NIH Director Collins’ Departure May Revive Patent March-In Debate
Confirmation hearing for successor will present opportunity to press the Biden administration on the patent march-in issue, but a policy change seems unlikely—unless the President feels a strong need to act on drug pricing in the absence of legislation.
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White House Science Advisor Shuffle Could Affect ARPA-H – And ‘March In’ Debate
Former NIH Director Francis Collins is returning to government as the top scientific advisor to President Biden. The post is temporary but comes at a critical time for the attempt to launch a new health innovation agency – and maybe for the direction of administrative pricing actions.
Xtandi Petition Will Give Biden Administration Chance To Weigh In On Pricing, March-In Rights
Prostate cancer patients press HHS for administrative hearing on march-in rights for patents covering Astellas’ Xtandi. While previous efforts have failed, petitioners believe they may have a shot this time around given Biden Administration and HHS Secretary Becerra’s views on the issue.
FDA’s Pazdur Believes ‘Advanced Research’ Project Could Address Trial ‘Wastefulness’
ARPA-H could be a solution to some of FDA’s long-running complaints about US clinical trial infrastructure, the agency's cancer chief says.