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Washington Post - Biden holding cancer summit to pump up support for ‘moonshot’ effort

Vice President Biden will convene a day-long cancer summit in Washington on Wednesday that will be part pep rally, part Ted talk, part wonk-a-thon — all designed to garner support for the Obama administration’s year-long initiative to advance cancer research.

The summit, expected to draw as many as 300 people from academia, industry and advocacy groups to Howard University, is billed as a way to generate new ideas to beat a disease that kills almost 600,000 Americans a year. Dozens of regional summits will take place at the same time.

Bloomberg - Breakthrough Drugs Developed, Reviewed Faster

The FDA's breakthrough therapy designation has led to shorter drug development times and shorter FDA review times, industry experts said April 12 during a Senate briefing.

Enacted in July 2012 as part of the Food and Drug Administration Safety and Innovation Act (Pub. L. No. 112-144), the breakthrough therapy designation expedites the development and review of drugs for serious or life-threatening conditions if the drug has demonstrated substantial improvement on at least one clinically significant endpoint over available therapies.

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 Scientist - The Challenges of Precision

The amount of genetic variation between cancer patients is astounding. Two people diagnosed with cancer in the same organ may, in fact, have two very different diseases. Consequently, we are now in the middle of a transition: we no longer classify cancer based solely on its tissue of origin, but also on the key mutations driving growth and spread of a patient’s tumor.

The Hill - We are cutting government regulation at the expense of patients' lives

Last week the White House released a memo, which put forth a directive that potentially threatens the future of many scientific innovations that could save patients’ lives. The memo outlined that the Office of Management and Budget (OMB) would now need to review all non-binding guidance documents from all federal agencies. These guidance documents would then be subject to a congressional vote. Guidances are intended to convey an agencies position on processes, policies and emerging questions of the field in which a specific agency regulates.

The Cancer Letter - Varian ARIA Oncology Information System awarded CancerLinQ certification

The number of electronic health record systems joining with CancerLinQ to facilitate information sharing continues to grow. CancerLinQ LLC, a wholly owned nonprofit subsidiary of the American Society of Clinical Oncology, announced Varian’s ARIA Oncology Information System is the next Electronic Health Record System to be certified by CancerLinQ after meeting criteria for interoperability and data standardization. This collaboration aims to dismantle barriers to information sharing and streamline access to CancerLinQ for oncology practices using Varian ARIA OIS.

 

Pink Sheet - Oncology Center Of Excellence Comes Of Age at US FDA

Executive Summary

Our infographic details organizational structure and management of FDA’s first inter-center institute; five of 11 associate director positions are being filled on an acting basis.

 

The US FDA Oncology Center of Excellence’s (OCE) organizational structure reflects the cross-cutting nature of the two-year old office established to expedite the development and clinical evaluation of drugs, biologics and medical devices intended to treat, diagnose or cure cancer.

 

The Cancer Letter - Trump proposal for FY2020 to slash NIH by 12 percent, NCI by 15 percent

President Donald Trump has proposed to cut $4.7 billion from the NIH budget, with almost $900 million coming out of NCI during the fiscal year 2020.

 

According to the White House’s proposal, “A Budget for a Better America: Promises Kept. Taxpayers First.” released March 11, NIH would lose 12 percent and NCI, 15 percent.

 

If Trump’s budget request is enacted, the NIH budget would shrink from $39.1 billion in FY19 to $34.4 billion in FY20. The NCI budget would be slashed to $5.2 billion, down from $6.1 billion.

 

The ASCO Post - FDA Pipeline: Assay Approval, Breakthrough Designations for AI Technology and CLL, and More

In the past week, the U.S. Food and Drug Administration (FDA) approved a companion diagnostic assay, granted Breakthrough Device and Breakthrough Therapy designations, and extended the review period of a proposed treatment. The agency also published four draft guidances and one final guidance regarding cancer trial eligibility criteria.

The Hill - FDA faces test under new chief

The newly named acting commissioner of the Food and Drug Administration (FDA) is poised to take over at a crucial time for the agency, as outgoing Commissioner Scott Gottlieb leaves an ambitious legacy largely unfinished.

 

President Trump’s decision to tap Norman Sharpless as acting commissioner of the FDA is drawing praise from health advocates, who see it as an opportunity for the agency to continue its work uninterrupted.

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