M. Nielsen Hobbs
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Latest From M. Nielsen Hobbs
DTC disclosure requirements are shiny but probably not substantive; copay navigator might be weightier.
Vote slated for Tuesday; legislation is somewhat narrower than Senate-passed bill, which applies to patients with a 'life-threatening disease or condition.'
EMA safety investigation pushes decision as AbbVie, Biogen acknowledge 'characterizing the evolving benefit/risk profile … will not be possible going forward given the limited number of patients being treated.'
US health authorities, manufacturers investigating why egg-based product appears to have lower effect in adults compared to cell-based flu vaccine.
Proposed trigger changes will discourage low-quality applications, not disincentivize patent challenges, deputy commissioner suggests at generic association's annual meeting.