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Repeated trial failures in this rare disease space have given birth to new alliances – one backed by Critical Path and the other by the CureDuchenne advocacy group – that aim to model disease progression much more accurately through data sharing and rigorous analysis.

Clinical Trials Drug Approval Standards

Marathon's Bad News May Help Industry In Pricing Debate

Wall Street Journal brings Marathon Pharmaceuticals back to the front pages – but this time to report that the company is expected to shut down after a 'drug-price revolt.' The rest of the industry should hope the headline catches the President’s eye.

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BioMarin's Brineura Approval Shows FDA's Open Door For Orphan Drugs

Filing supporting Brineura was supported by a tiny, single-arm study and had no advisory committee review, the latest sign of the US regulatory agency's willingness to speed orphan drugs for serious pediatric diseases.

Rare Diseases Drug Approval Standards

Few Clouds On High-Priced, Ultra-Orphan Drug Horizon

With BioMarin's Brineura hitting the market with a $702,000 annual price tag, recent experience for other high-priced rare disease drugs supports the theory that payers will accept high costs for ultra-rare pediatric disease therapies.

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