CMS’ latest update to the list of products subject to inflation rebates in the Part B brings the total number of different products that will owe rebates in the first year of the new penalty to 64. The headlines about big savings do not match the reality of very modest liabilities for the affected manufacturers.
A total of 64 products will face rebates for inflationary price increases in the US Medicare Part B program during the first year of new penalty for manufacturers whose price increases have outpaced background rates of inflation.
The White House highlighted that number in announcing the latest update to the list of drugs in the physician-administered payment...
The European Medicines Agency is preparing to roll out simplified transparency rules for its Clinical Trials Information System in mid-2024. This article looks at what will change and the impact on the thousands of trials that are already in the system.
The numbers may be down, but Europeans will in future be able to gain access to a number of highly innovative medicines, including several products for hard-to-treat cancers, a gene therapy for severe and moderately severe hemophilia B, and two vaccines against disease caused by respiratory syncytial virus.
Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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