Medicare officials are evaluating new approaches to finding the most effective cures for cancer. Researchers developing more targeted therapies are anxious to see whether cancer drugs approved for use in one part of the body might be useful if a similar form of the disease appears elsewhere. Medicare data indicates that on average about 1…
FDA’s biologics center grants accelerated approval to the first U.S. vaccine targeting serogroup B meningococcal disease after a 4.5-month review; the vaccine is expected to come up for discussion, but not a vote, at CDC’s Advisory Committee on Immunization Practices meeting Oct. 30. FDA clearance of Pfizer Inc.’s meningococcal group B vaccine Trumenba marks the Center for Biologics…
A conversation on the past, present and what the future holds for battling disease. With billions of dollars being spent in research and development each year, with thousands of grassroots and fundraising events focused on curing cancer being held each year, with science and technology rapidly evolving in every part of our lives, many Americans,…
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs…
Advances in understanding the molecular basis of cancer have led to an escalation in comprehensive panels of multi-marker gene assays of cancer-driver mutations, as opposed to traditional single-marker assays. While such next-generation based cancer panels can be a boon in helping oncologists choose the right treatments for the right patients, the procedure is also fraught…
LUNGevity Foundation announces Friends of Cancer Research Chairperson and Founder Ellen Sigal, PhD, and Executive Director Jeff Allen, PhD, as the September LUNGevity Heroes for the work they have done advocating for policies to improve health outcomes and cancer care and for forming important partnerships that have resulted in the creation of groundbreaking initiatives such…
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…
