House Republicans’ bid to lift the hopes of terminally ill patients failed in an unexpectedly tight vote Tuesday night. The House of Representatives failed to deliver the deciding vote for a right-to-try bill that President Donald Trump touted in his State of the Union address and would have given terminally ill patients — or…
In President Trump’s first State of the Union address, he challenged Congress to give people who are terminally ill immediate access to experimental treatments without going through the FDA. A number of states have already passed such “right-to-try” laws. The Senate has passed a federal version, and a revised version is now under consideration in…
We’re dying to participate in clinical trials. This was the message METUP delivered at the 2017 San Antonio Breast Cancer Symposium. Access to clinical trials must be an option for all people with advanced and metastatic cancers. Until then, Right to Try (RTT) legislation gives us another option. At a time when only…
House Energy & Commerce Committee Republicans’ attempts to craft a Right to Try bill that patient advocates can support appears to have failed, with major groups refusing to back anything that cuts FDA out of the process. However the new bill does appear to answer many of the concerns laid out by FDA Commissioner Scott…
THE SOLOMON CENTER for Health Law and Policy at Yale Law School, in collaboration with Smilow Cancer Hospital and Yale Cancer Center, New Haven, hosted a major interdisciplinary conference addressing topics at the cutting edge of cancer policy. The 2-day program took place on February 8–9, 2018, and brought together leading figures in the worlds…
FDA Commissioner Scott Gottlieb on Tuesday (March 6) spotlighted the agency’s efforts to reform the premarket review process for diagnostic tests, and he previewed next steps, which include qualifying third-party reviewers and third-party databases to help with reviews and approvals, reducing regulatory burden on next generation sequencing (NGS) developers, and providing flexibility in clinical analysis…
Why wouldn’t you support a patient with a terminal illness the “right to try” any therapy that may save his or her life? The answer to this question—one engulfed in a political debate in Congress—seems simple. It is not. I firmly believe that someone with a late-stage terminal illness should have the chance to…
After missing the Feb. 28 decision date, the Centers for Medicare & Medicaid Services (CMS) said it will “soon” issue a final National Coverage Determination (NCD) for next-generation sequencing (NGS) cancer diagnostics, including FoundationOne CDx from Foundation Medicine Inc. (NASDAQ:FMI). FoundationOne was granted a proposed NCD on Nov. 30, 2017, simultaneous with its FDA…
At various sessions during Cambridge Healthtech Institute’s Molecular Medicine Tri-Conference earlier this month, representatives from the diagnostics arena, pharmaceutical companies, and the medical oncology field discussed the main challenges and unknowns they believe will impact the future of cancer immunotherapy and associated diagnostic testing. The immuno-oncology community is facing a number of important questions…
Researchers have combed through the genomes of more than 1,700 tumours, representing more than 20 different kinds of childhood cancer, to unearth potential drug targets and a better understanding of how cancer arises in the youngest patients. The work, published by two teams on 28 February in Nature1,2, is part of a growing movement…
