20150918 - Sep 18, 2015
ISSUE 34 – SEPT. 18, 2015PDF

A New Doubling: Advocates, NCI Seek 7% Boost for Medical Research Funding

NIH, NCI and FDA should receive budget increases of at least 7 percent a year, the 2015 Cancer Progress Report by the American Association for Cancer Research recommends.

The NCI Bypass Budget for 2017, published almost simultaneously with the AACR report, requests a series of annual 7-percent increases for NCI, which over a decade would double the institute’s budget. 

NCI Bypass Budget Calls for 7% More in 2017—and Doubling by 2026

The NCI Bypass Budget for 2017 asks for a 7-percent increase over fiscal 2016, followed by a series of annual 7-percent increases that would continue through 2026, when the institute’s budget would double.

The Bypass Budget is submitted by the NCI director to the U.S. President under a unique authority given to NCI under the National Cancer Act of 1971. Over the years, the budgets have had different functions, which reflected the priorities—and styles—of the institute directors who submitted them.

    Lowy: Increase for Cancer Center Grants Is Contingent on FY2016 Appropriations

    NCI is planning to increase funding for the Cancer Center Core Grants, Acting Director Douglas Lowy said to the National Cancer Advisory Board at a meeting Sept. 16.

    “Whatever we do, I’m not going to talk about the FY16 budget, but I just want to point out that it has not been passed, and until it is passed and until we get an increase in our appropriation, we would need to hold in abeyance the commitment for full funding for the increases in order to be fiscally responsible,” said Lowy during his second director’s report since he became acting director.

    Robert Califf Tapped for FDA Commissioner Position

    President Barack Obama nominated Robert Califf to the post of Commissioner of Food and Drugs.

    Earlier this year, Califf was named FDA Deputy Commissioner for Medical Products and Tobacco, a de facto No. 2 post at the agency. Califf, 63, is an expert in cardiology, clinical research, and medical economics.

    NCI Funds Five Teams to Work with Animal Models for Children’s Cancer

    NCI has funded five research teams to participate in its Pediatric Preclinical Testing Consortium.

    The consortium is designed to focus on preclinical models in order to help prioritize agents for entry into clinical trials.

    In Brief

    • Jones, Parwani recruited to key roles in Ohio State Wexner pathology programs

    • Broad Institute, MD Anderson Cancer Center designated as Genome Characterization Centers

    • Robin Davisson named president and CEO-elect of Melanoma Research Alliance

    • MD Anderson and Esperance Pharmaceuticals enter strategic alliance

    Drugs and Targets

    • AbbVie submits sNDA for Imbruvica in CLL Patients

    • FDA grants fast track designation to Can-Fite BioPharma Ltd.’s liver cancer drug 
    • FDA accepts Wellstat Therapeutics’ NDA for treatment of chemotherapy overdose

    • FDA and the European Medicines Agency accepts regulatory applications for Gilotrif
    • AstraZeneca and Peregrine Pharmaceuticals enter into immunotherapy clinical trial collaboration

    • ICON teams up with IBM to reduce time and costs of drug development
    20150911 - Sep 11, 2015
    ISSUE 33 – SEPT. 11, 2015PDF

    What’s in a Suffix?

    FDA’s Dilemma: How to Name Biologics

     

    After a courtroom victory against Amgen Inc. this summer, the last of the obstacles was removed for the first biosimilar agent—a white blood cell growth factor—to enter the U.S. market.

    Zarxio (filgrastim-sndz), sponsored by Sandoz Pharmaceuticals, a unit of Novartis, appeared on the U.S. market Sept. 3, offering a lower-priced alternative to the branded product, Neupogen.

    With biosimilars about to appear on the market, FDA is preparing to reconsider the manner in which these agents—as well as the reference products they copy—are named.

     

    HRSA Publishes Long-Awaited 340B Mega-Rule

    The Health Resources and Services Administration issued the long-awaited “mega-rule” intended to define who qualifies for deep discounts on drug prices under the federal 340B program.

    Established in 1992 to benefit hospitals and clinics that serve low-income and uninsured patients, the 340B Drug Pricing Program has expanded exponentially in recent years.

    GAO to Investigate Power Morcellation Harms

    The U.S. Government Accountability Office said it would investigate the controversy stemming from wide use of power morcellators, gynecological devices now known to spread undetected cancers during hysterectomies and myomectomies.

    The GAO’s Sept. 4 move comes after 12 members of Congress wrote a letter requesting an investigation.

    Obituary

    Gianni Bonadonna, 81, Pioneering Researcher

    Gianni Bonadonna, 81, a pioneering cancer researcher whose work focused on Hodgkin’s lymphoma and breast cancer, died Sept. 7.

    His death was announced by the Istituto Nazionale Tumori of Milan.

    Bonadonna research included the initial studies on the clinical efficacy of adriamycin (doxorubicin), epirubicin and bleomycin; a number of seminal trials on adjuvant and primary chemotherapy for high-risk breast cancer; as well as a combined modality for the treatment of Hodgkin’s disease—in 1972, he designed a new combination of drugs known as ABVD: adriamycin, bleomycin, vinblastine and dacarbazine.

    CVS Marks First Anniversary Of Stopping Tobacco Sales

    CVS Health marked the first anniversary of ending tobacco sales at its CVS/pharmacy locations, and released study data showing a reduction in cigarette purchases over the past year.

    The company also announced a joint initiative between CVS Health and Scholastic to launch a school-based tobacco-prevention program.

    70th Annual Lasker Awards Go To Witkin, Elledge, Allison, Medecins Sans Frontieres

    The 70th annual Lasker Awards went to: Evelyn Witkin and Stephen Elledge for basic medical research; James Allison for clinical research; and Medecins Sans Frontieres for public service.

    The awards carry an honorarium of $250,000 for each category, and will be presented Sept. 18 in New York City.

    In Brief

    • Chad Mirkin wins first Sackler Prize from the National Academy of Sciences

    • Arteaga and Alt awarded scientific prize by the American-Italian Cancer Foundation
    • Herbert Fritsche receives award from International Society of Oncology and Biomarkers

    • Trovagene launches European Trovagene Research Institute
    Drugs and Targets

    • FDA grants Priority Review to Alectinib in lung cancer

    • Janssen and Alligator Bioscience enter agreement
    • Sequenom to collaborate with UC San Diego

    • Vaccinogen enters agreement with Dublin City University over DiCAST
    • OICR and Structural Genomics Consortium make drug prototype available to the research community

    • PhRMA publishes report on U.S. drugs in development
    20150904 - Sep 4, 2015
    ISSUE 32 – SEPT. 4, 2015PDF

    UT Chancellor Mandates Unprecedented Shared Governance Structure at MD Anderson

     

    After years of turmoil and plunging morale at MD Anderson Cancer Center, the UT System took what observers describe as an unprecedented step—forming a Shared Governance Committee.

    The new structure, instituted Sept. 1, disbands the once powerful Executive Committee, thereby changing the cancer center’s top-down power structure.

    The new governance committee is designed to incorporate input from the faculty, and serve as the top advisory body to the institution’s president, Ronald DePinho.

     

    Editorial

    Judge: Amgen Can’t Depose Cancer Letter Reporter (Me)

    A federal judge ruled that Amgen Inc. cannot force me to answer questions related to a 2007 story that sparked a class action suit by investors and triggered a change in FDA regulations of erythropoiesis-stimulating agents.

    Judge Amit Mehta, of the U.S. District Court for the District of Columbia, quashed a subpoena filed by Amgen that sought information related to my reporting of a story about a critically important clinical trial showing that patients who received Aranesp did worse than patients who did not.

    NCI-MATCH Trial Opens

    ECOG-ACRIN opened the NCI-MATCH precision medicine trial, the largest, most scientifically rigorous precision medicine trial in cancer to date.

    NCI-MATCH seeks to determine whether matching certain drugs or drug combinations to people whose tumors have specific gene abnormalities will effectively treat their cancer, regardless of their cancer type.

    ASCO Updates Policy on Genetics and Genomic Testing

    The American Society of Clinical Oncology issued an updated policy statement on genetic and genomic testing for cancer susceptibility.

    Published in the Journal of Clinical Oncology, the statement reviews the ways in which new technologies are transforming the assessment and identification of inherited cancer susceptibility, and makes a series of recommendations for the optimal deployment of these technologies in oncology practice.

    Obituary

    UNMC’s Sidney Mirvish, 86

    Cancer researcher Sidney Mirvish died at age 86. His research into nitrosamines and carcinogenesis led to changes in the way lunch meats, hot dogs and sausages were made.

    Mirvish served as professor emeritus in the Eppley Institute for Research in Cancer and Allied Diseases at the University of Nebraska Medical Center, where he was faculty member for 46 years. Mirvish died due to complications following emergency surgery on Aug. 18.

    In Brief

    • Edith Mitchell named president of National Medical Association

    • Robert DiPaola, Stephen Gruber, and Candace Johnson named to AACI Board of Directors
    • NIH Director Francis Collins awarded Leadership in Personalized Medicine Award

    • Massimo Cristofanilli named associate director for precision medicine at Northwestern University Lurie Cancer Center
    • Jeffrey and W. Kimryn Rathmell appointed to leadership roles at Vanderbilt University Medical Center

    • Lois Travis named director of survivorship research program at Indiana University Simon Cancer Center

    • Rachel Humphrey named chief medical officer of CytomX

    • Donald Sheldon appointed regional president at University Hospitals

    • Keith Perry named chief information officer at St. Jude

    • Northwestern Medicine names breast cancer OncoSET program

    • CPRIT awards seven grants, totaling $23 million

    Drugs and Targets

    • FDA approves Varubi for CINV

    • European Commission grants authorization to Unituxin for pediatric neuroblastoma
    • FDA grants Orphan Designation to Toca 511 and Toca FC

    • FDA grants Orphan Designation to MTG-20
    • FDA grants Priority Review to MCNA