Amylyx Pharmaceuticals is formally withdrawing from the market its accelerated approval drug for amyotrophic lateral sclerosis (ALS), Relyvrio, after a Phase III clinical trial showed it failed to perform better than a placebo, the company announced Thursday (April 4). FDA approved the drug in September 2022, after its advisers initially recommended against approval but then pivoted after Amylyx submitted new analyses the company said confirmed Relyvrio’s effectiveness. But at the time both FDA and the company committed to pull the...

Updated Story: This story has been updated to include more background on the issue and to state HIV+ Hepatitis Policy Institute is exploring “legal options for patients.” The earlier version said the group was considering suing CMS. A national patient group that recently won a suit against CMS’ 2021 exchange policy allowing insurers to avoid counting drug copay assistance toward patient out-of- pocket maximums is slamming the administration for refusing to enforce that decision and is exploring...

HHS hopes to work with Congress to stem drug shortages by setting up a program to rate the quality and supply chain resiliency of generic drugs and then incentivize hospitals through Medicare payments and penalties to contract for drugs with high scores and institute programs to protect against shortages. The move comes after industry experts and generic drug lobbies pushed the idea of changing hospital buying patterns through long-term contracts that include a pay-for-performance mechanism. HHS released a white paper...