News

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.

The FDA has approved Talvey, a new therapy for treating multiple myeloma patients. The agency has also issued a complete response letter for avasopasem for severe oral mucositis and set a PDUFA date for a monthly MS drug.

A discussion with Jeffrey Casberg, M.S., who joined the Managed Healthcare Executive editorial advisory board in July 2023. Casberg is senior vice president of clinical pharmacy at IPD Analytics and has played a leadership role in its drug management strategy business. A pharmacist by training, Casberg has had a long career in managed care.