publication date: Dec. 3, 2013
20131203_10 - Dec. 3, 2013
ISSUE 43 – NOV. 15, 2013PDF


A new kind of clinical trial that will assign patients to therapy based on molecular characteristics of their disease is being launched by a coalition of government agencies, pharmaceutical companies, and a non-government organization.

The effort, called the lung cancer “Master Protocol,” is a phase II and phase III trial that would test five drugs, assigning patients to therapy based on tumor biomarkers.

photoVarmus: “We Are Shrinking Everything” To Keep Grant Numbers Level During Cuts

As NCI digs out after the two-week shutdown of the federal government, its leadership has to contend with the prospect of another shutdown weeks away, which may kick in after the current continuing resolution expires Jan. 15, 2014.

photoFDA Grants Accelerated Approval to Imbruvica

FDA granted an accelerated approval to Imbruvica (ibrutinib) for mantle cell lymphoma patients who have received at least one prior therapy. 

Imbruvica was approved four months after submission of its New Drug Application. The agent is sponsored by Pharmacyclics Inc.

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