Latest News From "The Pink Sheet" DAILY - FDA Tells Congress It Needs More Authority Over Drug Safety

REMS In Review: FDA's Sharfstein Sees Need For Additional Authority

House committee members talk Rx safety with the agency's principal deputy commissioner as they consider a path forward for a drug import safety measure.   read more

 

Insurers Push For Enhanced Medical Cost Controls In Health Reform Legislation

AHIP will return to the health reform debate with proposals for increased medical cost control measures, AHIP President Karen Ignagni said during the group's national policy forum March 10.   read more

 

Allergan's Off-Label Suit Against FDA Will Continue Despite Botox Approval For Spasticity

Allergan is continuing to press for a court order that FDA's restrictions on off-label promotion are unconstitutional; a court hearing in the case is set for April 26.   read more

 

Will Cabazitaxel Success Derail Other Prostate Cancer Trials?

Rival Medivation has a "Plan B" for Phase III if Sanofi-Aventis' cabazitaxel emerges as new standard of care as expected.   read more

 

CDER-Tobacco Center Joint Meeting Could Signal Talks On NRT Indications

FDA makes CDER-CTP meeting arrangements as the tobacco center prepares for the first meeting of its advisory committee.   read more

 

German Health Minister Attacks Drug Prices With Forced Rebates

Minister Roesler says he will impose rebates on patented drugs until pharma companies negotiate lower prices directly with insurers.   read more

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