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ISSUE 45 – DEC. 6, 2013PDF

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Wall Street Analyst Who Sounded Alarm
Over Prostate Cancer Drug Provenge In JNCI
Settles with SEC Over Shorting Dendreon Stock

The lead author of a paper that argued that the prostate cancer immunotherapy Provenge endangered lives of cancer patients has entered a settlement agreement with the Securities and Exchange Commission.

The agreement states that Marie Huber, an analyst at a hedge fund, had prepared and anonymously circulated a paper about Provenge (sipuleucel-T) at a time when her put options in Dendreon Inc., the drug’s sponsor, were about to expire.

photoNCI Urged to Boost Gastric Cancer Funding

A group of members of both chambers of Congress is urging NCI to increase funding for research in gastric cancers—the latest in a string of advocacy initiatives to carve out fiscal support for specific diseases.

photoIn Brief

  • Lenora Johnson to leave NCI Office of Communications

  • Adrienne Lang steps down as VP for executive operations at MD Anderson Cancer Center

  • Michael Foley selected to lead the Tri-Institutional Therapeutics Discovery Institute Inc.

  • Beti Thompson to present AACR Distinguished Lecture on Cancer Health Disparities

FDA News

  • Supplemental new drug application for Nexavar tablets (sorafenib) approved

  • 510(k) clearance granted to an estrogen receptor image analysis and digital read application for breast cancer

  • Aptima HPV 16 18/45 genotype assay approved

  • Priority Review granted to ramucirumab as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy

  • FDA and the European Medicines Agency grant orphan drug designation to IMAB362

20131217 - Dec. 17, 2013
Issue 44 – Nov. 22, 2013PDF

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ASCO Vying for Big Role in Big Data

Conversation with The Cancer Letter: ASCO President Clifford Hudis

The American Society of Clinical Oncology is in the final stages of developing a request for proposals for its CancerLinQ system. The RFP is expected to be issued early in 2014.

photoBiospecimen Banks Program for NCTN

Moves Forward With Approval From BSA

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.

photoPiotr Kulesza, 46, Pathologist At Northwestern,
ECOG-ACRIN, Dies in Fall After Group MeetingPiotr Kulesza, a pathologist at Northwestern University Robert H. Lurie Cancer Center, who worked with the ECOG-ACRIN Cancer Research Group, died after a fall from a hotel balcony after attending the cooperative group’s semi-annual meeting. Kulesza was 46.
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In Brief
20131203_14 - Dec. 3, 2013
ISSUE 43 – NOV. 15, 2013PDF

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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.

20131203_10 - Dec. 3, 2013
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