21st Century Cures Initiative – House Energy and Commerce Committee’s FDA, healthcare reform initiative – gets praise for its all-encompassing assessment of biomedical innovation process, but necessary legislative fixes may not come all at once. BOSTON – The House Energy and Commerce’s 21st Century Cures Initiative may be more likely to produce a variety of separate legislative…
ON Aug. 6, researchers announced in The New England Journal of Medicine that they had found that mutations in a gene called PALB2 greatly increase the risk of breast cancer. This is one of the biggest developments since the discovery in the ’90s of the role of mutations in the BRCA1 and BRCA2 genes in breast…
Scott Gottlieb, M.D., American Enterprise Institute, and Jeff Allen, Friends of Cancer Research executive director, discuss the FDA’s drug approval process and the need in some cases to allow access to experimental therapies. http://video.cnbc.com/gallery/?video=3000298861
Novel drug and biologic applications with user fee goals in 2014’s second half cluster around infectious disease – notably hepatitis C, with three “breakthrough” drugs pending, antibiotics and meningitis B vaccines (also designated “breakthroughs”) – and oncology, where the first regulatory tests of the highly anticipated PD-1 immune checkpoint inhibitors are coming up. With 11…
To the Editor: Darrow et al. (March 27 issue)1 present an incomplete and misleading review of the Food and Drug Administration (FDA) programs that are available to expedite drug development, review, and approval. As the authors note, drug regulation involves balancing the potential benefits of access to a therapy against the potential risks associated with the…
A bold new way to test cancer drugs started Monday in hundreds of hospitals around the U.S. In a medical version of speed dating, doctors will sort through multiple experimental drugs and match patients to the one most likely to succeed based on each person’s unique tumor gene profile. It’s a first-of-a-kind experiment that brings…
A new way of evaluating tumors may soon help cancer patients identify the underlying genetic link to their disease – and the best possible treatment – all in a single test. Researchers are set to begin clinical trials using a more comprehensive testing method that looks for all of the known genes that may be…
Final guidance on expedited regulatory pathways suggests FDA is open to accelerated approval for some acute conditions; agency also provides examples outside of HIV/cancer arena where surrogate and intermediate clinical endpoints have supported approval. FDA’s final guidance on expedited programs for drugs and biologics takes a more welcoming approach to the use of accelerated approval…
The nation will mark two important cancer milestones this year: the 1964 Surgeon General’s Report on Smoking and Health and the founding of the American Society of Clinical Oncology (ASCO), which ushered in a medical specialty focusing specifically on cancer care. Fast forward 50 years and there is a lot to celebrate. Cancer deaths dropped…
Colorado, Missouri and Louisiana are poised to become the first states in the nation to give terminally ill patients the right to try experimental drugs without the blessing of the Food and Drug Administration, setting the stage for what could be a lengthy battle over who should decide whether a drug is too risky to try. Lawmakers…
