| Go Time for Biotech ETFs? Tom Lydon submits: The biotechnology sector kicks off its version of a "Super Bowl" today. While it doesn’t involve cocktail weiners, gallons of beer or the wave, it’s a major event that could have an impact on biotech exchange traded funds. Today kicks off the annual meeting of the American Society of Clinical Oncology (ASCO), which will run through June 8. This is the most important meeting for the biotech sector, attended not just by doctors and leaders in the biotech industry, but by biotech investors, as well.Complete Story » seekingalpha.com |
NEJM Editorial Raises Questions About Dendreon’s Cancer Vaccine Study: Biotech's Latest Mishaps The Burrill Report submits: A New England Journal of Medicine editorial is raising questions about a pivotal study of Dendreon’s (DNDN) prostate cancer vaccine Provenge. The study found that the vaccine extended survival by 4.1 months compared to placebo in men with prostate cancer that had spread who do not respond to hormone therapy. What’s raised questions about the Provenge study is that it showed no measurable effect on tumors. An editorial that ran with the study called that “surprising” and said "it is hard to understand how the natural history of a cancer can be affected without some apparent measurable change in the tumor.” It went on to suggest that the lack of tumor effect could indicate that “the results could have been influenced by an unmeasured prognostic variable that was accidentally imbalanced in study-group assignments. The U.S. Court of Appeals for the Federal Circuit has upheld a prior ruling by the U.S. District Court for the Eastern District of Michigan that found Eli Lilly’s (LLY) method-of-use patent on its cancer drug Gemzar was invalid. The patent wasn’t set to expire until mid-2013. Lilly said it strongly disagrees with the ruling and is considering legal options. Lilly said in light of the ruling it expects to maintain market exclusivity for Gemzar until November 15, 2010, but the decision will force it to modify its current 2010 financial guidance. Global sales of Gemzar were nearly $1.4 billion in 2009.Complete Story » seekingalpha.com |
Jazz FDA Panel Meeting: Leaning on the Positive Outcome Side Kaushik Paul submits:Today, the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee are expected to jointly review the marketing application of Jazz Pharmaceuticals, Inc.’s (JAZZ) JZP-6 (sodium oxybate), designed for the treatment of fibromyalgia syndrome (FMS). FMS, a condition which affects the muscles of the body, is characterized by chronic and widespread pain, severe fatigue, sleep disturbance and depression. FMS affects approximately 4 - 5 million people in the U.S., with women accounting for approximately 70% - 95% of all FMS cases. The U.S. therapeutic market for FMS currently stands at approximately $2 billion. Initial treatment protocols for this condition include pain relievers, sleeping aids and exercise. However, each of these options yield very limited efficacy. Currently, there are three approved drugs specifically indicated for FMS: Lyrica (approved in June 2007) from Pfizer, Inc. (PFE), Cymbalta (approved in June 2008) from Eli Lilly & Co. (LLY) and Savella (approved in January 2009) from Cypress Bioscience, Inc. (CYPB) and Forest Laboratories, Inc. (FRX). However, all the three drugs are associated with several side effects. Lyrica causes dizziness, somnolence (drowsiness), breathing difficulty, dry mouth, headaches, tremors, swelling of the face, lips, tongue or throat and blurred vision. Cymbalta is associated with side effects like nausea, drowsiness, dizziness, dry mouth, headache, decreased appetite, diarrhea, insomnia (sleeplessness), fatigue, agitation, painful or difficult urination and constipation. Savella is linked to side effects such as nausea, headaches, dizziness, constipation, hot flushes, insomnia, vomiting, palpitations, and dry mouth. Thus, there exists a need for a safer drug to treat FMS. In clinical trials, JZP-6 has demonstrated a good side-effect profile, promising efficacy in reducing pain and fatigue associated with FMS, and improving the daily functioning of patients. All these factors could enable the drug to become the preferred treatment option in the FMS market. If eventually approved by the FDA, we estimate the peak U.S. revenues of JZP-6 to reach approximately $300 million. (For details of the drug's clinical trial history, you can access the full event report here.Complete Story » seekingalpha.com |
Challenge to Health Law Proceeds A federal judge in Florida refused to dismiss a lawsuit by 20 states that challenges the constitutionality of the Obama administration's health-care overhaul. online.wsj.com |
Nature Made Production - Video Dietary Supplements: Quality Matters feedproxy.google.com |