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Lilly CEO Breaks From PhRMA, Innovators With Support For CREATES Act

Executive Summary

Legislation that would prevent REMS from blocking generics appears to be gaining momentum.

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Reducing Patents Gets Attention From House Freedom Caucus At Pricing Hearing

House Oversight Committee Ranking Member Jim Jordan suggests that Congress may need to re-evaluate the length of pharma patents and FDA exclusivities.

CREATES Act To Face Major Reshaping By Innovator-Friendly Amendments On Senate Floor

The Creating and Restoring Equal Access to Equivalent Samples Act clears US Senate Judiciary Committee.  During markup, Sens. Hatch, R-Utah, and Cornyn, R-Tex., preview future amendments that would benefit innovators.

Shared REMS: US FDA Wants Brisk Brand-Generic Talks, Might Give Unilateral Waivers

New draft guidances are an attempt to curb abuse of REMS single shared system process to delay generic entry.

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