CMS’s final decision is that monoclonal antibodies to treat Alzheimer’s disease may only be covered in a randomized controlled trial conducted under an investigational new drug application.
Two new subsections have been added to the warning and precautious section of Zepzelca’s label to address serious adverse events that were identified during post-market monitoring.
Karthik Ganesh, CEO of EmpiRx Health, discusses how its technology and clinical focus provide strategies for patient management that results in lower costs for clients.
Medicare beneficiaries without subsidies were 35% to 50% less likely to fill their prescriptions for drugs used to treat cancers, immune system disorders, and high cholesterol.
The agency has extended the review period to address pending inspection classification at third-party secondary packaging and labeling facility. The new PDUFA date is July 14, 2022.
Genentech also announced progress in meeting the supply challenges associated with Actemra, which is currently available under an emergency use authorization.
Prior authorization and step therapy can impact compliance and outcomes, according to a survey by the Pharmaceutical Research and Manufacturers of America.
