Quality Progress

In a confirmatory trial, Exkivity did not meet the primary endpoint in treating patients with non-small cell lung cancer with EGFR exon 20 mutations. It will remain available while Takeda works with the FDA on withdrawal timing.

Managed Healthcare Executive's Managing Editor Peter Wehrwein, and Editor Briana Contreras, had a discussion in July with Mostafa Kamal, president and CEO of Prime Therapeutics, an organization in which Kamal acquired this position that same month.

Patient organizations should focus on how they can be the most effective by leveraging their strengths to uncover new research opportunities.

Briana Contreras, an editor of Managed Healthcare Executive, had the pleasure of catching up with MHE Editorial Advisory Board Member, Ateev Mehrotra, MD, MPH, who is a professor of healthcare policy at Harvard Medical School and an Associate Professor of Medicine and Hospitalist at Beth Israel Deaconess Medical Center.

The FDA has approved several new therapies this week, including a new two-component Pompe therapy, an extended-release drug for major depression without sexual side effects, and an eye drop for drug-induced dilation. Additionally, the agency has set review dates for several products, including odronextamab for blood cancers, sotatercept for pulmonary arterial hypertension, and Dupixent in young children with eosinophilic esophagitis.

Data from clinical trials suggest that the vast majority of the patients respond to the gene therapy for hemophilia A, says Courtney Thornburg, M.D., M.S. But there is also decreasing factor expression.