Lack of detail on data elements that would be required through the portal has stakeholders wondering if the Centers for Medicare and Medicaid Services has really found a way to make the registry requirement less of a threat to access for Alzheimer’s drugs with traditional FDA approval.

CMS said Medicare will cover anti-amyloid antibodies for early Alzheimer’s disease upon traditional approval from the US FDA if prescribed by doctors participating in a patient registry. 

Blood-collection technology firm Tasso has been recommended for certification by MDSAP. The international qualification is part of a push to offer the company’s technology in countries such as Australia and Canada, CEO Ben Casavant told Medtech Insight. 

The major’s attempt to break into Crohn’s disease and ulcerative colitis has been cut short as a highly competitive market and pipeline, intensified by the entrance of biosimilars, renders further development of brazikumab impractical.