20150925 - Sep 25, 2015
ISSUE 35 – SEPT. 25, 2015PDF

Information Blocking by E-Health Record Firms Threatens CancerLinQ, ASCO Says 

Congress must put an end to the emerging practice of “information blocking” by demanding that electronic health records are able to exchange data in an “interoperable” fashion, the American Society of Clinical Oncology urged at a congressional briefing.

At the briefing Sept. 15, ASCO said that some EHR companies are erecting obstacles that preclude the sharing of data contained in patient health records.

Baselga: Why I Believe NIH is On Threshold of the Largest Budget Increase in 12 Years

As congressional leaders discuss potential ways to avert a government shutdown, which could happen in less than a week if policymakers are unable to agree to a short-term continuing resolution to keep the government running beyond Sept. 30, I remain optimistic that NIH will receive its largest annual budget increase in 12 years.

After 12 years of flat funding, a significant number of members of Congress on both sides of the aisle are enthusiastically backing the NIH, which is the largest supporter of medical research in the world. Many in Congress, Republicans and Democrats alike, appear to be singing from the same song sheet about the importance of prioritizing the NIH budget.

    In Brief

    • UNC, Vanderbilt get “exceptional” scores for Cancer Center Support Grant renewal applications

    • Peter Schultz named CEO, Steve Kay named president of The Scripps Research Institute

    • Jeffrey Medin named MACC Fund Endowed Professor at the Medical College of Wisconsin 

    • Evelyn Whitlock named chief science officer at Patient-Centered Outcomes Research Institute

    • Joaquin Espinoza named associate director of science at the Linda Crnic Institute for Down Syndrome
    • Robert Schreiber, Philip Greenberg named editors-in-chief of Cancer Immunology Research
    • Christoph Zielinski named editor-in-chief of ESMO Open
    • Huntsman Cancer Institute becomes first Mediso Preclinical Imaging Center of Excellence in North America
    • SCIEX announces collaboration with Fred Hutchinson on targeted proteomics
    • Experimental Therapeutics at Mount Sinai team up with Regeneron on antibody research
    • Thomas Jefferson and GenomOncology co-developing cancer profiling system
    • Gilda’s Club Chicago, cancer organizations launch metastatic breast cancer awareness campaign
    • The Ride to Conquer Cancer raises $2.1 million for cancer research
    Drugs and Targets

    • FDA approves Varubi for chemotherapy-induced nausea

    • Roche NimbleGen introduces enhanced whole exome sequencing solution for medical and translational research

    • CTI BioPharma Corp. plans to submit NDA for pacritinib

    • Amgen Inc. and Xencor Inc. enters immunotherapy research agreement

    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