Medical Product Guide» Oncology products

Roxane Receives FDA Approval For Anastrozole Tablets

Jim Marino — Fri, 09 Jul 2010 19:14:49 +0000

Roxane Laboratories has received approval of its Abbreviated New Drug Application (ANDA) for Anastrozole Tablets, 1mg by the FDA. The product is available in bottles of 30 for immediate shipment to wholesalers and pharmacies across the US. Roxane Laboratories’ Anastrozole Tablets are AB rated to ARIMIDEX® (anastrozole) tablets.

TetraLogic Pharmaceuticals Initiates Phase 1 Clinical Trial Of TL32711 In Patients With Refractory Solid Tumors Or Lymphoma

Jim Marino — Mon, 18 Jan 2010 15:30:57 +0000

TetraLogic Pharmaceuticals announced that the Company has completed dosing of the first cohort in a Phase 1 clinical trial of its selective SMAC mimetic, TL32711. The Phase 1 trial is an open-label, dose-escalation study evaluating the safety and tolerability of TL32711 in adults with solid tumors or lymphoma refractory to standard therapies. The study will also assess the pharmacokinetics, pharmacodynamics and anti-tumor activity of TL32711.

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Dilon Technologies receives CE Marking for high-resolution gamma camera

Jim Marino — Tue, 13 May 2008 16:52:49 +0000

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.

Patent issued for Abviva breast cancer test

Jim Marino — Wed, 05 Mar 2008 17:38:00 +0000

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 commences evaluation of NIRS DRE system

Jim Marino — Tue, 04 Mar 2008 14:51:40 +0000

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.

FDA clears CellSearch test for metastatic prostate cancer

Jim Marino — Mon, 03 Mar 2008 19:36:30 +0000

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 receives FDA nod for generic Kytril

Jim Marino — Mon, 25 Feb 2008 15:11:50 +0000

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.

ART sells first SoftScan optical breast imaging system

Jim Marino — Fri, 22 Feb 2008 15:21:07 +0000

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 reduces relapses in MS

Jim Marino — Fri, 22 Feb 2008 15:18:15 +0000

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 receives FDA nod for its two generics

Jim Marino — Mon, 11 Feb 2008 17:41:31 +0000

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.