publication date: Sep. 16, 2016
Issue 34 - Sep. 16, 2016
  • ODAC Slams Spectrum for Massaging Data From Two Bladder Cancer Trials

    A brief consult with an undergraduate earning a B or above in Statistics 101 might have acquainted Spectrum Pharmaceuticals executives with all the science that would have saved them from a devastating encounter with an FDA advisory committee.

    Yet, there they were, black suits and all, at a suburban Maryland conference center, watching the Oncologic Drugs Advisory Committee vote unanimously against approval of Spectrum’s bladder cancer therapy Qapzola (apaziquone). 

    During the Sept. 14 meeting, FDA officials said repeatedly that taking apaziquone, a drug chemically related to mitomycin, to ODAC wasn’t their idea.

  • White House: New Moonshot Initiatives On Clinical Trials Will Improve Speed, Access

    Vice President Joe Biden Sept. 16 announced a series of initiatives to improve the safety, accessibility, and impact of clinical research—one of the central goals of the National Cancer Moonshot Initiative.

    The programs, which span four federal entities—NCI, FDA, the Department of Health and Human Services, and NIH—would make existing clinical trial search sites more user-friendly, and ensure that results of clinical trials are shared in a timely fashion.

  • NCI Director’s Report

    Lowy: RPG Funding Increased by $100M From 2013 to 2015—150 More Grants Funded

    Research Project Grant funding at NCI has increased 25 percent, from $400 million in 2013 to $500 million in 2015, NCI Acting Director Douglas Lowy said to the National Cancer Advisory Board Sept. 7.

    NCI’s fiscal 2016 budget is $5.21 billion, an increase of $260.5 million over fiscal 2015. This represents the  first time in about three years that funding for the institute has recovered to above pre-sequestration levels.

  • Abcodia Suspends Sale of Ovarian Cancer Screening Test After FDA Communication

    Abcodia Inc., a British company that manufactures a controversial ovarian cancer screening test, said it will temporarily suspend the availability of the product in the United States.

    ROCA, also known as the Risk of Ovarian Cancer Algorithm, uses a blood test called CA-125 and patients’ history to determine their risk for developing ovarian cancer.

  • Obituary

    John Bailar, Epidemiologist and Critic of War on Cancer, Dies at 83

    John Christian Bailar III, an epidemiologist and biostatistician known for his criticism of NCI’s emphasis on treatment, died Sept. 6. He was 83.

    Bailar riffed on the bellicose language of President Richard Nixon’s “War on Cancer” to suggest that the war in question was being lost. Researchers have focused too much on treatment and not enough on prevention, he argued.

  • Obituary

    Hopkins Biologist Saul Sharkis Dies at 72; Studied Blood Stem Cells’ Role in BMT

    Saul Sharkis, a scientist who studied the biology of blood stem cells and how they could be used to treat cancer through bone marrow transplantation, died Sept. 4. He was 72.

    Sharkis was a professor of oncology at the Johns Hopkins University School of Medicine and a faculty member in the Johns Hopkins Kimmel Cancer Center for more than 40 years.

  • In Brief

    • Eric Fearon named director of the University of Michigan Comprehensive Cancer Center
    • William Kaelin, Peter Ratcliffe, and Gregg Semenza receive 2016 Lasker Award for basic medical research
    • NCI publishes full list of FY2016 SPORE grantees
    • NCCN collaborates with New Century Health to integrate Imaging Appropriate Use Criteria
    • Levi Garraway succeeds Richard Gaynor as Lilly Oncology senior vice president, Global Development & Medical Affairs
    • Brian Goldstein named chief health system officer of UW Medicine and vice president for medical affairs at the University of Washington
    • Ashani Weeratna named Ira Brind Associate Professor at the Wistar Institute
    • Thomas Imperiale named inaugural Lawrence Lumeng Professor in Gastroenterology and Hepatology at Indiana University School of Medicine
    • The Terry Fox Foundation awards $27.3 million to six Canadian research teams
    • FDA issues first warning letters for selling e-cigarettes, e-liquids and cigars to minors
    • FDA modifies dosage regimen for nivolumab (Opdivo) for the currently approved indications
    • The European Commission issues marketing authorization for lenvatinib (Kisplyx) in combination with everolimus

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