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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.



The National Cancer Institute broadened the criteria for participation in NCI-funded clinical trials after meetings with cancer research organizations and the FDA. The new criteria expands eligibility to include patients with brain metastases, HIV/AIDS, chronic hepatitis B, organ dysfunction and a history of hepatitis C or cancers beyond the trial’s target. It also removes barriers for patients under 18 to enroll in trials, which the FDA has said previously is a priority in promoting trial diversity.


Pink Sheet - “Lame Duck” Congress Has High Stakes For Pharma Companies

Executive Summary

Industry faces an uphill fight in a last-ditch effort to reverse the Medicare “donut hole” changes enacted at the start of 2018. At the same time, a stand-off over OTC monograph reform could have ripple effects on the plans to modernize the US


An eleventh hour stand-off in the US Senate between two GOP members is threatening to derail the enactment of two bills important to segments of the pharmaceutical industry – and the fallout could include disruption in the roll out of the new structure for FDA’s Office of New Drugs.


Pink Sheet - Project Renewal: US FDA's Plan To Update Generic Cancer Drug Labels Depends On NDA Holders

Executive Summary

Agency has targeted 40 older generic chemotherapeutics for revised labeling; FDA will develop the new labeling, which will include currently accepted uses, but needs the cooperation of reference product holders who would actually have to submit the supplement.


The US FDA is embarking on a mission to update labeling of generic chemotherapy drugs, but the initiative's success may depend upon the cooperation of reference product sponsors.


Pink Sheet - LPAD Approval Pathway Is Not Saving Antimicrobial Development

Executive Summary

US FDA and CMS explore reimbursement ideas to strengthen business case for antimicrobial development; new approval pathway likely is only needed in special situations.

Bundle of money and pack of medication tablets or drug pills, close-up. Expensive health care concept, selective focus

Pink Sheet - Off The Clock? The New Timelines Of “Real-Time Review”

Executive Summary

When is a two-week review not a two-week review? When it is part of the US FDA’s Oncology Center of Excellence “real-time review” pilot program. The “left shifted” review pilot is off to a good start, but it may be time to rethink the concept of FDA review clocks.