FDA
The U.S. Food and Drug Administration (FDA) approved Takeda Pharmaceutical's Orzeyful (generic name: oveporexton) for the treatment of type 1 narcolepsy, making it the first orexin receptor agonist targeting the root cause of the disease. Analysts predict its peak annual sales could reach $2 billion. Companies such as Eisai, Eli Lilly, and Alkermes are also racing to develop similar drugs, indicating significant market potential.
The U.S. Senate confirmed Erica Schwartz as CDC director on Wednesday, ending the agency's nearly year-long period without a permanent leader. During her confirmation hearing, Schwartz pledged to 'never betray science,' but some Democratic lawmakers expressed doubts about her ability to withstand political interference. The vote largely followed party lines, with the only Democrat voting in favor being Senator Tim Kaine of Virginia.
The U.S. FDA advisory committee voted 10 to 3 on Thursday to support Replimune's experimental melanoma treatment drug RP1, finding the efficacy results of its key study to be "assessable and clinically meaningful." Despite earlier concerns from FDA scientists about insufficient efficacy evidence, the majority of committee members believed that the tumor response signals observed in the refractory patient population warranted support. The FDA is expected to make a final approval decision by August 2.