A new partnership between Pfizer, EMD Serono, Friends, and SITC is looking at the overarching goal of identifying opportunities within the evolving field of immunotherapy and prioritize policy changes necessary to address challenges and accelerate progress for patients. By initially convening a small, but representative group of scientific, clinical, patient, policy and industry thought leaders to shape a multi-stakeholder process,…
As the growing wave of excitement over immunotherapies has swept through the cancer field, a concern has followed in its wake: Are there now too many clinical trials for these novel treatments, which enlist the immune system to battle tumors? One recent tally found more than 1100 studies combining a popular new class called checkpoint…
Few Washington insiders doubt that a bill that allows terminally ill patients to circumvent FDA as they pursue Hail Mary pass therapies will become the law of the land. Collectively known as the “Right to Try” law, the legislation has been passed by both chambers of Congress. The bills, which bear the names of…
Executive Summary Generic labels can’t easily be changed if reference product is withdrawn, meaning legislative fix is needed to add current recommendations to outdated labels. The US FDA believes it needs legislation empowering its desire to push manufacturers to update old and outdated drug labels. Amid discussion of the problems associated with labels…
Four former commissioners of the Food and Drug Administration are expressing opposition to congressional “right to try” legislation, just as Republican House leaders prepare to bring a bill up for another vote a week after it failed to pass. The legislation is designed to allow seriously ill patients to bypass the FDA to get…
Executive Summary CDER’s OHOP, as well as relevant CBER and CDRH staff, should be folded into OCE, which should have final sign-off on all oncology products, ASCO and Friends of Cancer Research say. A restructuring of staff within the US FDA to strengthen the Oncology Center of Excellence (OCE) is one of the primary…
The House on Tuesday evening was poised to vote on a bill intended to give dying patients greater access to experimental treatments, but it was unclear whether Republican leaders had enough votes to pass it under a fast-track process. Even if it does pass, the sponsor of the Senate version said it was uncertain how…
Terminally ill patients would be put at risk by changes to a House bill giving them access to experimental drugs, bioethicists and patients groups told Bloomberg Law. The bill, set to be voted on in the House March 13, narrowed the Senate version’s definition of who could seek unapproved drugs. It also expanded the…
Executive Summary US House rejects tempered legislation as many stakeholders remain opposed – but vote allows members to signal to the Trump administration that they tried. Right to try efforts on Capitol Hill are left searching for answers and maybe another legislative pathway after the defeat of House legislation on March 13. The…
