In regard to the Food and Drug Administration, the sequestration could ultimately cost lives. Breakthrough medicines that could save lives may not reach patients as fast as possible, in part because FDA funding has been cut by $209 million — or more than 5 percent. That figure includes $85 million in user fees already paid…
A new regulatory pathway could shave years off the traditional drug approval process in the United States, according to some companies whose drugs have been given “breakthrough therapy” designation by the U.S. Food and Drug Administration. Speaking at a briefing in Washington to raise awareness of the drug review process, Dr. Jay Siegel, head of…
National Cancer Institute scientists have released the largest-ever database of cancer-related genetic variations, providing researchers the most comprehensive way so far to figure out how to target treatments for the disease. Open access worldwide to the new database, based on genome studies, is expected to help researchers accelerate development of new drugs and better match…
BALTIMORE — Advocates of robust funding for biomedical research have a busy week ahead of them in their efforts to restore the budget for the National Institutes of Health. Sen. Barbara Mikulski (D-Md.), chair of the powerful Senate Appropriations Committee, reiterated her feelings on restoring nearly $1.5 billion in automatic spending cuts the NIH suffered…
FDA’s much-anticipated guidance on expedited programs for drug development fills in some blanks on the new breakthrough designation, but simply advising sponsors they will need to pick up the pace on manufacturing plans and development of companion diagnostics leaves aspiring applicants wanting more, stakeholders said at DIA. FDA is likely to be more accepting of…
Recent FDA guidance laying out requirements, processes, and definitions related to the agency’s expedited drug development programs shows that the new breakthrough program should be used alongside other development tools, sources said in response to the FDA Safety and Innovation Act-mandated document. The guidance offers the first regulatory reference to the new breakthrough pathway, reinforcing…
The proportion of U.S. men with early, slow-growing prostate cancer who received robotic surgery and other expensive treatments increased between 2004 and 2009, according to a new study. Researchers found that use of those therapies also rose among men who were unlikely to die from prostate cancer because they were sick with other chronic diseases…
Maybe more than any other person alive, Richard Pazdur, the director of the Food and Drug Administration’s Office of Oncology and Hematology Products, personifies the tension between the need to get new drugs to patients fast and the competing desire to make sure they are safe and effective first. To his critics, he is an…
In the push to match medical therapies to the genetic underpinnings of disease, lung-cancer treatments have been at the frontier. But the 1.6 million people diagnosed with this cancer every year will take scant comfort in knowing that of the past 20 late-stage trials of drugs to treat it, only two yielded positive results. And in…
FDA appears to be acting more like a development partner than a regulator in dealing with a “breakthrough” therapy designee, based on the experience of one sponsor. “You actually can go in and ask for clarity on what’s expected,” Kunkel said. Pharmacyclics Inc. Chief Medical Officer Lori Kunkel said early discussions about ibrutinib, which holds…
