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GLG News by Oncologists Specializing in Hematologic Malignancies in the U.S.

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March 3, 2008
"RECORD" would bring record number of approved targted agents for renal cancer
Analysis of: Novartis Late-State Cancer Trial Is Stopped Early After Meeting Goal | online.wsj.com
Author: GLG Expert Contributor
the "Record" trial showed that Novatis' m-Tor inhibitor, everolimus improved progression free survival as compared to placebo in patients with advanced renal cancer who failed several other therapies including Avastin ( Genentech), Nexavar ( Bayer) and/or Sutent ( Pfizer). With The field of targeted...
February 26, 2008
Gardasil for boys: Not so tough sell!!!
Analysis of: Vaccinating Boys for Girls’ Sake? | www.nytimes.com
Author: GLG Expert Contributor
Merck's HPV vaccine, Gardasil is expected to be approved for boys to extend "herd immunity" and offer more prevention to girls from cervical cancer. This " altruistic" goal comes with benefits for boys: eradication of 90 % of genital warts cases, and possible long term prevention of anal , penile, and...
February 26, 2008
Accelerated approval for Avastin: Just the beginning
Analysis of: Genentech Clears Hurdle On Cancer Drug Avastin | online.wsj.com
Author: GLG Expert Contributor
As expected, FDA gave accelerated approval for Genetech's Avastin in metastatic breast cancer, thus requiring Genentech to do further studies to show survival benefit and confirm the PFS survival. This decision will "officially" introduces Avastin to breast cancer market, where use has been already...
February 25, 2008
Treanda Likely Big Winner in Indolent NHL
Analysis of: FDA Accepts TREANDA(R) New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma | www.pipelinereview.com
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
Treanda (Bendamustine) combines the activity of a purine analog and alkylating agent, two of the most potent cytotoxic classes in therapy of indolent NHL.  Older data from Europe as well as more recent clinical trials have confirmed the excellent activity of Treanda in indolent NHL and CLL. ...
February 22, 2008
Comment on New drug for HRPC(Hormone Refractory Prostate Cancer)
Analysis of: Hollis-Eden Pharmaceuticals Announces Filing of IND with APOPTONE(TM) in Hormone Sensitive Cancers to Commence Phase I/II Clinical Trial in Late-Stage Prostate Cancer | www.pipelinereview.com
Author: GLG Expert Contributor
1) This article is a bit confusing as in the beginning it refers to hormone sensitive disease,when in fact,later in the text,it is the HRPC(hormone refracory prostate cancer) cells that are targetted. 2)That being said,the mechanism of action and animal data look interesting and certainly worth pursuing...
February 22, 2008
Treanda will expand Cephalon's Oncology presence with other drugs on the horizon
Analysis of: FDA Accepts TREANDA(R) New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma | www.pipelinereview.com
Author: GLG Expert Contributor
Cephalon's Treanda have shown efficacy in relapsed/refractory indolent NHL and also in CLL, and is expected to get FDA approval for both indications. Cephalon currently has FDA approval for Trisenox for relapsed APL ( a less common form of AML) and is developing Lasteurinib for FLT-3 positive...
February 22, 2008
Avastin for Breast Cancer: Here Today Gone Tomorrow? No
Analysis of: Genentech has billions at stake in FDA battle | sanfrancisco.bizjournals.com
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
Avastin is often used for the treatment of stage IV breast cancer.  Based on compendia listing and published data, Avastin prolongs DFS when given in combination with a Taxane as initial breast cancer therapy.  However, this market share ay be jeopardized if the FDA fails to approve Avastin...
February 22, 2008
Previous FDA track records are against Genentech but don't disregard political activism!!!
Analysis of: Genentech has billions at stake in FDA battle | sanfrancisco.bizjournals.com
Author: GLG Expert Contributor
Historically , FDA follows the recommendations of its advisory committee, in this case to reject approval of Avastin. This is an election year but breast cancer patients and their families are strong activists, not to mention Genetech's mighty connections , so approval with restrictions , especially...
February 19, 2008
Strike One for Sutent
Analysis of: Kidney Cancer Drug Linked to Higher Rate of Heart Problems | www.washingtonpost.com
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
Several agents have recently received FDA approval for the treatment of renal cell carcinoma including Sutent, Nexavar and Torisel.  The recent study describes a 15% rate of cardiovascular toxicities in patients  receiving Sutent including heart failure.  Y+This is a higher rate than...
February 19, 2008
More Data on Avastin Benefit in Breast Cancer But Still PFS and not OS Improvement
Analysis of: Genentech’s Avastin Slows Spread Of Breast Cancer | www.pharmalot.com
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
Avastin faces a substantial hurdle when it goes before the FDA for approval in first line breast cancer therapy.  There has been much debate over the progression free survival benefit (5.5 months) but no overall survival benefit for this agent.  The newly reported European data on Avastin...

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