Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, announced final data from a randomized, controlled Phase 2 trial of picoplatin in metastatic colorectal cancer (CRC) patients. The study met its primary objective, as picoplatin in combination with 5-fluorouracil and leucovorin (FOLPI regimen) was associated with a statistically significant reduction in neurotoxicity (p <0.004) compared to oxaliplatin given in combination with 5-fluorouracil and leucovorin (FOLFOX regimen). Results also suggested that FOLPI had similar efficacy to FOLFOX. Read the rest of this entry »

The U.S. Food and Drug Administration approved the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart. This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery. Read the rest of this entry »

Lupin Pharmaceuticals, Inc. (LPI) announced that it has received tentative approval from the US Food and Drug Administration (US FDA) for its Memantine Hydrochloride tablets, 5mg and 10mg.

Lupin’s Memantine HCl tablets are AB-rated to Namenda® tablets indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Namenda had annual sales of approximately $1.1 billion for the twelve months ended September 2009, based on IMS Health sales data. Read the rest of this entry »

In a newly published clinical trial, patients with metastatic prostate cancer who received a vaccine of harmless poxviruses engineered to spur an immune system attack on prostate tumor cells lived substantially longer than patients who received a placebo vaccine, report researchers at Dana-Farber Cancer Institute and affiliated organizations. The findings will be published by the Journal of Clinical Oncology on its Web site and later in a print edition. Read the rest of this entry »

A new guideline from the American Academy of Neurology and the Child Neurology Society finds botulinum toxin type A to be an effective treatment for spasticity, muscle tightness that interferes with movement, in children and adolescents with cerebral palsy, but poses some risk. The guideline is published in the January 26, 2010, issue of Neurology®, the medical journal of the American Academy of Neurology. Read the rest of this entry »