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Advanced Therapies From Orchard & Kite Win EMA Thumbs Up

 
• By Neena Brizmohun

Novartis’s siRNA for lowering cholesterol was also among the 10 new medicines that the European Medicines Agency this week said should be approved in the EU.

Gene editing genes therapy concept with nurse and DNA lab technician medical laboratory
A gene therapy for treating metachromatic leukodystrophy could soon be approved • Source: Shutterstock

The European Medicines Agency has recommended that 10 new treatments be awarded pan-EU marketing authorization, including Libmeldy (OTL-200), Orchard Therapeutics’ gene therapy for treating metachromatic leukodystrophy (MLD), and Leqvio (inclisiran), Novartis’s potential blockbuster cholesterol lowering drug.

If approved by the European Commission, Libmeldy will be the first commercial therapy and first gene therapy for eligible patients with early-onset MLD, and inclisiran will be the first and...

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.