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Sotagliflozin Hail Mary? Lexicon Seeks Opportunity For Formal Hearing On FDA Intent To Deny Approval

Executive Summary

After complete response letter, Lexicon triggers rarely used mechanism for formal hearing, prompting US FDA to publicly list its problems with the proposed type 1 diabetes drug, for which Sanofi had originally sought approval.

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Drug Rejection Hearings Are Having A Moment At US FDA

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New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include seven new products, including the COVID-19 vaccines from AstraZeneca/Oxford University and Moderna respectively. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).

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