AGP Executive Report
Last update: 11 hours agoRare disease breakthrough: The European Commission has granted marketing authorization under exceptional circumstances for NEZGLYAL® (leriglitazone) to treat male cerebral adrenoleukodystrophy (cALD) patients aged 2–12 with Gd-negative brain lesions—described as the first pharmacological option for early cALD in the EU, with a Germany launch expected by year-end and wider access depending on national reimbursement talks. Cancer care update: The EMA’s CHMP issued a positive opinion for perioperative pembrolizumab (Keytruda) plus enfortumab vedotin (Padcev) for adults with resectable muscle-invasive bladder cancer, including a subcutaneous pembrolizumab option; the European Commission decision is expected in Q4 2026 for EU countries including Liechtenstein. Public health watch: Switzerland reported 544 tuberculosis infections in 2025, the highest since 2018, with the rise driven mainly by people of foreign origin; the reporting rate climbed to 6.0 per 100,000. Policy & access: A U.S. Commerce clarification outlines how specialty pharmaceutical tariff exemptions work under Section 232, stressing that eligibility isn’t automatic and product-level requests are needed ahead of the September 29 deadline.
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