IQWiG and LSE Authors Say EU Joint Clinical Assessments Could Become a Basis for US Price Talks
A debate about who sets the evidence bar, landing the same week Germany’s health ministry proposed lowering it.
EMA
Biogen’s High-Dose Nusinersen Wins CHMP Backing for Enhanced SMA Treatment
Biogen has earned a positive CHMP opinion for its high-dose nusinersen regimen, supported by strong DEVOTE study results showing major motor improvements and reduced mortality risk in SMA patients.
Synopulse Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 10, 2025
The Week’s Biggest Shifts in Payer Strategy This week’s policy and access landscape was defined by a sweeping overhaul of U.S. Medicaid drug pricing and a widening push toward value-driven reimbursement models. CMS’ newly announced GENEROUS model, paired with Most Favored Nation (MFN) pricing agreements for GLP-1s, marks a structural shift that will reshape affordability … Read more
EMA, CHMP NOVEMBER 2025 MEETING: TEN NEW APPROVALS, FOUR INDICATION EXTENSIONS
CHMP’s November 2025 meeting delivered 10 new drug approvals, four indication extensions, and several high-profile withdrawals, highlighting continued momentum in gene therapy, oncology, immunology, and diagnostics.