BioSante Pharmaceuticals, Inc. has announced the receipt of Orphan Drug designation for GVAX CML Vaccine in the treatment of chronic myeloid leukemia (CML) from the FDA’s Office of Orphan Products Development. Orphan drug designation, as granted by the U.S. Orphan Drug Act, is for a product to treat a rare disease that affects almost 200,000 Americans. Orphan drug designation qualifies the sponsor of the product for tax credits and seven years of marketing exclusivity.

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According to researchers at Britain’s Institute of Cancer Research (ICR), a combination of three genetic abnormalities has a dramatic impact on how long prostate cancer patients are likely to live. They added that prostate cancer patients should be tested for specific genetic factors before doctors decide how aggressively to treat their tumors.

OncoGenex Pharmaceuticals Inc said that the US Food & Drug Administration (FDA) has given a “fast track designation” for the company’s metastatic prostate cancer drug candidate. The OGX-O11 drug, also known as custirsen sodium, when combined with first-line docetaxel (chemotherapy) treatment, has been given the designation, which is only given to drugs “that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease.”

A study conducted by Brigham & Women’s Hospital-Dana-Farber Cancer Institute indicated that prostate cancer patients with certain heart conditions who received hormone therapy either before or with radiation therapy were at higher risk of death than equivalent patients who did not have hormone therapy. The study reflected that the risk of death nearly doubled for men with coronary artery disease-induced congestive heart failure or heart attack when they received hormone therapy in addition to radiation therapy.

The US FDA has approved the Abbreviated New Drug Application (ANDA) for generic Casodex Bicalutamide tablets to Sun Pharmaceutical Industries’ subsidiary. These bicalutamide tablets with strength of 50 milligram are therapeutically equivalent to Casodex tablets from AstraZeneca and are used in combination therapy with a lutenizing harmone-releasing harmone (LHRH) analog for the treatment of stage D2 metastatic carcinoma of the prostate. The annual sales of the Casodex tablets are about $314 million in the US.

To relieve the patients who have undergone prostate cancer surgery from the pain of recovery, doctors at Weill Cornell Medical College have developed an approach which is patient-friendly in the sense that it eliminates the use of a penile urinary catheter. The novel technique which is used along with robotic prostatectomy (the surgical removal of the prostate) does away with the discomfort that is associated with the standard catheter. In this approach, urine is redirected from the bladder through a narrow tube that goes out through a small needle puncture below the gut.

The value of the prostate-specific antigen (PSA) test as a diagnostic tool for prostate cancer has declined following changes in medical practice, according to a new study. Study author Dr. Douglas S. Scherr said that the PSA test is still very predictive in men with an abnormal digital rectal examination, while for men with a normal digital rectal examination, the test’s predictive accuracy has declined. For the latter category of men, doctors are opting for biopsies and are using improved biopsy techniques.