Days after the White House announced a new precision-medicine initiative, an influential group of US lawmakers has released its own wish list for biomedical research. On 27 January, several members of the House of Representatives released the first draft of their long-anticipated proposalto speed the translation of research into medicine. The effort, known as 21st Century Cures,…
Representatives from the pharmaceutical and biotechnology industries said last Friday (Dec. 12) they expect work on the bipartisan 21st Century Cures initiative this spring to be a staging ground for negotiations over the sixth iteration of the Prescription Drug User Fee Act (PDUFA) in 2016 and 2017. Industry leaders also said they expected the biotechnology…
More than 60% of US prescriptions for cancer drugs call for using the medicines in ways that are not approved by the government. Often, they are the only hope against a fatal illness that has thwarted conventional treatments. But although such ‘off-label’ use is common, it is hard to know how effective it is because…
FDA’s evaluation of the first two years of the breakthrough therapies program found common threads among designation requests that were granted and denied, which may help sponsors better understand the agency’s criteria for awarding the incentive. Below are key characteristics of products that have gained and were denied breakthrough designation, as well as reasons why…
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…
