We went through our analytics: here is what your colleagues in oncology read in 2019. What are your colleagues reading in The Cancer Letter? Here are the highlights: Robert Peter Gale’s series on the HBO show ‘Chernobyl’ was read around the globe, and one piece was translated into Russian, Robotic mastectomies performed at New…
In its continuing efforts to help ensure that patients receive the best treatments in the safest and fastest way possible, the Friends of Cancer Research (FOCR) announced a new pilot project called ctMoniTR at its annual meeting, held in Washington, D.C. The pilot project aims to harmonize the use of circulating tumor DNA (ctDNA)—genetic material…
A major cancer research advocacy organization wants key House lawmakers to include in their upcoming Cures 2.0 package a policy that would give FDA authority to require generic drug labels be updated to reflect new information about the drug and its use. The request is one of several proposals Friends of Cancer Research (FOCR)…
Executive Summary ODAC meetings are usually few and far between – and rarely come with good news for the sponsor. Below are some lessons learned from the bounty (three!) held this week. The US Food and Drug Administration’s Oncologic Drugs Advisory Committee is always fodder for interesting discussion, given that any application that Oncology…
In little over seven years, FDA Breakthrough Therapy Designation has been given to almost 200 drugs, resulting in more than 70 treatments being approved approximately two years earlier than would otherwise have been expected, according to Dr. Jeff Allen, CEO at Friends of Cancer Research (FoCR). First passed by Congress in 2012, the designation…
Armed with a recently awarded five-year $20 million contract from the US Food and Drug Administration to support its work on the PrecisionFDA platform, DNAnexus is working with Deloitte to enhance the platform’s capabilities for sponsor-reviewer interaction, add support for multi-omics, and provide a library of analytical, statistical, and machine-learning applications. The features will…
In recent years, considerable bipartisan Congressional action, leadership from both Democratic and Republican administrations, and broad-based multistakeholder collaborations have focused on improving the tools and regulatory processes at the Food and Drug Administration (FDA), other government agencies, and public-private collaborations to support more efficient and timely development of new medical technologies. Enhanced funding through user…
The Senate Committee on Health, Education, Labor and Pensions voted 18-5 in favour of advancing Hahn’s nomination to the full Senate last week, after he was put forward for the job by President Donald Trump. Following the final confirmation, Hahn will now go on to head the FDA and become a pivotal figure on…
Executive Summary Bipartisan Senate confirmation vote comes despite concerns about Stephen Hahn’s non-answers to e-cigarette regulation questions. Stephen Hahn cruised to confirmation as the next US Food and Drug Administration commissioner 12 December, but not without another warning that his yet-to-be articulated stance on vaping will be closely scrutinized. Hahn was confirmed by the…
