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Latest From Denise Peterson
Kite's CAR-T application seems to be sailing ahead without US FDA AdComm review; large employers in the US look into value-based contracting while European regulators band together on joint price negotiations; Teva is back at FDA with its EpiPen application. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.
The US has plenty of new pharma legislation, Europe has plenty of worries about EMA's Brexit move, pharmacy benefit managers give plenty more scrutiny to which products earn a place on formulary. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.
Former US FDA global regulator Howard Sklamberg joins law firm Akin Gump; PhRMA adds two VPS; more changes in personnel.
President Trump is empty-handed on health care victories so far, as initial health reform repeal efforts collapsed and the shock value of drug pricing tweets wore off. But some actions may evolve into biopharma impact further down the road.
User fee date for Portola's anticoagulant reversal agent is near, but not soon enough for Medicare's new technology payments in 2017 – while Boehringer's Praxbind gets in in time; BTG's Vistogard also gains the extra payments.
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