Novartis picked up its third breakthrough therapy designation from the FDA, a coveted record number of programs in the Big Pharma crowd. The agency tapped BYM338 (bimagrumab), an antibody developed in collaboration with MorphoSys for a rare and potentially lethal muscle-wasting disease called sporadic inclusion body myositis. According to Novartis ($NVS), the agency issued the breakthrough designation…
Kellie Carey’s doctor finally stopped dodging questions about how long she had to live six weeks after he diagnosed her lung cancer. “Maybe three months,” he told her in his office one sunny May morning in 2010, she recalls. Yet she is still alive, a testament to the most extraordinary decade of progress ever…
Approvals of first-in-class drugs have remained consistent throughout recent decades, according to an FDA analysis of innovative drug approvals that the agency hopes will influence future policies geared toward increasing drug development. FDA defined three categories of new molecular entity approvals in developing metrics that go beyond using the annual number of approvals to…
Before a new drug can get to patients, it goes through years of research and development followed by a series of preclinical and clinical trials and then is subject to what’s often a drawn-out federal approval process. That whole cycle – which can take an average of 10 to 15 years and cost more than…
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…
