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GLG News by Niaspan Prescribers for Raising HDL

Analysis of: U.S. veterans dept to limit Glaxo's Avandia: report (www.reuters.com)
Another large provider votes thumbs-down on Avandia.Actos remains innocent until proven guilty.
September 6, 2007
Competing against AIMHIGH
Analysis of: AstraZeneca and Abbott Announce Selection of Next-Generation Fenofibrate (ABT-335) and Crestor Fixed-Dose Combination (pharmalive.com)
This article is relevant because of the concept of combining statins with other agents is going to become the norm for "next" generation lipid agents. The question is which combo will be doctors prescribe?
Analysis of: GlaxoSmithKline updates prescribing information for Avandia in the US (www.pipelinereview.com)
With so many other medications available to help control diabetes, who will risk prescribing Avandia? 
Analysis of: Painkiller Widely Abused in South (www.washingtonpost.com)
The article is accurate about addiction but ignores  an important issue: the untreated pain in the world is bigger than the addiction issue.  The Addiction issue is a political issue(in an election year no less) and the human side of pain is real and nobody is without pain. Pain is the 5th...
Michael Davidson, MD, FACC, Director, Preventive Cardiology
Michael Davidson, MD, FACC, Director, Preventive Cardiology
The University of Chicago
Analysis of: FDA Advisory Committee on The Cardiovascular Ischemic/thrombotic Risks of Rosiglitzone (www.ncbi.nlm.nih.gov)
It appears from the breifing documents that the FDA has concerns about the CV safety of Avandia. They appear to be less concerned about the CV safety of Actos but both drugs are associated with an increase risk of heart failure. It is unknown how the Advisory Committee will vote but based on the available...
Analysis of: FDA Gives Go-Ahead to Once-Daily Valsartan-Amlodipine Combination Pill for Hypertension (www.medscape.com)
ExForge is a product that we in the hypertension business are very anxious to have available. Combination tablets have been increasing in sales very dramatically in the past few years and will soon overtake, in my opinion, single agents. Lotrel led the way toward combinations that do not include a diuretic...
June 20, 2007
Cephalon BUNK
Analysis of: Cephalon Receives FDA Approval of NUVIGIL(TM) for the Treatment of Excessive Sleepiness Associated with Three Disorders (www.pipelinereview.com)
Gee whiz, so Cephalon had isolated the enantiomer of provigil that is effetcive. This is the equivalent to AZ isoloating the s enantiomer of ompeprazole to create Nexium and lord ir over prilosec. This is no great feat chemically or pharmacologiclly. What it may mean is millions in profits for investors....
Analysis of: Over-The-Counter Weight Loss Drug Approved (abclocal.go.com)
does it work?  Is the AE profile translatable to a larger population? 
Howard Weintraub, MD, Clinical Director
New York University Medical Center
June 15, 2007
This one may hurt.
Analysis of: FDA Advisory Committee Did Not Recommend Approval Of Rimonabant (ZIMULTI(R)) For Use In Obese And Overweight Patients With Associated Risks Factors (www.medicalnewstoday.com)
It is clear that the panel felt that there was inadequate data on the psychiatric implications of rimonabant. It is a strong statement coming in the wake of the rosiglitazone mess (with strong recollections of cerivastatin and Vioxx) demonstrating that the FDA will be very finicky about approvals in...
Howard Weintraub, MD, Clinical Director
New York University Medical Center
June 15, 2007
This one may hurt.
Analysis of: FDA Advisory Committee Did Not Recommend Approval Of Rimonabant (ZIMULTI(R)) For Use In Obese And Overweight Patients With Associated Risks Factors (www.medicalnewstoday.com)
It is clear that the advisory panel is more concerned with safety in a limited population that the broader impact of obesity and its metabolic problems and acceleration of diabetes and atherosclerosis. This demonstrates the likelihood that the FDA will likely be posturing to reflect the rosiglitazone...

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