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GLG News by Oncology Reimbursement Experts (US)

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Taral PatelFebruary 19, 2008
Avastin In Breast cancer
Analysis of: In Second Trial, Avastin Is Found Effective in Treating Breast Cancer | www.nytimes.com
Author: Taral Patel, Oncologist, Mid Ohio Oncology Hematology Inc.
New data with low and high dose of Avastin with Taxoter
Taral PatelFebruary 19, 2008
improve Overall survival in prostate cancer
Analysis of: Dendreon Presents Data Correlating the Cumulative Potency of PROVENGE(R) to Overall Survival | www.pipelinereview.com
Author: Taral Patel, Oncologist, Mid Ohio Oncology Hematology Inc.
esults showed that PROVENGE patients experienced improved survival if they received more cells across the three doses of PROVENGE (higher cumulative TNC count (p=0.019)) or higher cumulative CD54 upregulation values (p=0.009). The effect on survival for TNCs appeared to reflect in part the patients'...
January 31, 2008
Outsourcing clinical trials is outsourcing ethical standards as the price for global profits
Analysis of: New lease on life? The ethics of offshoring clinical trials | www.ft.com
Author: GLG Expert Contributor
Outsourcing at all levels of the global economy is a reality of today's marketplace. Medical economics is a huge slice of that pie. U.S. and European standards have provided the highest basis for judging quality clinical research and development at great cost and careful effort. Thus no surprise that...
January 28, 2008
ADVANCED EOA is not so advanced...Revisiting a common old condition with new answers.
Analysis of: Advanced Erosive Osteoarthritis (EOA) | www.medscape.com
Author: GLG Expert Contributor
EOA has been well described and well known for over a half century. It is symptomatic in its inflammatory DIP/PIP erosive presentation and clinically has an end stage indistinguishable from common variety OA. Simple treatment with NSAIDs or hydroxychloroquin and contrast baths is uniformly...
Dea BelaziJanuary 28, 2008
Erythropoiesis Stimulating Agents could be further restricted by Payers (Medicare, PBMs, and Healthplans)
Analysis of: FDA Receives New Data on Risks of Anemia Drugs | www.fda.gov
Author: Dea Belazi, Pharmacy Consultant, Dea Belazi, PharmD, MPH, PAHM
Increased FDA warnings on ESAs, suchas Epogen, Procrit and Aranesp will provide payers the ability to further restrict these agents.   Restrictions will come in the form of prior authorizations and other utilization management techniques.
December 17, 2007
Synvisc-One Could Be a Blockbuster: Bet on it!
Analysis of: Genzyme Receives FDA Response Letter on Synvisc-One (TM) | www.pipelinereview.com
Author: GLG Expert Contributor
Synvisc and other short-acting hyaluronate substances are classified for their "viscosupplementation" of compromised osteoarthritis synovial fluid allowing them to be regulated in the simpler device section of FDA. The biologically active immunomodulating activities of hyaluronates, however, is well...
Taral PatelDecember 7, 2007
Avastin in breast cancer
Analysis of: F.D.A. Criticizes Avastin Use for Breast Cancer | www.nytimes.com
Author: Taral Patel, Oncologist, Mid Ohio Oncology Hematology Inc.
“On face value the data look very good,” said Buzdar, who voted with the slim (5-4) majority against the drug. In the study that was the basis of Genentech’s application, Avastin appeared to slow the progress of the disease. advanced breast cancer who had already tried other drugs. He said he’s never...
December 3, 2007
4SC pyrimadine-acting agent in RA: too little info, too soon to interpret!
Analysis of: 4SC announces initial results from its Phase IIa clinical study with SC12267 | www.pipelinereview.com
Author: GLG Expert Contributor
Initial report does not define any numbers, demographics, inclusions and exclusions related to co-therapies, co-disease, morbidities, compliance, intent-to-treat versus per-protocol outcomes differences. We are left with some marketing type observations about RA therapy and possible positive results...
November 30, 2007
HOLD ON TO YOUR WALLETS BABY BOOMERS. Looking through a prism darkly.
Analysis of: Osiris Therapeutics Announces Positive One Year Data from Chondrogen Trial for Knee Repair | www.pipelinereview.com
Author: GLG Expert Contributor
First of all, this is not a hypothesis generating study but a fishing expedition after an orthopedic procedure intervention. Maybe that's what happens when you let orthopedists loose with statistical analysis. Patients entered the study without any baseline osteoarthritis (OA) required...just a torn...
November 20, 2007
Betting on bone density and not osteosarcoma
Analysis of: FORTEO(R) Increased Spine Bone Mineral Density in Patients with Glucocorticoid-Induced Osteoporosis | www.pipelinereview.com
Author: GLG Expert Contributor
Bone density loss a known risk with exogenous corticosteroid therapy...but also sex, age, disuse, catabolic disease should factor into outcome risk for fractures as the feared outcome. Forteo(R) is currently a second line therapy for osteoporosis issues based on  cost and osteosarcoma theoretical...

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