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Gilead Sciences Inc.

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Latest From Gilead Sciences Inc.

Priority Review Vouchers Post Lower Average Approval Times Than Priority NMEs

US FDA’s priority review voucher program delivers for most sponsors, a Pink Sheet analysis finds; PRVs reliably produce faster approval than priority-reviewed new drugs overall.

Review Pathway Regulation

Yet Another Myeloma CAR-T Therapy Makes It Onto EMA’s PRIME

Only two of seven applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical need to patients faster were successful last month.

Research and Development Strategies Europe

Lilly Expands Migraine Franchise With Reyvow Approval

Reyvow gives Lilly a second MOA in migraine, following the anti-CGRP biologic Emgality, and adds an acute therapy to the preventive agent approved in 2018.

Approvals Business Strategies

Gilead’s New O’Day Regime Has New R&D Structure

After several staff departures, Gilead consolidates its research arm under CEO oversight, while welcoming another Roche/Genentech alum. 
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