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Category: In the News

Inside Health Policy – Friends of Cancer Research Chair, Founder Tapped for Cancer 'Moonshot' Panel

Chair and founder of Friends of Cancer Research, Ellen Sigal, has been appointed to the National Cancer Institute’s Blue Ribbon Panel that will advise the National Cancer Advisory Board on Vice President Joe Biden’s moonshot cancer initiative. The panel will be comprised of scientific experts that will advise the advisory board on scientific opportunities to…

Pink Sheet – FDA 'Intercenter Institutes' Legislation Headed for Senate Mark-Up

The Senate Health Committee has unveiled formal legislative language to direct FDA to test consolidated medical product reviews in at least one disease area. The legislation would direct FDA to create “Intercenter Institutes” focused on specific disease areas. Each Institute would “develop and implement processes for coordination of activities, as applicable to such major disease…

CQ Roll Call – Former Venture Capitalist Tapped to Lead Cancer 'Moonshot'

Greg Simon, a former pharmaceutical executive and congressional staffer who survived cancer, was named executive director of the Obama administration’s “moonshot” cancer initiative, the White House announced Friday. In recent years Simon has worked as a venture capitalist in the biotechnology and life sciences sector. From 2009 to 2012, he served as a vice president…

The Cancer Letter – Senate Bill Gives FDA More Control Over Its Hiring, Salaries and Structure

The FDA and NIH Workforce Authorities Modernization Act was introduced in the Senate by Republican and Democratic leaders of the health committee. The bill aims to help FDA and NIH “attract top talent during this exciting time in science.” The bill, introduced by Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.), looks to improve coordination…

The Washington Post – He won his own battle against cancer. Biden just picked him to lead a war

Greg Simon was on his way to visit a friend in San Francisco in 2014 when he called his doctor to get the results of a long-overdue physical. Your cholesterol and PSA tests are fine, his doctor said. But, he added, you have leukemia. The good news — sort of — for Simon, a lawyer…

Bloomberg BNA – Senate HELP Releases First Bill for Final ‘Cures' Markup

A bipartisan bill designed to make it easier for the NIH and the FDA to recruit top scientists was introduced in the Senate March 17. The Food and Drug Administration and National Institutes of Health Workforce Authorities Modernization Act is the first bill announced for consideration April 6 when the Senate Health, Education, Labor, and…

Fierce Biotech – Study: The FDA's 'breakthrough' program is speeding up cancer approvals

Since the FDA unveiled its breakthrough therapy designation in 2012, cancer drugs brought into the program won approval roughly three months faster than other oncology therapies, according to a new study. Nonprofit group Friends of Cancer Research pored over stats from the 29 cancer drugs approved from January 2013 to December 2015. Of the 41%…

Nature – Impact of breakthrough therapy designation on cancer drug development

The FDA began implementing the breakthrough therapy designation in 2012, following the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA). Through the program, a new drug may be designated as a breakthrough therapy by the Food and Drug Administration (FDA) if it is intended to treat a serious or life-threatening disease…

Boston Globe – STAT – Senate confirms Robert Califf as new FDA chief, ending battle for top job

The confirmation fight may have been tough, but the job could be even tougher. Now that the Senate has officially approved Dr. Robert Califf as the new commissioner of the Food and Drug Administration, he’ll inherit an agency that is being pushed to approve new medical treatments more quickly without sacrificing safety — and facing…

The Toronto Star – Joe Biden’s cancer ‘moonshot’ will be far more difficult than going to the moon, experts

Days after launching his $1-billion (U.S.) cancer “moonshot” last month, U.S. Vice-President Joe Biden was already grounding his space metaphor. Biden first used the lofty analogy in October, several months after his son’s death from brain cancer. It was deployed again in January, when President Barack Obama tasked Biden with leading the White House’s “cancer moonshot task force.” At…