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340B Court Ruling Offers Manufacturers Short-Term Reprieve In Contract Pharmacy Dispute

 
• By Cathy Kelly

Federal court vacates enforcement letter to Lilly from HRSA, but the decision was not completely favorable to pharma. It also offers the view that the law does not allow manufacturers to restrict 340B discounts to hospitals using multiple contract pharmacies.

Court Strikes Down HRSA Enforcement Letter • Source: Alamy

Manufacturers involved in a dispute with the Health Resources and Services Administration over limiting 340B discounts on outpatient drugs to contract pharmacies have received some good news from a federal court decision in a lawsuit brought by Eli Lilly and Company against the US Health and Human Services Department.

US District Court for the Southern District of Indianapolis Judge Sarah Barker concluded that a 17 May enforcement letter from...

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EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

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• By Mandy Jackson and Joseph Haas

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