November and hopes to get final FDA approval in the middle of next year. READ MORE>

NEW PROSTATE CANCER INFOLINK: It is worth remembering that Provenge is not a “drug” in any normal sense of the term. READ MORE>

Provenge is strictly a form of individual cell-based immunotherapy in which cells from the patient’s own body are extracted, modified, and then re-infused back into the patient.

Every single dose of Provenge therefore has to be individually created.

PROSTABLOG NZ: The pressure on NZ’s drug approval organisation, Pharmac, to fast-track Provenge to Kiwi patients is shaping to be another Herceptin debate.

In that case, it seems only a very loud and effective campaign by sufferers succeeded in getting the expensive breast cancer treatment past Pharmac’s drug subsidisation process.

If Provenge has to be individually manufactured for each patient, you can bet the doses will cost thousands of dollars.

Pharmac may be spared the dilemma beyond next year, since it seems the manufacturer will not be able to fulfill the demand in the US, let alone other countries.

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PROSTABLOG NZ: When global mainstream media reported the recent (partial) success of Dendreon drug company getting FDA approval for its new immunotherapy prostate cancer drug, Provenge, they didn’t mention how makers of a now-discredited rival drug may have delayed its path to chemist shops.

An “alternative” market investors’ website called Market Rap.com has just published a story by a former Wall Street Journal journalist that purports to reveal a murky background to what might be called – if it’s all, even partly, true – one of America’s biggest drug scandals.

It involves the US prostate Cancer Foundation (no relation to NZ’s) and its ubiquitous chairman, Michael Milken, who featured recently on the Larry King Live special about prostate cancer.

If you’ve got lots of time, READ MORE>

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ADVANCEWEB.COM: Degarelix, a new drug for treatment of prostate cancer, has gained FDA approval.  A gonadotropin releasing hormone (GnRH) receptor inhibitor, the drug is intended to treat patients with advanced cancer, and slows the growth and progression of the cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer, according to FDA officials. READ MORE>

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