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Merck & Co. Inc.

www.merck.com

Latest From Merck & Co. Inc.

With 5-0 Winning Streak, Bayer And J&J Move To Eliminate Remaining Xarelto Litigation

Firms want Fifth Circuit to review whether federal law preempts failure-to-warn and design-defect claims; ruling in their favor could end 20,000-plus pending US cases.

Legal Issues Policy

ViiV CEO: "We Aim To Be Top HIV Player By Mid-2020s"

ViiV CEO predicts strong pipeline and two-drug strategy will reinforces group's HIV market position and put it ahead of Gilead by the mid-2020s.

Analysis Business Strategies

Keytruda's Broad Confirmatory Trials Suggest Evolution Of US FDA’s Accelerated Approval Model

FDA’s most recent accelerated approvals for Merck’s Keytruda call for confirmatory trials in a broader patient population than the approved indications, in the latest example of FDA’s growing comfort with multi-purpose confirmatory trials in the PD-1/PD-L1 inhibitor space.

Approvals Post Market Regulation & Studies

US FDA Fine-Tunes Tecentriq, Keytruda First-Line Bladder Cancer Accelerated Approval Indications

FDA’s decision to restrict use based on the level of PD-L1 expression shows how confirmatory trials for accelerated approval can help to inform and adapt labeling. 

Approvals Post Market Regulation & Studies
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