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GLG News by Skin Cancer Oncologists (US)

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August 5, 2008
IT'S A SHAME!
Analysis of: As Doctors Cater to Looks, Skin Patients Wait | www.nytimes.com
Author: GLG Expert Contributor
Skin care encompasses cosmetic procedures.  But those cosmetic procedures should not take priority over the medical conditions - especially since dermatologists are uniquely qualified to treat them.  I didn't go to medical school, a residency in medicine, and a fellowship in dermatology to...
Eric WhitmanApril 14, 2008
Antigenics gain approval for autologous vaccine in Russia
Analysis of: Oncophage(R) Approved in Russia for the Treatment of Intermediate-Risk Kidney Cancer | www.pipelinereview.com
Author: Eric Whitman, Medical Director, Office of Grants and Research, Atlantic Health System Inc
Oncophage is an autologous (or derived directly from a patient's own tumor cells) vaccine that may promote the generation of an effective anti-tumor immune response when re-injected into patients. Trials in melanoma and renal cell cancer failed to meet their primary endpoints and approval has not been...
Eric WhitmanApril 14, 2008
Pfizer Anti-CTLA4 antibody trial for melanoma stopped for futility
Analysis of: Pfizer Announces Discontinuation of Phase III Clinical Trial for Patients with Advanced Melanoma | pharmalive.com
Author: Eric Whitman, Medical Director, Office of Grants and Research, Atlantic Health System Inc
The Data Safety Monitoring Board halted the Phase III randomized open label trial comparing the Pfizer anti-CTLA4 antibody, tremelimumab, to "standard" (and generally ineffective) chemotherapy for metastatic melanoma. The Board has reported that there is no statistical difference between the primary...
April 14, 2008
CTLA4 Blockade in Melanoma: Where Next?
Analysis of: Pfizer Announces Discontinuation of Phase III Clinical Trial for Patients with Advanced Melanoma | pharmalive.com
Author: GLG Expert Contributor
So, now CTLA4 blockade, touted as the next big thing in melanoma, runs into the same thing as a host of other agents with promising phase II activity: failure at the phase III level.  Pfizer's randomized phase III of tremelimumab versus the fool's gold standard dacarabzine/DTIC was...
Eric WhitmanApril 8, 2008
Antisoma drug combines novel immunotherapy agent with fused targeting antibody
Analysis of: Antisoma starts phase I clinical trial of AS1409 in renal cancer and melanoma | www.pipelinereview.com
Author: Eric Whitman, Medical Director, Office of Grants and Research, Atlantic Health System Inc
This drug, which has just entered Phase I testing, is very interesting because it combines IL-12, which has shown both activity and significant toxicity, with a targeting antibody. Hopefully, this targeting antibody will minimize the toxicity of IL-12 on or in normal tissues.
Eric WhitmanApril 8, 2008
Pfizer adds to the list of late stage melanoma drug failures
Analysis of: Pfizer Ends Clinical Trial Of Melanoma Treatment | online.wsj.com
Author: Eric Whitman, Medical Director, Office of Grants and Research, Atlantic Health System Inc
The failure of this study has wide ranging implications for Pfizer and other melanoma trials. This drug, which only a few years ago caused much excitement in the melanoma oncology community, failed to show any survival benefit in this Phase III trial, when compared to standard, but generally ineffective,...
Eric WhitmanFebruary 25, 2008
FDA Correctly Approves Avastin for Breast Cancer Based on PFS Advantage
Analysis of: Genentech Clears Hurdle On Cancer Drug Avastin | online.wsj.com
Author: Eric Whitman, Medical Director, Office of Grants and Research, Atlantic Health System Inc
FDA approval of Avastin in the treatment of advanced breast cancer will have an effect on the sales of the drug, but it is not clear to me how significant that effect will be, since it is already approved in Europe and has been widely used off-label for USA breast cancer patients already. I am glad...
Eric WhitmanFebruary 20, 2008
More misleading Provenge data from Dendreon
Analysis of: Dendreon Presents Data Correlating the Cumulative Potency of PROVENGE(R) to Overall Survival | www.pipelinereview.com
Author: Eric Whitman, Medical Director, Office of Grants and Research, Atlantic Health System Inc
This data attempts, yet again, to suggest that Provenge is more effective when the cell counts are higher, and more of the cells have CD54 "helper" antigens on their surface. These data are similar to other misleading news releases about Provenge from Dendreon. This is a subset of patients from...
Eric WhitmanFebruary 5, 2008
PEG Intron goes before ODAC in March 2008
Analysis of: FDA Grants Priority Review for Schering-Plough's Peginterferon Alfa-2b for the Adjuvant Treatment of Patients With Stage III Melanoma | www.pipelinereview.com
Author: Eric Whitman, Medical Director, Office of Grants and Research, Atlantic Health System Inc
Intron-A is currently the only FDA approved medicine to treat melanoma patients without active disease but at high risk for future recurrence. On March 12, 2008, the Oncology Drug Advisory Committee (ODAC) will discuss newly available data on the effectiveness and safety profile of PEG Intron, a longer...
Eric WhitmanJanuary 23, 2008
Supreme Court makes correct decision on experimental drugs
Analysis of: No right to experimental drugs for dying patients: Supreme Court | news.yahoo.com
Author: Eric Whitman, Medical Director, Office of Grants and Research, Atlantic Health System Inc
The Supreme Court, in refusing to hear arguments in a case brought that would make it easier for patients to gain access to non-approved drugs, brought a legal end to the request of the Abigail Alliance. This suit would have circumvented the drug approval process while leading to patients receiving...

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