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GLG News by Colorectal Oncologists (US)

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August 29, 2008
Amgen Rewords Label: Less Use of Procrit
Analysis of: Amgen Told to Reword Drug Label | www.nytimes.com
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
The FDA required Amgen to revise the label for Procrit and Aranesp so that these agents are not used until a patient's hemoglobin drops below 10 or in the setting of potentially curative therapy.
August 29, 2008
Transparency in Healthcare: How to Assess?
Analysis of: Transparency in Healthcare | www.hospitalimpact.org
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
The author argues that transparency in healthcare will be an important step forward for the consumer.
August 29, 2008
Avastin: Worth the Cost?
Analysis of: Costly Cancer Drug Offers Hope, but Also a Dilemma | www.nytimes.com
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
Avastin improves survival in colon cancer and lung cancer and improves progression free survival in breast cancer- clinically meaningful outcomes.  Yet these gains are of relatively short duration and the cost of Avastin is significant- 50,000 to 100,000 dollars per year.
August 28, 2008
NICE States Novel Therapies for Renal Cell Cancer Too Costly
Analysis of: UK Says Kidney Cancer Drugs Are Too Pricey | www.pharmalot.com
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
NICE has stated that the cost of several novel agents for the treatment of renal cell cancer including Sutent, Torisel, Avastin, and Nexavar exceeds the benefit when assessed by quality adjusted life years (QALY) gained from the therapies.
August 1, 2008
More of the Same Crackdown on Amgen's Epo Agents
Analysis of: Amgen Told to Reword Drug Label | www.nytimes.com
Author: GLG Expert Contributor
The FDA used new power to order Amgen to change its product label for its Epo Stimulating Agents (ESAs).  The new label will reflect what Medicare reimbursement guidelines have recently oulined.
July 7, 2008
One Drug Many Uses: Prove It
Analysis of: One drug, many uses. Good idea? | www.indystar.com
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
Lilly has devoted substantial energy/expense in developing Cymbalta for many indications.  Is this at the expense of developing novel agents? 
July 7, 2008
Can China Make Generics Better than They Make Toys
Analysis of: China Muscles In On The Generics Industry | www.pharmalot.com
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
Several Chinese companies are set to enter the generic drug market ove the next year.  If these agents are demonstrated to be safe, they could have a large impact on the generic drug industry.
July 7, 2008
Avastin Effecitve in Lung and Breast Cancer But is it Cost Effective?
Analysis of: Roche decision denies cancer drug to Britons | www.ft.com
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
Roche has elected not to provide information on the cost effectiveness and clinical effectiveness of Avastin in breast cancer to the medicine advisory board of the British government.  As such, the drug will not be able for first line treatment of these diseases in Britain.
June 24, 2008
Molecular Profiling for Epo Stimulating Agents: Trying to 'Stop the Bleeding'
Analysis of: New Study Probes Safety of Erythropoiesis-Stimulating Agents | www.medscape.com
Author: GLG Expert Contributor
Use of Epo Stimulating Agents (ESAs) for cancer patients have all but come to a screeching halt when a plattoon of studies came out suggesting that ESAs might actually cause more harm, notably by possibly acting as a growth factor for tumor cells.  Now, reserachers are trying to determine...
June 6, 2008
Transgene's TG4010 Vaccine for Lung Ca - Add it to the List...
Analysis of: Transgene's Therapeutic Vaccine TG4010 Meets Primary Endpoint in Non-Small Cell Lung Cancer Phase IIb Trial | www.pipelinereview.com
Author: GLG Expert Contributor
Transgene's TG4010 vaccine has a fairy elegant two-gene design.  It appears to add benefit to a standard chemo regimen in this good-sized, randomized Phase II study for advanced lung cancer.  More mature survival data will be ready by year's end.  Phase III study is being planned.  ...

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