Washington Roundup
Executive Summary
The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence's "The Gray Sheet."
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MRI For Pacer Patients: Coverage Limited To Studies
CMS has finalized a proposal from last year to cover magnetic resonance imaging scans of patients with pacemaker and defibrillator implants, but only in certain well-controlled studies, while maintaining its MRI coverage restriction for patients with the implants in all other contexts.
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.