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The FDA is revising its 20-year-old guidance on the appropriate categorization of changes in chemistry, manufacturing and controls information in approved BLAs, based on a tiered reporting system. Read More
The PTO’s Patent Trials and Appeals Board launched an inter partes review of two patents for Sanofi’s Lantus insulin glargine injection following a challenge from Mylan. Read More
Closing what it calls an “unintended loophole,” the FDA will no longer issue orphan drug designations for smaller pediatric subpopulations of more common diseases, unless certain criteria are met. Read More