To aid its value assessments, ICER is interested in helping FDA understand the importance of patient-relevant outcomes and consistent endpoints across trials of drugs for the same disease.

As the president’s reelection campaign themes take shape, the administration is preparing to leverage NIH patents in ways it had previously eschewed. As with the merger oversight effort, though, the germs of the plans began earlier in Biden’s tenure.

Research takes deep dive into the implications around exempting certain orphan drugs that may qualify for the Inflation Reduction Act’s Medicare price negotiation program, including the effect of the exemption on Medicare spending and the revenue potential of those drugs.