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Dealmaking (09/02)

Executive Summary

Summarizing the month in European dealmaking.

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Medtronic/Tandem Patent Agreement Paves Way For Diabetes Product Development

Tandem Diabetes Care and Medtronic have signed a patent cross-license agreement that paves the way for joint development of future diabetes products and services while avoiding potential legal disagreements.

GDUFA Sees First-Ever Fee Spending Decrease

Thanks in part to budget authority bump, US FDA’s generic user fee revenue spending dropped in FY 2019, and hiring problems lead to an FTE decrease. The useable GDUFA carryover balance also increased in conjunction with the user fee revenue spending reduction, from $158.7m available at the end of FY 2018 to $199.2m at the end of FY 2019.

EMA Presses On With Guidance On Secondary Use Of Health Data

The European Medicines Agency will use feedback from two workshops in September to clarify what data protection issues must be addressed to allow for the secondary use of health and medical data when it comes to developing, monitoring and evaluating medicines.

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