JCR Gets Its Brain-Penetrating Hunter Therapy Out of Japan for the First Time, Through the UAE
IZCARGO, a therapy engineered to cross the blood-brain barrier, won its first marketing authorization outside Japan five years after launching there.
Market Access
Crysvita Reaches One-Month-Old Infants in the EU, and Buys Two More Years of Orphan Exclusivity
The European Commission approved Crysvita for infants as young as one month with XLH, a decision that also buys Kyowa Kirin two more years of orphan exclusivity.
Spain rewrites its drug-pricing rulebook, and the price of a generic will now fall as it sells more
Spain’s new draft Medicines Law will cut the price of generics and biosimilars automatically as their market share grows, replacing a system where prices froze after one initial discount.
7 Market Access Trends Reshaping Pharma by 2027
The rules of pharmaceutical market access are being rewritten. From IRA-mandated price ceilings to AI-driven outcomes contracting.
ICER Backs Wegovy, Zepbound Value in Obesity but Flags Access Crunch
The Institute for Clinical and Economic Review (ICER) has delivered a strong clinical and economic endorsement of today’s leading obesity drugs, while simultaneously warning that U.S. payers are unprepared for the scale of demand these therapies are likely to generate. In a final evidence report released Tuesday, ICER concluded that Novo Nordisk’s semaglutide (Wegovy, injectable … Read more
EU Greenlights Landmark Pharma Package, Overhauling Drug Rules for the First Time in 20 Years
The EU has finalized a sweeping Pharma Package deal, preserving eight years of data protection, adding new antibiotic incentives and giving member states new powers to secure medicine supply.
ICER Advances Two High-Stakes Assessments: Cytisinicline Cleared, IgAN Therapies Under Review
ICER released two notable updates this week: a final evidence report supporting cytisinicline’s role in smoking cessation and a draft review evaluating sibeprenlimab, atacicept and delayed-release budesonide for IgA nephropathy.
UK Cuts VPAG Newer-Medicine Rate to 14.5% for 2026
The UK has set the 2026 VPAG newer-medicine rebate at 14.5%, down sharply from 22.9% in 2025, reflecting slower NHS uptake and easing budget pressure. With an added 1% contribution, companies will pay 15.5% next year as talks begin to redesign the scheme for 2029 and beyond.
Korea Unlocks Breakthrough Access for Ultomiris and Jemperli
Korea delivered two breakthrough reimbursement decisions, opening transformative access to Ultomiris for refractory generalized myasthenia gravis and elevating Jemperli to first-line status in dMMR/MSI-H endometrial cancer.
Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 24, 2025
The Reimbursement Landscape Recalibrates As we pause for the Thanksgiving holiday, a sincere thank-you to our readers and partners for your continued engagement. This week’s update reflects a period of meaningful policymaking momentum across major global agencies. Across the U.S., UK, France, Canada and Thailand, agencies delivered firm, directional decisions that shape how hospitals, clinics … Read more