News

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.

The rise in the volume, variety and complexity of tests holds great promise for improving healthcare for patients, but also poses challenges for providers and health plans

It was a busy week for the FDA. Regulators approved several new therapies, including the first for a rare bone disorder, a combination product for metastatic prostate cancer and a long-acting botulinum toxin for cervical dystonia, as well as an accelerated approved for multiple myeloma. The agency also set review dates for three products, including for full approval of Tarpeyo for a rare kidney disease, an additional indication for Tibsovo for myelodysplastic syndromes and a combination antibiotic for complicated UTIs.

In an episode of Managed Healthcare Executive’s “Between the Lines” video series, Leslie Cho, M.D., and Seth Shay Martin, M.D., M.H.S., discussed bempedoic acid, the CLEAR Outcomes trial and the implications for cardiovascular disease prevention.

DNA strand in a pill

Joe Pugliese, president and CEO of the patient advocacy group Hemophilia Alliance, discusses recent announcements by manufacturers of two ultra-expensive gene therapies for hemophilia that they will offer payers partial or full reimbursement if patients fail on their therapies.