Latest From Brenda Sandburg
President Biden and Congress are pressuring the agencies to change patent policies so brand manufacturers cannot delay generic and biosimilar competition to keep monopoly prices. Timeline shows how they have responded to these demands.
Peter Marks says labeling for CSL’s hemophilia B treatment adequately conveys its risks. He also denies NHF request that the label cite eligibility criteria used in clinical trials, responding to a citizen petition on the day the agency approves the therapy.
High court is to determine whether the government can dismiss an FCA complaint after initially declining to take it on. In recent years, the government has dismissed numerous qui tam suits against pharma companies in which it did not intervene.
Court finds government failed to promptly notify Gilead of its PrEP-related patent applications as required under agreements for supply of HIV drugs used in CDC studies. Whether Gilead will have to license government patents remains undecided.
Patient-Focused Drug Development Grants May Be Program’s ‘Most Significant’ Accomplishment Since 2019
US FDA has issued five grants for development of standard core clinical outcome assessments and related endpoints that can be used across disease areas and may produce more reliable data for regulatory decision-making.
Former chief medical officer’s conviction for misbranding Suboxone does not warrant mandatory exclusion from healthcare programs, complaint argues. It says individuals in similar situations, specifically former Purdue execs, were subject to permissive exclusion.