In a previous post, BluePath reported on the FDA elimination of REMS programs for all currently approved BCMA- and CD19-directed autologous CAR-T cell therapies. The removal of the REMS programs...
What platforms are biopharmaceutical manufacturers using to disseminate healthcare economic information (HCEI) and Food & Drug Administration Modernization Act (FDAMA) resources? Historically, standard static formats—such as PDFs, Excel models, and...
This is the second in a series of posts in which BluePath will examine biopharmaceutical net pricing dynamics as they relate to the US physician-administered drug (PAD) market. In our...
This is the first in a series of posts in which BluePath will explore biopharmaceutical pricing dynamics as they relate to the physician-administered drug (PAD) market in the US. PAD...
The Centers for Medicare and Medicaid Services (CMS) recently announced the next 15 brand drugs which have been selected for Medicare Part D price negotiation in Initial Price Applicability Year...
In 2021, Medicare spending for Part B drugs was $43 billion and Part B drug spending has grown 9% per year on average since 2009. These trends have come to...
The US Food and Drug Administration (FDA) has proposed that manufacturers of biosimilar drugs seeking the agency’s interchangeable designation will no longer be required to perform switching studies. Current Biosimilar Interchangeability...
Research on positive symptoms of schizophrenia is well documented; however, cognitive, and negative symptoms of the illness have no approved therapies. Attaining clinical stability is of paramount importance. Nevertheless, outcomes...
Overview Health & Human Services announced on August 15 that the Center for Medicare and Medicaid Services (CMS) reached final agreements for new and lower drug prices for the initial ten...
CMS recently released proposed Contract Year 2025 Medicare payment rates for hospital outpatient and ambulatory surgical center sites of care. The 60-day comment period is now open, and interested parties...
