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The Cancer Letter Inc.
PO Box 9905
Washington
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publication date: Nov 20, 2015
ISSUE 43 - NOV. 20, 2015 PDF



Congressional Panel Chair Questions Whether J&J, Brigham Reported Morcellation Adverse Events to FDA

The House Committee on Energy & Commerce has stepped into a key role in the controversy over power morcellation.

At a hearing earlier this week, Rep. Tim Murphy (R-Pa.), chairman of the Subcommittee on Oversight and Investigations questioned whether Johnson & Johnson and Brigham & Women’s Hospital violated federal law by not reporting adverse outcomes resulting from power morcellation.

At the Nov. 17 hearing by the Subcommittee on Health, Murphy quizzed Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, in an apparent effort to determine whether manufacturers of power morcellators as well as hospitals that used these devices had failed to notify FDA that patients were being harmed.

Also:

CBER's All-Day Voyage into Slippery Science Ends in 18-6 Vote against Bladder Therapy

One might surmise that by the time FDA asks an advisory committee to vet an application, the questions would deal primarily with clinical utility.

By that stage in the game, advisors would be asked to discuss the outcomes, as opposed to the biological mechanisms for achieving them.

This was even before the agency’s reorganization of its oncology units more than a decade ago. In those days, small-molecule compounds went to one bureaucratic unit of the FDA Center for Drugs Evaluation and Research—while biologics, including monoclonal antibodies and growth factors, went to the Center for Biologics Evaluation and Research.

    Capitol Hill

    FDA Lists Potentially Avoidable Harms in 20 LDT Case Studies, Including Tests from Duke, Caris and Genomic Health

    Ahead of a Capitol Hill hearing this week on the role of the FDA in the regulation of laboratory-developed tests, the federal agency published a report of 20 case studies that illustrated the possible harms presented to patients when laboratories do not comply with FDA requirements.

    The case studies included LDTs such as the Target Now cancer biomarker test, developed by Caris Life Sciences Inc.; the Oncotype DX HER2 RT-PCR breast cancer test; and the Duke University Chemotherapy Assessment genetic tumor assay.

      NCI Announces Winners of Outstanding Investigator Awards

      NCI named the inaugural 43 recipients of its Outstanding Investigator Awards.

      Developed last year, the grant program provides funding to investigators with outstanding records of productivity in cancer research to support projects of unusual potential in cancer research.

      The award provides funding of up to $600,000 in direct costs each year for seven years. One goal of the award is to provide investigators with substantial time to break new ground or extend previous discoveries to advance biomedical, behavioral or clinical cancer research.

        In Brief
        • Kantoff named chair of MSKCC Department of Medicine

        • Michael Lang named CPRIT chief product development officer

        • Alexandra Levine receives award from Los Angeles County Medical Association

        • Steven Rosen receives Lifetime Achievement Award from the Israel Cancer Research Fund

        • International Cancer Genome Consortium publishes 1,200 whole cancer genome sequences online

        • ASCO publishes 11 principles for CMS payment systems

        • MD Anderson and Codiack BioSciences form research agreement

        • Pan-Mass Challenge donates $45 million to Dana-Farber

        • AARP publishes report on drug retail prices and median household income

          Drugs and Targets
        • Darzalex granted accelerated approval in multiple myeloma

        • Ninlaro first protesome inhibitor approved in multiple myeloma

        • Eli Lilly and Merck extend phase III Alimta-Keytruda study collaboration

         

        The Cancer Letter will take a publication break

        for Thanksgiving, and return Dec. 4.


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