Wet AMD’s Problem Was Never the Drug. It Was the Injections.
Susvimo won a CHMP recommendation as Europe’s first continuous-delivery wet AMD treatment, replacing monthly eye injections with two implant refills a year.
CHMP
ADCs Graduated From Salvage to First Line, Twice in a Week
Enhertu with pertuzumab and Trodelvy with Keytruda both won CHMP opinions for first-line metastatic breast cancer, moving ADCs from last resort to standard.
Europe Backs the Cholesterol Class That Failed Four Times
Europe recommended approval for a CETP inhibitor, a class with four prior failures, on LDL-lowering trials. The outcomes trial that decides it has not read out.
NeuroPulse Wk 30: Three Orexin Programmes in Two Weeks
Lundbeck’s Fast Track makes three orexin programmes in two weeks. Plus a Duchenne filing with a January date, and a CHMP slip caused by a contract manufacturer.
OrphanPulse Wk 30: CHMP Backs a Drug It Refused Twice
Nezglyal was refused in February 2024 and again in May. This week the same committee recommended it, and children with cerebral ALD get an oral option.
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.