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ISSUE 1 – JAN. 3, 2014PDF

Who Makes This Drug?
Secretive Contract Manufacturing Arrangements Complicate Solutions to Shortages of Generics

By Rena M. Conti
The closing of Ben Venue Laboratories, a company that produces a large share of generic drugs used by America’s oncologists, brings into focus a little-understood business practice that exacerbates the problem of drug shortages and shows why the industry and federal regulators have been unable to resolve them.

photoReport to the Nation: Death Rates Continue To Decline Across All Major Disease Sites

Death rates continued to decline for all cancers combined for men and women of all major racial and ethnic groups and for most major cancer sites, according to the Annual Report to the Nation on the Status of Cancer. Rates for both sexes combined decreased by 1.5 percent per year from 2001 through 2010.

photoAn Appreciation: Janet Rowley, “Translational Research Pioneer”

Janet Rowley, a pioneer in connecting the development of cancer with genetic abnormalities, died from complications of ovarian cancer on Dec. 17 at her home. She was 88.

photoIn Brief

  • Julie Vose Elected President of ASCO
  • 2014 Breakthrough Prize Winners Announced
  • Andrea Sloan, Prominent Ovarian Cancer Patient Dies
20140103 - Jan. 2, 2014
ISSUE 46 – DEC. 13, 2013PDF

CPRIT Official Indicted for Skipping Peer Review

By Paul Goldberg
A grand jury in Travis County, Texas, indicted a former official of the Cancer Prevention and Research Institute of Texas for bypassing peer review in awarding an $11 million grant to a Dallas-based company.

photoWhy I Don’t Want to Pay for Your Horoscope:
Reflections on FDA Warning to 23andMe

Guest Editorial by Jim Evans
There’s been much recent gnashing of teeth (at least within the narrow and rather insular world of do-it-yourself genomics) about the gall of the FDA in choosing to issue a warning letter to 23andMe, effectively shutting down marketing of their direct-to-consumer personal genomic profiling. And adding to 23andMe’s woes, a class action suit has been filed against them.

photoBipartisan Deal Eases Some Budget Cuts By Extending Sequestration Through 2023

By Matthew Bin Han Ong
The House of Representatives voted 332-94 to approve a two-year budget outline Dec. 12 that would cancel $63 billion in sequester cuts for 2014 and 2015—in exchange for extending sequestration through 2023.

photoIn Brief

  • Thomas Burke stepped down as executive vice president and physician-in-chief at MD Anderson Cancer Center
  • Edward Jackson named chair of the Department of Medical Physics at the University of Wisconsin School of Medicine and Public Health
  • David Chang appointed professor of plastic surgery at the University of Chicago School of Medicine
  • Steve Mackin named chief operating officer of Cancer Treatment Centers of America
20131217_4 - Dec. 17, 2013
ISSUE 45 – DEC. 6, 2013PDF

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Wall Street Analyst Who Sounded Alarm
Over Prostate Cancer Drug Provenge In JNCI
Settles with SEC Over Shorting Dendreon Stock

The lead author of a paper that argued that the prostate cancer immunotherapy Provenge endangered lives of cancer patients has entered a settlement agreement with the Securities and Exchange Commission.

The agreement states that Marie Huber, an analyst at a hedge fund, had prepared and anonymously circulated a paper about Provenge (sipuleucel-T) at a time when her put options in Dendreon Inc., the drug’s sponsor, were about to expire.

photoNCI Urged to Boost Gastric Cancer Funding

A group of members of both chambers of Congress is urging NCI to increase funding for research in gastric cancers—the latest in a string of advocacy initiatives to carve out fiscal support for specific diseases.

photoIn Brief

  • Lenora Johnson to leave NCI Office of Communications

  • Adrienne Lang steps down as VP for executive operations at MD Anderson Cancer Center

  • Michael Foley selected to lead the Tri-Institutional Therapeutics Discovery Institute Inc.

  • Beti Thompson to present AACR Distinguished Lecture on Cancer Health Disparities

FDA News

  • Supplemental new drug application for Nexavar tablets (sorafenib) approved

  • 510(k) clearance granted to an estrogen receptor image analysis and digital read application for breast cancer

  • Aptima HPV 16 18/45 genotype assay approved

  • Priority Review granted to ramucirumab as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy

  • FDA and the European Medicines Agency grant orphan drug designation to IMAB362

20131217 - Dec. 17, 2013