OrphanPulse Wk 43: Eight Months After FDA Said No, Disc’s Bitopertin Met Every Phase 3 Endpoint
APOLLO answered FDA’s doubts about a biomarker with 12.2 more hours a month in light without pain. Disc refiles by year-end.
NeuroPulse
DealPulse Signal
The Beats
Analysis
The Briefs
Canada’s Drug Agency Has Drafted a Yes on Spinraza for Adults With SMA, Four Years After Telling Provinces Not to Pay
Enhertu Won EU Approval 39 Days After Its CHMP Opinion, and Payers Now Hold a Label Wider Than the Trial
China Approved Bayer’s Asundexian, the First Factor XIa Inhibitor, on a 26% Stroke Reduction, Three Years After It Lost to Apixaban
Surgery Partners Is Selling for $5.7 Billion at $23.50 a Share, Below the $25.75 Bain Offer Its Board Rejected Last Year
New US Drugs Launched at a Median $257,000 a Year in 2025, and Only About a Third of Their Prescriptions Were Filled Within 30 Days
