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		search within: All Publications Medicare Drug Focus "The Blue Sheet" "The Gold Sheet" "The Gray Sheet" Medicare Guide "The Pink Sheet" "The Pink Sheet DAILY" "The Rose Sheet" "The Silver Sheet" "The Tan Sheet" Health News Daily Pharmaceutical Approvals Research Policy ALERT Washington Fax    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>>       The 111th Congress: AstraZeneca Lobbyist Looks At Legislative Priorities     Pharma Can Work Well With Next Congress, AstraZeneca Lobbyist Says       Deals Of The Week: Affymetrix/Panomics, Eisai/TorreyPines, Daiichi/ArQule       Plasma Group To Seek Legislation On IVIG Access As CMS Cuts Preadmin Fee       Rx Injury Claims May Grow After Court Finds Brand Liable For Generic Problems       Chart: FDA Recalls       Teva May Have To Forfeit Exclusivity For Hyzaar/Cozaar Generics     Breaking news from “The Pink Sheet” DAILY     Justice Department seeks manufacturing injunction against Actavis     Gardasil good for men, too     Genomics and rare drug reactions     HELP committee investigates FDA no-bid contract       REMS Audits Fall To NDA Sponsors; First Reviews Entail Rejection/Re-Review     FDA Raising Approval Bar For NSAID/PPI Combos; Endpoints Under Review       AstraZeneca’s JUPITER Study Brings Challenges For Crestor Marketing     New Media Is The New Frontier For Drug Promotion       Guidance on Anti-Infective Non-Inferiority Margins May Not Be Clear-Cut     Scientific Or Sensational? FDA’s Reasons To Hold Advisory Cmtes. Challenged       Chart: FDA's ANDA Approvals       U.K. Seeks Flexible Drug Pricing; NICE Becomes Flexible On Value       FDA Offers More Flexibility on Residual Solvents in Generic Drug Applications       Chart: Inside JUPITER's Realm: A Closer Look At The Trial Results       FDA Risk Communication Strategy May Include Overhaul Of Labeling Language

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