AGP Executive Report
Last update: 11 hours agoRare disease drug approval: The European Commission has granted marketing authorisation for NEZGLYAL® (leriglitazone), the first pharmacological treatment for cerebral adrenoleukodystrophy (cALD) in the EU, for boys aged 2–12 with Gadolinium-negative brain lesions; launch is expected first in Germany by year-end, with other countries pending reimbursement talks. EU health access & pricing pressures: A separate update outlines how the U.S. Department of Commerce clarified specialty pharmaceutical exemptions under Section 232 tariffs—eligibility isn’t automatic and companies must submit product-level requests, including patient-need details, ahead of the September 29 deadline. Rett syndrome market move: Neuren Pharmaceuticals is preparing for first commercial sales in Europe after the EC approved trofinetide (Daybu) for neurobehavioural symptoms of Rett syndrome across EU member states including Liechtenstein and Norway. Public health watch: Switzerland reported 544 tuberculosis infections in 2025 (including Liechtenstein), the highest since 2018, with the rise driven largely by people of foreign origin. Health funding scandal (EU): Malta’s Passports Fund halted a €10m health-centre upgrade programme after procurement and compliance concerns, refusing to reimburse claims tied to refurbishment irregularities.
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