Category: In the News

Analysis of meetings in FDA’s public calendar indicates Commissioner Hamburg, other senior leaders continue to attend meetings throughout the U.S. and overseas; stakeholders worry sequester-induced travel cuts prevent rank-and-file scientists from attending helpful events. FDA Commissioner Margaret Hamburg lamented the toll sequestration has taken on her agency’s travel budget during the keynote speech she gave…

Nearly every oncologist can tell the story of cancer patients who beat the odds, responding so well to treatment that they continued to live many years disease-free, while most of their peers worsened and eventually died. Dr. David Solit decided to find out why. Solit, an oncologist at Memorial Sloan-Kettering Cancer Center in New York…

  In August I had the pleasure of participating in Fierce’s “Understanding Major Regulatory Change” webinar. This session was about the FDA’s new “Breakthrough Therapy” designation, and I was joined by Dr. Jay Siegel from Johnson & Johnson ($JNJ) and James Pierce from Appian Corporation for a lively discussion. In case you missed it, you…

Cancer treatment has grown so complex, many U.S. doctors can’t keep up with new information and are offering incorrect treatment, failing to explain options and leaving patients to coordinate their own care, according to a report released on Tuesday by the Institute of Medicine, part of the National Academy of Sciences. The 315-page report, “Delivering…

  The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012. FDASIA section 902 provided for a new designation, the breakthrough therapy designation, for new drugs. Since last July, the agency has received a total of 82 applications for the designation, and has published a draft guidance…

In his first-floor office in the main building of the National Institutes of Health, Dr. Francis Collins, the director of the institutes, has hung a series of framed pictures. Placed in two equal-length rows of three pictures, they show him sharing the stage with President Barack Obama, talking with Senate Majority Leader Harry Reid (D-Nev.),…

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…