Dramatic transformation in the US Medicare Part D benefit design does not require any changes to CMS’ overall approach to reviewing formulary submissions from private drug plan sponsors, the agency says in its final guidance implementing the design changes for 2025.

Bernie Sanders is back at it, getting headlines for demanding immediate price cuts to Novo’s blockbuster GLP-1 brands. But behind the familiar rhetoric is a newer threat: academic research on cost-based pricing that could one day feed into the emerging Medicare ‘negotiation’ system.

Latest update to draft guidance on early Alzheimer’s drug development is the third iteration of a document first published in 2013. The history of the guidance is a reflection of structural and leadership changes in the neurology review team at FDA.

President Biden’s call to expand the US Medicare price negotiation program is naturally making headlines from his campaign-year State of the Union Address. But his call for a national cap on co-pays could be an important opportunity for industry in the years to come.

Aggressive staffing goals for FDA’s gene and cell therapy review group might not be fully achieved – but the head of CBER believes the new organization is on track to deliver on his high expectations going forward.

Biopharma industry is making some modest headway in quest to change the new US Medicare drug price process to treat drugs and biologics on equal footing. But eliminating the so-called ‘pill penalty’ would not on its own equalize the incentives for small molecule and large molecule R&D.