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When Older Drivers Excel Though younger drivers are widely believed to have quicker reaction times, drivers with more experience behind the wheel are more aware of potential hazards of the road. online.wsj.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 |
Three Biotech Stocks With Pending News Developments, Catalysts M.E. Garza submits: As always, we are chasing several stories and hearing whispers that may be of interest to readers. The first of these involves Access Pharmaceuticals, Inc. (ACCP.OB). The word on the street is that the company is getting ready to announce its first commercial order for MuGard. The order should bring the company close to $1 million in revenue and could come as part of that exclusive specialty distribution deal that Access signed with BioScrip (BIOS) in July. Access has been given comprehensive access to BioScrip's nationwide distribution platform, which includes extensive physician relationships, over 100 specialty pharmacies, a mail distribution network and more. If the rumor is true, this will be a significant step for Access, because it will mark a new phase for the company.Patients who have been waiting for this FDA-approved oral wound rinse will be the real winners, of course. MuGuard has been used by many very effectively for the management of oral mucositis, a painful inflammation and ulceration of the mucous membranes which is a debilitating side effect of radiation treatment and chemotherapy. Zacks Investment Research recently issued an update summarizing some of the recent positive developments at Access and they reiterated an 'Outperform' rating with a six-twelve month price target of $8.00. The stock closed Monday's session at $1.95 +0.02 (1.04%) and charts show a 52-week high of $3.70.Complete Story » seekingalpha.com |
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