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GLG News by Oncology Reimbursement Experts (US)

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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...
November 12, 2007
Great potential for S1
Analysis of: Adjuvant Chemotherapy for Gastric Cancer with S-1, an Oral Fluoropyrimidine | content.nejm.org
Author: GLG Expert Contributor
I think this a very important advance in a tumor where there is no adequate treatment. however, we have to realize that the studies were done in japan, and the natural history of gastri  cancer in japan is quite different that gastic cancer in USA
November 9, 2007
Massive statin market misfits waiting for safe alternative!
Analysis of: Health Canada Approves Natural Supplement for Management of Cholesterol | www.therapeuticsdaily.com
Author: GLG Expert Contributor
Block buster statins have captured major hypercholesterolemia market but many canniot tolerate them. Till now good alternatives lacking till recent Canadian regulatory approval of this chitin product of crustacian exoskeleton (sounds good enough to eat). Called Cholestol and available unofficially in...
November 8, 2007
First of many topical NSAIDs can revolutionize safer treatment of common Osteoarthritis!
Analysis of: Voltaren Gel Receives US Regulatory Approval As The First Approved Topical Prescription Treatment For Pain Associated With Osteoarthritis | www.medicalnewstoday.com
Author: GLG Expert Contributor
Decades of world-wide use (outside of U.S.) of topical NSAIDs in common OA has demonstrated huge market with local efficacy on multi-product testing. Topical nsaids have been spared significant toxicity because of fractional bioavailability while achieving local pain and anti-inflammatory relief equal...
November 6, 2007
Chronic Hepatitis C therapy huge target:new monotherapy role pre-mature
Analysis of: Pharmasset Presents R7128 14-Day Monotherapy Study Results for the Treatment of Chronic Hepatitis C | www.therapeuticsdaily.com
Author: GLG Expert Contributor
Massive need for chronic hepatis C therapy: think major chunk of population endemic in China alone. Target audience in U.S. significant, alone. FDA demands for safety and efficacy will take years beyond this early phase dose trial. If monotherapy works well, impact will be enormous. Nothing to match...
Dea BelaziOctober 29, 2007
Perhaps the Most Important Reason for Exubera Failure is that No One Wanted to Pay for it
Analysis of: Pfizer Abandons Exubera, Posts 77% Earnings Decline | online.wsj.com
Author: Dea Belazi, Pharmacy Consultant, Dea Belazi, PharmD, MPH, PAHM
Pfizers failure on Exubera were not of safety issues, or complicated device, or even consumer marketing problems.  Their biggest issue that brought failure was the lack of payer coverage.  Almost no payer in the US added Exubera to their formulary or saw any value over injectable insulin...
October 26, 2007
Double or nothing: the host decides!
Analysis of: Abbott Scientists Create One Molecule With Two Antibody Functions | www.pipelinereview.com
Author: GLG Expert Contributor
Antibody specificity in complex autoimmune diseases as RA and SLE is not a zero sum game. Host responces can disease reactive versus suppressive. Introducing multiple reactive sites is "doubling down" on a more comprehensive mitigation of targets or opening a Pandora's box of new autoimmune expression....
October 26, 2007
Consider host-risk issue witth Remicade first!
Analysis of: Clinical Studies Show REMICADE® Reduces Incidence Of Bowel Surgeries In Ulcerative Colitis Patients | www.medicalnewstoday.com
Author: GLG Expert Contributor
Remicade is potent immunosuppressive effective in ulerative colitis and rheumatoid arthritis disease suppression. However, serious infection or sepsis past history, and strong cancer history should mitigate against its use as there are other non-immunosuppressive choices absent those specific risks....
October 22, 2007
Evotec: happy dreams?: TOO EARLY TO TELL
Analysis of: Evotec Reports Positive Top-Line Results in Phase II Study with EVT 201 in Elderly Insomniacs with Daytime Sleepiness | www.pipelinereview.com
Author: GLG Expert Contributor
Multiple hypnotics have come and gone so that issues of quality of initial sleep, undisturbed sleep and absence of hang over were all addressed in this small initial trial. Evotec based upon the GABA nuerotransmiter with partial agonist features is chemically attractive and the results support good...

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