BioCryst Flu Treatment’s Success May Hinge On Government Contract

Rapivab (peramivir) is company’s first FDA approval, but market opportunity is small; some analysts predict firm will focus resources on hereditary angioedema development programs.

BioCryst Pharmaceuticals Inc.’s first U.S. approval is for the flu treatment Rapivab (peramivir), but the nature of the target market – which is both limited and diffuse – creates a challenge for the small firm to use the product as a springboard for growth.

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What MAHA Means For US FDA: Prevention Is Not What You Think

 

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.

Makary’s Reorganization Decision A Turning Point For US FDA?

 

US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.

Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.