publication date: Dec. 19, 2014
20141219 - Dec. 19, 2014
ISSUE 47 – DEC. 19, 2014PDF

Congress Plans to Accelerate Development of Drugs, Devices

The House Committee on Energy and Commerce is spearheading legislation aimed streamlining development of drugs and medical devices. 

The bipartisan initiative, called “21st Century Cures,” was launched April 30, and is led by Rep. Fred Upton (R-Mich.), chairman of the committee, and Rep. Diana DeGette (D-Colo.), chief deputy whip.

Research Advocates Prepare to Face Republican-led Congress

The 113th Congress staggered through its final spending bill, approving $1.1 trillion in a massive “cromnibus” Dec. 13, keeping most of the federal government funded through September 2015, and locking in a half-percent increase for NIH and NCI in FY2015.

Biomedical research advocates bemoaned the modest increase in funding—$150 million for NIH and $27 million for NCI—and questioned Congress’s commitment to scientific progress. 

Half-Percent NIH, NCI Budget Raise Is Not Enough, Advocates Say

The Cancer Letter asked leaders of science and cancer advocacy groups to comment on the half-percent increases in federal funding for NIH and NCI in fiscal 2015, and on the prospects of science funding when Republicans take control of Congress in January. 

Conversation with The Cancer Letter
Is Republican Control Better Than Two-Party Stalemate?

As Congress goes into recess and Democrats relinquish their eight-year control of the Senate, advocates for biomedical research are rethinking their approaches to a political reality not observed in nearly a decade: a Republican-controlled Congress.

Jennifer Zeitzer, director of legislative relations at the Federation of American Societies for Experimental Biology, a coalition that represents 27 scientific societies and over 120,000 researchers worldwide, says she is optimistic about prospects for science funding in the 114th Congress. 

The reason: both sides have learned that stalemates benefit no one.

ACS President & COO Resigns Unexpectedly; Was Seen as Contender for CEO Position

Gregory Bontrager resigned from his position as chief operating officer and president of the American Cancer Society.

His resignation was announced in an email from ACS Chief Executive Officer John Seffrin Dec. 18. No reason for the departure was cited. 

Bontrager, who became the COO in 2007 and president in 2013, was, in effect, the society’s second-most-powerful official, and one of the engineers of its current move to a centralized structure.

The Cancer Letter is taking a Holiday Break. 

The next issue will be published on Jan. 9, 2015.

ODAC To Advise FDA on First Biosimilars Application Jan. 7

The FDA Oncologic Drugs Advisory Committee will meet Jan. 7, 2015, to discuss a biologics license application for a proposed biosimilar to Amgen Inc.’s Neupogen (filgrastim).

The biosimilar application, submitted by Sandoz Inc., will be the first such application to be filed and discussed by an FDA advisory committee. 

NCI Advisory Board Approves Three Concepts

At a meeting Dec. 2, the NCI Board of Scientific Advisors approved three concepts during a joint meeting with the National Cancer Advisory Board.

Editorial

A Record-Breaking Year for The Cancer Letter

2014 was a transformative year for The Cancer Letter. 

• We launched a new website that makes our content possible to read online without downloading PDF files. 

• We made the website “responsive,” enabling it to adapt to all screen sizes, including smartphones and tablets. Now, about a third of our readers use these devices. An app will be available shortly.

Regulatory Approvals

  • FDA expanded the approved use of Cyramza to include metastatic NSCLC
  • FDA approves Somatuline Depot Injection (lanreotide) for metastatic GEP-NETs
  • Lynparza (olaparib) and companion diagnostic approved in gBRCAm advanced ovarian cancer
  • 510(k) clearance granted to Narrow Band Imaging for bladder cancer patient
  • FDA clears Advaxis immunotherapy phase I/II trial IND application
  • Genentech submits new drug application for cobimetinibn
In Brief

  • Fabien Calvo named chief scientific officer of Cancer Core Europe

  • OSUCCC – James moves into new cancer hospital

  • MD Anderson and UnitedHealthcare launch bundled payment program

  • Ohio State University names 2014 James Hope Award winners

  • Washington University at St. Louis genome center receives $25 million pledge

  • George Washington University Cancer Institute receives $150,000 from Center for Advancing Health

  • Northwestern University’s Lurie Comprehensive Cancer Center enters research agreement with NeoGenomics Inc.

  • Oregon Health & Science University and FEI expand Living Lab for Cell Biology agreement

  • Cancer Treatment Centers of America select WIRB-Copernicus Group to help expand its clinical research program

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