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GLG News by Non-Electrophysiologist Cardiologists (US)

August 28, 2007
Angio-seal today-SS
Analysis of: St. Jude Medical Announces Japanese Approval Of The Angio-Seal STS Plus Vascular Closure Device (www.medicalnewstoday.com)
The key implications remain 1)Safety 2)Efficacy 3)Cost 4)Complications e)Outcome analysis
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: Older and cheaper pills just fine for diabetes (www.reuters.com)
Given that obesity is one of the prime causes of type II diabetes, and that an important part of the patient's treatment should be directed to weight loss which improves insulin resistance, I feel that prescribing drugs that you know will cause the patient to fail at losing weight are counterproductive. ...
Analysis of: Uncorking the Secret to a Healthy Life - Two Scientists Attempt to Control Aging Using Resveratrol, a Compound Found in Red Wine (abcnews.go.com)
Resveratrol might indeed be a block buster compound due to a variety of its properties the lease of which might be its powerful antioxidant properties. This compound probably best explains the FRENCH PARADOX, which is that despite the consumption of high fat dense caloric food consumed by rich French...
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...
Analysis of: FDA Gives Go-Ahead to Once-Daily Valsartan-Amlodipine Combination Pill for Hypertension (www.medscape.com)
Newly introduced guidelines for treatment targets in hypertensive patients target lower blood pressures than  those previously suggested by JNC.  Since it has already been demonstrated that control of BP to current targets in many hypertensives requires three or more drugs, even lower targets...
Analysis of: Combination Of Two Bronchoscopic Techniques Greatly Improves Diagnostic Yield In Peripheral Lung Lesions (www.medicalnewstoday.com)
Peripheral lung nodules have been difficult for the bronchoscopist in the past to biopsy in order to identify the etiology. Using these two techniques, which requires some increased training by the interventionalist, the bronchoscopist may be able to now diagnose malignancy vs infection to help with...
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....
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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