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Issue 46 - Dec. 16, 2016
  • FDA Finds Lapses in Reporting of Patient Harm, Deaths Resulting from Medical Devices in Hospitals Nationwide

    After a broad survey of reporting standards at hospitals across the U.S., an FDA investigation recently concluded that the vast majority of the 17 institutions inspected did not file timely reports of injuries and deaths caused by medical devices.

    The inspections earlier this year were triggered by public scrutiny of power morcellation, a surgical procedure known to spread undetected uterine cancer via the device’s spinning blades, as well as by reports of infections associated with contaminated duodenoscopes, flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine.

  • Conversation with The Cancer Letter

    FDA: For Hospitals that Significantly Violated Federal Adverse Event Reporting Requirement, No Additional Action Necessary

    In a 17-institution inspection sparked by reports of patient harm and death resulting from power morcellators and contaminated duodenoscopes, FDA found that nearly all hospitals surveyed either failed to report adverse events or didn’t have proper reporting and documentation procedures in place.

  • Hackensack Cancer Center, MSKCC Form Business, Clinical Partnership in New Jersey

    Memorial Sloan Kettering Cancer Center and Hackensack Meridian Health announced a 10-year partnership deal that, in its initial stages, will involve developing joint standards of care that will be applied across their operations.

  • Obama Signs Cures Act, Funding Biden’s Moonshot and Boosting NIH, NCI, FDA Budgets Over 10 Years

    President Barack Obama Dec. 13 signed the 21st Century Cures Act, a bill that changes regulatory standards at FDA, slates additional research funds for NIH, and authorizes $1.8 billion over seven years for Vice President Joe Biden’s National Cancer Moonshot Initiative.

  • Editorial

    The Year of the Moonshot

    The moonshot, The Cancer Letter’s biggest area of coverage of 2016, continues into 2017.

    With the passage of the 21st Century Cures Act, the cancer moonshot initiative has been authorized at $1.8 billion over seven years. The Cures Act also authorizes $500 million over the next decade for FDA to streamline drug and device approval processes (The Cancer Letter, Dec. 10).

  • In Brief

    • Bertagnolli elected ASCO president
    • CMS abandons Medicare Part B payment experiment
    • Maki joins leadership of Northwell Health and Cold Spring Harbor
    • Neufeld named clinical director, physician-in-chief & EVP at St. Jude
    • Anderson appointed CEO of Genentech
    • Brown gives $30 million to IU immunotherapy center
    • Mulva family donates $75 million to UT Austin, MD Anderson
    • Collins receives FASEB Public Service Award
    • Proton Partners to build new cancer center at Thames Valley Science Park, UK
    • ACCC launches online resource for metastatic breast cancer
  • Drugs & Targets

    • Keytruda becomes first anti-PD-1 therapy to receive a CHMP positive opinion for previously untreated NSCLC
    • Nintedanib receives orphan drug designation for mesothelioma
    • ABTL0812 receives orphan drug designation for Pancreatic Cancer
Issue 45 - Dec. 9, 2016
  • DePinho Accepts Responsibility As MD Anderson’s Losses Grow

    Operating losses at MD Anderson Cancer Center ballooned again in October—swelling to $60.9 million on top of September’s $41.5 million.

    Losses for the first two months of fiscal year 2017 add up to $102.4 million, and the institution’s executives are scrambling to cut costs, boost revenues, and shore up faculty morale.

  • Senate Approves 21st Century Cures; CR Slates $300M for NCI and Moonshot

    The Senate approved the 21st Century Cures Act, a wide-ranging bill that authorizes $1.8 billion over seven years for cancer research as well as $500 million over the next decade for FDA to streamline drug and device approval processes.

  • Being an Acting Director, NCI’s Lowy Isn’t Required to Submit Resignation

    Doug Lowy will continue to lead NCI in his role as acting director in 2017 unless president-elect Donald Trump decides to appoint a different, new director.

  • In Brief

    • Drebin appointed chair of surgery at MSKCC
    • Brown named director of Inova Center for Drug Discovery and Development and Targeted Therapeutics
    • Vogelstein to receive the KNAW Bob Pinedo Cancer Care Award
    • Surgeon General issues report on electronic cigarettes
    • Zinner elected chair of American College of Surgeons board of regents
    • Jenkins retires from FDA Office of New Drugs
    • Tempus, Abramson Cancer Center collaborate on immunotherapy
    • Parker Institute, CRI form collaboration on neoantigens
    • AbbVie, Northwestern and Hopkins announce collaborations
    • GW launches the GW Cancer Center
    • St. Jude marathon raises $10 million
    • Coleman named VP of medical affairs at GenomOncology
    • Hesse named president, CEO of CTCA Philadelphia center
    • Hillman, Patti, Weinreb receive ACR Gold Medal
    • UT Health Northeast in Tyler, TX, joins MD Anderson Network
  • Drugs and Targets

    • Avastin plus chemo gets FDA approval for a type of ovarian cancer
    • EC Grants Conditional Approval for AbbVie’s Venclyxto for CLL
    • Amgen and Allergan seek EMA approval of biosimilar bevacizumab
    • Whole genome sequencing center established in Singapore
Issue 44 - Dec. 2, 2016
  • House Passes 21st Century Cures Act, Slating $4.8 Billion for NIH, Moonshot

    The House of Representatives has approved a revised version of the 21st Century Cures Act, a comprehensive $6.3 billion health care reform measure that would fund the National Cancer Moonshot Initiative and amend FDA standards for regulating drugs and devices.

  • Just as Feared: House Version of Cures Bill Gives Moonshot Money to NIH Director

    In an unusual move, the National Cancer Advisory Board fired off a letter urging Congress to authorize additional “moonshot” funds, and—just as importantly—to place these new funds in the NCI budget.

    The NCAB letter, dated Nov. 22, was likely motivated by insider accounts of a drive by top NIH officials to intercept these new dollars and place them under the purview of the NIH director (The Cancer Letter, Nov. 4).

  • Letter To The Editor

    Pressures Notwithstanding, MD Anderson Projects Positive Margin in Fiscal 2017

    Dear Editor,

    It was with disappointment that I read the Nov. 4 issue of The Cancer Letter. I feel it is my duty to respond to address inaccuracies that are not only potentially damaging to The University of Texas MD Anderson Cancer Center, but might unnecessarily scare patients who are coming to our institution for cancer care and hope.

  • In Brief

    • Tuveson named director of Cold Spring Harbor
    • City of Hope and Translational Genomics Research Institute to collaborate on precision medicine
    • $50 million to fund prostate cancer research among veterans
    • MSKCC to offer surgery outside Manhattan
    • NCCN guidelines & app help patients combat nausea and vomiting
    • NCCN imaging appropriate use criteria published for 15 guidelines
    • Guardant360 the preferred liquid biopsy test at Northwestern University
    • Dietrick named chief value officer at Chesapeake Urology
    • City of Hope’s Salgia receives 2016 Asclepius Award
    • Southern Research awarded NCI contract
  • Drugs & Targets

    • Darzalex receives FDA approval for multiple myleoma
    • Iclusig receives full FDA approval for CML
    • Athenex and Lilly enter clinical collaboration
    • BMS, Enterome collaborate on microbiome-derived biomarkers
    • First computer-aided detection system gets FDA approval
    • Avelumab accepted for priority review by FDA