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TOP SEARCHES: Postmenopausal Osteoporosis // Exenatide // New FDA Commissioner
In this issue
Rosiglitazone safety
Ticagrelor vs clopidogrel
Oncology drugs
Acne combination treatment
Prostate cancer drug
Key Topic Updates

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This month we would like to know...

In the valuation of oncology drugs for formulary placement and coverage, what factor would you say holds the greatest weight in your P&T evaluation processes today?

a) Survival data from RCTs
   
b) Tumor progression data from RCTs
   
c) Remission rate data from RCTs
   
d) QOL data
   
e) Side effect data
   
f) Pharmacoeconomic data
   
g) Compendia listings (eg, ASCO, NCCN)

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MARCH 12, 2010
FDA continues to closely monitor the cardiovascular safety of rosiglitazone (Avandia)
On February 22, 2010, FDA released a safety alert reminding healthcare professionals of the agency’s ongoing concerns regarding the cardiovascular safety of rosiglitazone (Avandia, GlaxoSmithKline). However, this is not the first warning the agency has posted regarding rosiglitazone and its cardiovascular safety. FDA previously released a communication to the public regarding the possible association between rosiglitazone and increased cardiovascular risk in a 2007 safety alert. More...
Ticagrelor reduces death rate in patients with adult coronary syndrome
Treatment with ticagrelor compared with clopidogrel in patients with acute coronary syndromes significantly reduced the death rate from vascular causes, myocardial infarction (MI), or stroke, according to the Study of Platelet Inhibition and Patient Outcomes (PLATO), a multicenter, randomized, double-blind trial. PLATO’s results were published in a recent issue of The New England Journal of Medicine. More...
Cancer drug approvals evaluated by government
More than 50 new indications for oncology and hematology drugs and biologics were cleared by FDA’s Office of Oncology Drug Products from 2005 to 2007. The retrospective analysis was published in the February 24, 2010, issue of the Journal of the National Cancer Institute. More...
Combination treatment may be effective in severe acne cases
Adding adapalene and benzoyl peroxide (Epiduo Gel) 0.1%/2.5% to doxycycline, 100 mg, may be an effective treatment for severe acne, according to results from a study sponsored by Galderma Laboratories. The combination is a retinoid and antimicrobial topical drug used to treat patients with acne vulgaris aged 12 and older. More...
Study drug improves survival for advanced prostate cancer
Results from a phase 3 trial by Sanofi-aventis have shown that the investigational compound, cabazitaxel, plus prednisone/prednisolone markedly enhanced overall and progression-free survival in patients with metastatic hormone-refractory prostate cancer in which the disease advanced after treatment with docetaxel-based chemotherapy. More...
Key Topic Updates
FDA Approvals
Ecallantide (Kalbitor): A plasma kallikrein inhibitor approved for the treatment of acute attacks of hereditary angioedema
FDA actions in brief, January 2010 (Ampyra, Victoza, Actemra, Tropazone, Morphine sulfate oral solution, Fluzone High-Dose)
First-time generic approvals, February 2010
In the Pipeline
FDA Pipeline preview, February 2010 (Ceftobiprole, Carglumic acid, Miglustat, Nebivolol, Myocet, Pirfenidone, Davunetide, BiovaxID, EpiCept, CP-4126)
Policy News
FDA Commissioner Hamburg builds agency's capabilities for bringing new therapies to patients
Drug pricing, safety, access to dominate agenda in the year ahead
Medication Safety
FDA finds no increased cardiovascular risk in patients using tiotropium

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