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 November 17, 2008 Volume 70, Number 46 

Insurers View JUPITER With Caution; Can Benefit Be Achieved With Generics?
As insurers begin to review the details of AstraZeneca's headline-making outcomes study on Crestor - the JUPITER trial - a key question is whether the benefit found can also be extrapolated to less expensive statins, including generics.    READ MORE>>
Aranesp Declines Put More Pressure On Amgen For Denosumab Success
With sales of Amgen's blockbuster anemia franchise in a freefall and competitive threats to its tumor necrosis factor inhibitor Enbrel looming, the big biotech is banking on the osteoporosis treatment denosumab to drive growth in the years ahead.    READ MORE>>
Baucus Joins Waxman In Calling For Medicaid Rx Prices For Part D Duals
Sen. Max Baucus is proposing that drug prices for dual eligible beneficiaries under the Medicare Part D program should be paid at the Medicaid rates they received before their shift to the prescription drug benefit.    READ MORE>>
 
 
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  • FDA Risk Communication Strategy May Include Overhaul Of Labeling Language
     
     
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  • Rx Injury Claims May Grow After Court Finds Brand Liable For Generic Problems
     
     
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  • FDA Offers More Flexibility on Residual Solvents in Generic Drug Applications
     
     
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  • Chart: FDA's ANDA Approvals
     
     
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  • Teva May Have To Forfeit Exclusivity For Hyzaar/Cozaar Generics
     
     
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  • REMS Audits Fall To NDA Sponsors; First Reviews Entail Rejection/Re-Review
     
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  • FDA Raising Approval Bar For NSAID/PPI Combos; Endpoints Under Review
     
     
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  • Chart: Inside JUPITER's Realm: A Closer Look At The Trial Results

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  • Justice Department seeks manufacturing injunction against Actavis
     
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  • Gardasil good for men, too
     
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  • Genomics and rare drug reactions
     
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  • HELP committee investigates FDA no-bid contract
     
     
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  • Guidance on Anti-Infective Non-Inferiority Margins May Not Be Clear-Cut
     
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  • Scientific Or Sensational? FDA’s Reasons To Hold Advisory Cmtes. Challenged
     
     
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  • Deals Of The Week: Affymetrix/Panomics, Eisai/TorreyPines, Daiichi/ArQule
     
     
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  • The 111th Congress: AstraZeneca Lobbyist Looks At Legislative Priorities
     
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  • Pharma Can Work Well With Next Congress, AstraZeneca Lobbyist Says
     
     
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  • AstraZeneca’s JUPITER Study Brings Challenges For Crestor Marketing
     
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  • New Media Is The New Frontier For Drug Promotion
     
     
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  • U.K. Seeks Flexible Drug Pricing; NICE Becomes Flexible On Value
     
     
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  • Chart: FDA Recalls
     
     
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  • Plasma Group To Seek Legislation On IVIG Access As CMS Cuts Preadmin Fee
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