Dilon Technologies has received CE Marking for its Dilon 6800 gamma camera. The high-resolution gamma camera enables molecular imaging of the breast and other small organs for early cancer detection. It performs breast-specific gamma imaging, a technique that images the metabolic activity of breast lesions through radiotracer uptake.

Abviva Inc. (formerly known as Genesis Bioventures) has been issued a pivotal patent by the United States Patent and Trademark Office for the core technology used in the company’s breast cancer diagnostic test. The Mammastatin Serum Assay (MSA) is a blood test used for the early detection of breast cancer through the identification and measurement of the amount of Mammastatin in women.

Urodynamix Technologies Ltd. has begun the evaluation of its second generation prototype near infrared spectroscopy (NIRS) DRE system. Digital rectal examination (DRE) is the most common screening test for prostate cancer and Urodynamix’s NIRS sensor measures blood flow in the prostate gland during the examination. The device improves physicians’ ability to detect prostate cancer as well as other prostate-related diseases.

Veridex LLC has received FDA clearance to market the CellSearch(TM) Circulating Tumor Cell (CTC) Kit as an aid to monitoring patients suffering from metastatic prostate cancer. The CellSearch System had already been cleared for metastatic breast and metastatic colorectal cancer and counts CTCs in a patient’s blood sample to predict progression-free and overall survival. The CellSearch CTC Kit was developed by Immunicon Corporation and is exclusively marketed by Veridex.

Orchid Chemicals & Pharmaceuticals Ltd. has received FDA approval for its Abbreviated New Drug Application (ANDA) for Granisetron Hydrochloride tablets in the 1-mg strength. Granisetron Hydrochloride tablets are a generic form of Roche’s Kytril drug, used to treat nausea induced by chemotherapy and radiation therapies. Orchid is the first Indian company to get an FDA approval for a non-antibiotic product.

Canadian medical device company ART (Advanced Research Technologies Inc.) announced the first sale of its SoftScan optical breast imaging system. The device was purchased by Sunnybrook Research Institute, where Dr. Gregory Czarnota would conduct a pilot study to determine the SoftScan system’s role in monitoring response to breast cancer treatment, particularly neoadjuvant therapies. SoftScan helps to monitor the response to breast cancer treatment by identifying tumors by their metabolic signatures.

Rituxan (rituximab), the blockbuster cancer drug sold by Genentech Inc. and Biogen-Idec, reduced brain lesions and their relapse in multiple sclerosis patients, according to a study published in the New England Journal of Medicine. The UCSF researchers, led by Stephen Hauser, observed 104 patients for a 48-week period. The study showed that only 20% of the patients who received Rituxan suffered from a relapse, as compared to 40% of those who received placebo.

APP Pharmaceuticals Inc. has received FDA approval for two generic dugs. The regulatory agency has approved APP Pharma’s Abbreviated New Drug Application (ANDA) for Caffeine Citrate Oral Solution, 20 mg/ml, which is a generic version of Bedford Laboratories’ Cafcit Oral Solution used for the short-term treatment of apnea in premature infants. The FDA has also approved the ANDA for bleomycin sulfate for injections, the generic version of Bristol-Myers Squibb’s cancer treatment drug Blenoxane.

European regulators have recommended the approval of thalidomide being reintroduced in the market for treating patients with a rare bone marrow cancer. Pharmion Corp. has the rights to thalidomide sales outside the U.S. The European Medicines Agency (EMEA) found that the benefits of the drug in combination with melphalan and prednisone in treating multiple myeloma blood disorders in patients over 65 years of age or ineligible for high-dose of chemotherapy far outweigh the risks related to the initial treatment. The EC usually follows the recommendation of the EMEA.

The marketing approval would require Pharmion to establish a plan for preventing the sale of thalidomide to women who may be pregnant, given the drug’s severe and life-threatening effects on the unborn child.

Human papillomavirus (HPV), the sexually transmitted virus that causes cervical cancer in women, is fast becoming a major cause of oral cancer in men, according to a study published in the Journal of Clinical Oncology. The number of men becoming afflicted by the cancers of the upper throat via the HPV virus is similar to those who catch the deadly disease due to the consumption of tobacco and alcohol. According to Dr. Maura Gillison, co-author of the study, “If current trends continue, within the next 10 years there may be more oral cancers in the United States caused by HPV than tobacco or alcohol.”

Merck & Co.’s Gardasil, the only HPV vaccine in the market and approved by the FDA for young girls and women, may be filed for the FDA approval later this year for use by men.