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Ibrutinib’s Clean Label For Mantle Cell Leukemia Bodes Well For CLL Claim

This article was originally published in The Pink Sheet Daily

Executive Summary

Pharmacyclics/Janssen’s Imbruvica carries a high list price, but also patient support.

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Pharmacyclics’ Ibrutinib Scoops Another FDA Breakthrough Designation, And Pfizer Joins The Club

Pharmacyclics and partner J&J announce a third breakthrough therapy designation from FDA for ibrutinib for hard-to-treat CLL patients with the 17p deletion. Also, NIH investigators report positive Phase II data confirming single-agent activity at the AACR meeting in Washington, D.C.

Ibrutinib Results Suggest Potential To Shake Up CLL Market

Momentum builds for Pharmacyclics/J&J’s ibrutinib with release of new data at the American Society of Hematology meeting, suggesting the drug has a shot at accelerated approval in sub-populations with high unmet need and potential in a range of B-cell cancers. Profiles of competitors from Gilead and Infinity/Takeda also came into greater focus at ASH.

Making The Most Of ACOs: How Biopharma Is Adapting To New Customer Segment

ACOs have been one of the most hyped innovations in the US health care sector this decade. The buzz may be overdone, but ACOs are now established as a different—and confusing—new customer segment for pharma. How is industry adjusting?

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