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Prasugrel: Blockbuster or Bust- FDA approval and Usage in Clinical Practice

February 17, 2009

Analysis of:F.D.A. Panel Endorses Lilly Blood Thinner | www.nytimes.com

The FDA will follow the recommendation of the advisory panel and approve both the 5 and 10 milligram doses of prasugrel Prasugrel will rapidly become the standard of care in the interventional commnunity in TRITON type patients as well as in non-TRITON type patients with diabetes In the immediate post approval period a switching policy will not be employed- as time goes on switching to plavix at 30 days may become the standard of care Long-term usage of prasugrel may be significantly impacted by the increased incidence and severity of bleeding along with counter-detailing highlighting the limitations of TRITON.

Use of DES to decrease

September 19, 2006

Analysis of:NEJM Articles on DES in MI | content.nejm.org

This article by itself on DES in acute MI is not critically important, as DES is the standard of care in the United States. However, a number of more recent presentations at the World Congress of Cardiology, as well as company data highlight the problem of late-stent thrombosis, which is associated with significant morbidity and MORTALITY.  

Cheaper clopidogrel to be widely used-Plavix in the Crosshairs of Formularies

August 24, 2006

Analysis of:Mixed thoughts on how generic clopidogrel might impact patients, providers | www.theheart.org

The availability of generic clopidogrel will significantly reduce the usage of branded clopidogrel.

The availability of generic clopidogrel will not increase the usage of clopidogrel, as price is likely not the major driver of compliance with clopidogrel usage; over and above this at a price point of $3 for the generic as compared to $4 for the branded will not change the landscape.

Plavix is already in the crosshairs of a number of formularies because it is a 4 billion drug and formularies are developing protocols to curtail its use.

Enormous potential of Rimonabant- Effect on the adipocyte

August 23, 2006

Analysis of:Acomplia (Rimonabant) - Investigational Agent for the Management of Obesity | www.drugdevelopment-technology.com

Rimonabant is the next mega blockbuster drug. Its mechanism of action over the long term, targeting the adipocyte, as opposed to suppressing appetite is unique. This mechanism is responsible for the varied beneficial metabolic effects seen with this agent- improved HDL, lower LDL, triglycerides and HbA1c. Over and above this the drug appears well tolerated

Torcetrapib: Impact on LDL and HDL Therapy

July 31, 2006

Analysis of:Heart Pill to Be Sold by Itself | www.nytimes.com

HDL therapy is the next frontier in treating lipid disorders. Currently available therapies to improve HDL are limited in both their efficacy at raising HDL and their tolerability. Torcetrapib represents the most exciting therapy in this space. Its development only in combination with Lipitor would have had significant impact on the entire LDL lowering market.

Impact of renin inhibitor and ARB-CCB combo across the cardiovascular continuum

July 31, 2006

Analysis of:Novartis Reports Two Heart Drugs Are Safe, Effective | online.wsj.com

Novartis reported data on ARB-CCB combo and aliskerin, with respect to efficacy in lowering blood pressure. While these agents appear effective in lowering blood pressure, their cost will represent a significant obstacle to their usage. Ongoing clinical trials of aliskerin's role in preventing target organ damage and morbidity and mortality will determine its ultimate role.

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