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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.

Regulatory Focus

The US Food and Drug Administration (FDA) announced Monday that Dr. Amy Abernethy will replace Rachel Sherman as Principal Deputy commissioner of Food and Drugs – the highest position at the agency that is not a political appointee.

Pink Sheet - Has R&D Productivity Rebounded? US FDA Officials Think So

Executive Summary

Record-setting pace of NME approvals is a cause for celebration. But is it a sign that drug industry R&D productivity has actually improved? The US FDA’s top drug review official thinks so – but the data aren’t yet clear.

 

The US Food & Drug Administration is already in record territory with 55 new molecular entity/novel biologic approvals already in 2018, with almost three weeks still left in the year.

 

Disability Scoop - Drugs In The Works To Treat Autism’s Core Symptoms

Federal regulators put two experimental drugs targeting autism’s core symptoms on a fast track for testing and approval this year, but they’re still a long way from pharmacy shelves.

 

Pink Sheet - Four Rules For Being A Consistent US FDA Reviewer From Peter Stein

Executive Summary

Amid concerns Office of New Drugs reorganization will result in sponsors receiving conflicting advice, new director offers several items already contemplated to prevent such problems.

 

The US FDA's Office of New Drugs wants external stakeholder oversight to accompany standardization and other internal efforts to ensure reviewer consistency after its reorganization.

 

Journal of Clinical Pathology - NCI Updates Clinical Trial Criteria in Favor of Precision Medicine

The National Cancer Institute (NCI) updated its clinical trial criteria to allow patients with specific health concerns to participate in NCI-funded clinical trials, as well as provide opportunities for patients younger than 18 years to take part in adult cancer trials.

 

Health IT Analytics - NCI Supports Precision Medicine with Updated Clinical Trial Criteria

The National Cancer Institute (NCI) has revised its clinical trial protocol template to expand eligibility criteria for cancer clinical trials. The updated criteria will allow patients with certain health conditions to participate in NCI-funded trials, as well as provide opportunities for patients younger than 18 to take part in adult clinical trials under certain circumstances.

 

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