The Expertise Imperative and Compliance Technology
Access to a diverse array of specialized expert inputs drives superior decisions in every organizational context: within corporations, by investors and consultancies, and within nonprofits. When decision makers are confident of their decision inputs, they can respond more quickly and creatively to challenges and opportunities.Learn more about GLG's Compliance Framework
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New data from Cook shows 94% success rate in retrieving a temporary vena caval filter at 12 weeks post implant. This new data confirms what many of us have believed; that retrievable filters can successfully and safely be removed months after implantation.
The Food and Drug Administration approved only 17 new drugs last year compared to the peak of 53 approvals a decade ago. This is a direct consequence of the Vioxx controversy after the FDA was heavily criticized for the handeling of the approval and then withdrawal of Vioxx in 2004. Drugs...
Zelnorm (tegaserod) was FDA approved for treatment of chronic constipation in women with irritable bowel syndrome.By most reports, it was marginally effective in controlling this symptom.In an analysis of 29 short term trials involving over 11,000 patients, the data showed that the risk of serious cardiovascular...
First came Vioxx, then Bextra, now...... Ibuprofen???Do all NSAIDS increase cardiovascular risk, or are we going overboard in the name of "safety"?The AHA has issued new guidance discouraging the use of both COX-2 inhibitors and regular nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with...
Neoprobe has completed the first stage of its Phase II study of its lymph node mapping agent, Lymphoseek, and is enrolling patients in the second stage of this multicenter trial.The Lymphoseek agent correctly identified lymphatic tissue in over 97% of patients.If it has positive results in this 40 patient...
The Daytrana patch (Methylphenidate transdermal system) has been associated with an increase in cardiovascular side effects as have all other forms of the drug and the label now warns about the risks of using this in patients with preexisting structural cardiac abnormalities and other serious heart...
The replacement od bare metal stents by drug eluting stents has been remarkable. Only now some 3 years later are we beginning to learn about the potential for late stent thrombosis. The Medtronic stent at 2 year analysis does not appear at least early on to be plaqued by this concern and...
Aliskiren (Tekturna) has been approved for use by the FDA.This agent has a novel mechanism (Renin inhibition) which blocks the renin-angiotensin system one step earlier than ACE inhibitors and 2 steps earlier than angiotensin receptor blockers (ARB's).By virtue of this mechanism, there is no increase...
Percutaneous valves are being developed by CoreValve. Edwards-PVT, and other manufacturers as a less invasive option for valve replacement.These valves have been shown to be technically implantable, although they have significant morbidity and mortality.They have the short term potential to increase...
The OAT trial (Occluded Artery Trial) looked at over 2000 patients with totally occluded coronary arteries who presented for treatment 3 - 28 days after their myocardial infarction.There was no significant difference in outcome in patients treated medically vs those who received angioplasty + stent...