GLG News by Urologic Oncologists (US)
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August 25, 2008
No advancement in treatment
Analysis of: FDA Approves ALOXI(R) (Palonosetron HCl) Capsules For Prevention Of Acute Chemotherapy Induced Nausea And Vomiting | www.medicalnewstoday.com
Author: GLG Expert Contributor
Analysis of: FDA Approves ALOXI(R) (Palonosetron HCl) Capsules For Prevention Of Acute Chemotherapy Induced Nausea And Vomiting | www.medicalnewstoday.com
Author: GLG Expert Contributor
This is the 4th in its class of oral antiemetics to control acute phase CINV. It is likely to be cost-prohibitive in the company of generical ondansetron. Palonosetron's control of delayed CINV in the IV formulation makes it the better choice among it's class; therefore, losing this indication...
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
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...
November 8, 2007
Phase III Ascentar (NOVC) Study Halted - Ineffective Drug or Faulty Trial Design?
Analysis of: Novacea Halts ASCENT-2 Trial in Advanced Prostate Cancer | www.therapeuticsdaily.com
Author: Charles Ryan, Assistant Professor of Medicine, University of California, San Francisco
Phase III Ascentar (NOVC) Study Halted - Ineffective Drug or Faulty Trial Design?
Analysis of: Novacea Halts ASCENT-2 Trial in Advanced Prostate Cancer | www.therapeuticsdaily.com
Author: Charles Ryan, Assistant Professor of Medicine, University of California, San Francisco
Prior studies had suggested an improvement in survival when calcitriol was added to weekly docetaxel. The premature closure of this study ocurred due to an increased death rate in patients receiving the combination of weekly docetaxel compared to q 21 day docetaxel. Faulty trial design, and not necessarily...
June 6, 2007
Is Wyeth's Torisel Better Than Wyeth's Rapamune?
Analysis of: FDA Approves Wyeth's Torisel For Treatment Of Advanced Kidney Cancer | www.medicalnewstoday.com
Author: GLG Expert Contributor
Analysis of: FDA Approves Wyeth's Torisel For Treatment Of Advanced Kidney Cancer | www.medicalnewstoday.com
Author: GLG Expert Contributor
Torisel is a prodrug of Rapamune, Wyeth's marketed immunosuppressant product. It is possible that cost concerns could lead to use of Rapamune as a "poor man's substitute" for Torisel.
March 16, 2007
Will Satraplatin Get Approved?
Analysis of: Satraplatin Shown to Significantly Reduce Risk of Disease Progression in Advanced Hormone-Refractory Prostate Cancer Patients | www.drugnewswire.com
Author: GLG Expert Contributor
Analysis of: Satraplatin Shown to Significantly Reduce Risk of Disease Progression in Advanced Hormone-Refractory Prostate Cancer Patients | www.drugnewswire.com
Author: GLG Expert Contributor
The Satraplatin trial used an unusual endpoint, and the results may not be as good as they appear at first glance.
February 28, 2007
No surprise!
Analysis of: Threshold Pharmaceuticals Announces That a Phase 3 Clinical Trial of Glufosfamide for Treatment of Pancreatic Cancer Did Not Meet Its Primary Endpoint | pharmalive.com
Author: GLG Expert Contributor
Analysis of: Threshold Pharmaceuticals Announces That a Phase 3 Clinical Trial of Glufosfamide for Treatment of Pancreatic Cancer Did Not Meet Its Primary Endpoint | pharmalive.com
Author: GLG Expert Contributor
This is another example where a phase III trial was conducted despite minimal evidence of efficacy in phase II.
November 27, 2006
The favorite drug
Analysis of: FDA Expands Use of Herceptin for Early Stage Breast Cancer After Primary Therapy | www.ptcommunity.com
Author: GLG Expert Contributor
Analysis of: FDA Expands Use of Herceptin for Early Stage Breast Cancer After Primary Therapy | www.ptcommunity.com
Author: GLG Expert Contributor
1. Herceptin is one of the favorite drugs used by oncologists2. Optimal schedule and length is not clear3. Role of additional testing is not established4. Competition is around the corner
November 20, 2006
The drug is innocent, the management sucks
Analysis of: Cell Therapeutics: Xyotax faces more developmental delays | www.pharmaceutical-business-review.com
Author: GLG Expert Contributor
Analysis of: Cell Therapeutics: Xyotax faces more developmental delays | www.pharmaceutical-business-review.com
Author: GLG Expert Contributor
Implications:
1. Drug will be delayed further2. Abraxane and Epothilone B will be approved. 3. If management understood that approach of early 80s does not work now, the drug would be available on market years ago.
November 20, 2006
Effectiveness vs cost –effectiveness
Analysis of: NICE rejects use of cancer drug Tarceva | www.pharmaceutical-business-review.com
Author: GLG Expert Contributor
Analysis of: NICE rejects use of cancer drug Tarceva | www.pharmaceutical-business-review.com
Author: GLG Expert Contributor
1. The first working drug will not be approved because it is too expensive.2. Narrow indication: never smoker, EGFR (+) would likely be approved if submitted, but that would establish the precedent and affect many other drugs3. US regulatory authorities may follow suite.
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November 24, 2008
Gardasil will most certainly be approved for boys
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