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Drug pricing watchdog calls for increased transparency into FDA’s accelerated approval decisions

Drug pricing watchdog calls for increased transparency into FDA’s accelerated approval decisions

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Greater transparency in FDA decision-making was possibly the most common theme for stakeholders interviewed by the Institute for Clinical and Economic Review in a new report focused on strengthening the agency’s accelerated approval program.​ ​Read More

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Ionis’ antisense drug stabilizes ultra-rare disease ahead of FDA decision

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The pivotal study of zilganersen in Alexander disease missed a secondary endpoint, but analysts expect the FDA to approve the asset given the unmet need and overall data.

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Lilly exits Rigel alliance, adding to RIPK1 scrap heap

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Eli Lilly and Rigel Pharmaceuticals partnered in February 2021 to advance a pair of RIPK1 blockers, but the pharma in October last year pulled the plug on one of these programs for central nervous system indications.

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Lilly, Novo dip as proposed Medicare coverage for GLP-1 pilot thrown off balance

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Two of the biggest insurance providers have expressed reluctance to participate in the government’s BALANCE program that would have made GLP-1 drugs more affordable to patients.

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