Denise Myshko

Articles by Denise Myshko

The assessment framework developed by Peterson Health Technology Institute and the Institute for Clinical and Economic Research will prioritize products’ clinical benefits and economic impact of digital health technologies. The companies will announce the first set of health technologies to be reviewed by mid-October.

The decision by Scripius (previously Select Health Prescriptions) was made based on the cost of Dupixent, as well as because of an increased demand to use Dupixent for mild atopic dermatitis when the primary patient population is those with moderate to severe disease.

The FDA has approved Reblozyl as first-line treatment in MDS-related anemia and the first generics of ADHD drug Vyvanse. The agency also issued a CRL for bevacizumab to treat wet AMD. Additionally, two companies have submitted supplemental applications. These include Janssen, which is seeking full approval for Balversa for urothelial carcinoma, and AbbVie, which is seeking approval of Skyrizi for ulcerative colitis.

The FDA has approved the first biosimilar of MS drug Tysabri and granted additional approvals to Abrysvo to prevent RSV in infants, to a higher dose Eylea, and to Ingrezza for a disorder associated with Huntington’s disease. The agency has also set a review date for first-in-class therapy for MDS and granted priority review to Xtandi for earlier treatment in prostate cancer.